915 KAR | Title 915 KAR — Cabinet for Health and Family Services - Office of the Secretary - Medicinal Cannabis Program

Chapter 1 General

915 KAR 1:001 Definitions for 915 KAR Chapter 1 {#sec-915-kar-1-001 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:001}

Section 1. Definitions.

(1) "Accreditation body" means an impartial non-profit organization that operates in conformance with the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing.

(2) "Advertising" means the publication, dissemination, solicitation, or circulation, for a fee, that is visual, oral, written, or electronic to induce directly or indirectly an individual to patronize a cannabis business or to purchase medicinal cannabis.

(3) "Advertising device" means any billboard, sign, notice, poster, display, or other device, including the structure erected or used in connection with the display or device and all lighting or other attachments used in connection with the display or device, that is:

(a) Operated or owned by a person or entity who is earning compensation directly or indirectly from a third party or parties for the placement of a message on the device; and

(b) Intended to attract the attention of operators of motor vehicles on the highways.

(4) "Agent" means a person who acts on behalf of another person or group.

(5) "Applicant" means a person or entity, including any parent entity, who applies for a cannabis business license to operate as a cultivator, processor, producer, dispensary, or safety compliance facility in the Commonwealth.

(6) "Appropriate signs" means exterior signage that accurately reflects a cannabis business's legal name, business name, "doing business as" name, or trade name and contact information on record with the cabinet.

(7) "Cabinet" means the Cabinet for Health and Family Services.

(8) "Cannabis business" is defined by KRS 218B.010(3).

(9) "Cannabis business activities" means growing, cultivating, processing, producing, packaging, labeling, transporting, dispensing, or testing medicinal cannabis.

(10) "Cannabis business agent" is defined by KRS 218B.010(4).

(11) "Cannabis business category" means Tier I cultivator, Tier II cultivator, Tier III cultivator, Tier IV cultivator, processor, producer, dispensary, or safety compliance facility.

(12) "Canopy" means the total surface area within a cultivation area that is dedicated to live plant production.

(13) "Cardholder" is defined by KRS 218B.010(5).

(14) "Certificate of accreditation" means a document issued by an accreditation body evidencing that a safety compliance facility is in compliance with International Organization for Standardization Standard ISO and IEC 17025 and other requirements relevant to the operation of laboratories conducting tests on medicinal cannabis and other items used in the growing, processing, or dispensing of medicinal cannabis.

(15) "Certificate of analysis" means a document that confirms that the test performed by a safety compliance facility on a harvest batch or production batch meets the testing requirements set forth by the cabinet.

(16) "Chain of custody" means the process used by employees or agents of a cannabis business or authorized agents of the cabinet to record the possession and transfer of medicinal cannabis samples or test samples from the time the samples are collected until testing is completed and the samples are destroyed.

(17) "Controlled incineration" means the controlled burning of medicinal cannabis in an enclosed, secured limited access area capable of capturing and neutralizing any exhaust, fumes, or fugitive odors and is capable of protecting the operator and surrounding individuals from intoxication.

(18) "Cultivation activities" means the activities involved with growing, cultivating, and selling medicinal cannabis, including planting, raising, harvesting, trimming, testing, packaging, labeling, transferring, transporting, and storing medicinal cannabis.

(19) "Cultivator" is defined by KRS 218B.010(6).

(20) "Daycare center" means "child-care center" as defined by KRS 199.894(3).

(21) "Designated caregiver" is defined by KRS 218B.010(8).

(22) "Dispensary" is defined by KRS 218B.010(9).

(23) "Disqualifying felony offense" is defined by KRS 218B.010(11).

(24) "Enclosed, locked facility" is defined by KRS 218B.010(12).

(25) "Food grade" means a non-toxic material that is safe for direct contact with food.

(26) "Harvest batch" means a group of packages created from harvested medicinal cannabis plants of the same strain which were harvested at the same time. Packages of raw plant material are created from a harvest batch.

(27) "Licensee" means the recipient of a license from the cabinet authorizing a cannabis business to operate in Kentucky for the term of the license.

(28) "Limited access area" means:

(a) An area on a cultivator or producer's site or within its facility where seedlings or medicinal cannabis plants are growing; seedlings, medicinal cannabis plants, or medicinal cannabis are being loaded into or out of transport vehicles; medicinal cannabis is being packaged for sale or stored; medicinal cannabis waste is processed, stored, or destroyed; and security alarm and surveillance system devices are stored or maintained;

(b) An area on a processor or producer's site or within its facility where medicinal cannabis is being processed; medicinal cannabis is being loaded into or out of transport vehicles; medicinal cannabis is being packaged for sale or stored; medicinal cannabis waste is processed, stored, or destroyed; and security alarm and surveillance system devices are stored or maintained;

(c) An area on a safety compliance facility's site or within its facility where medicinal cannabis is being loaded into or out of transport vehicles, stored, tested, or destroyed and where security alarm and surveillance system devices are stored or maintained; or

(d) An area on a dispensary's site or within its building where medicinal cannabis is being loaded into or out of transport vehicles, stored, or destroyed and where security alarm and surveillance system devices are stored or maintained.

(29) "Local government" means a city, county, urban-county government, consolidated local government, charter county government, or unified local government.

(30) "Medicinal cannabis" is defined by KRS 218B.010(15).

(31) "Medicinal cannabis accessories" is defined by KRS 218B.010(16).

(32) "Medicinal cannabis practitioner" is defined by KRS 218B.010(17).

(33) "Medicinal cannabis product" is defined by KRS 218B.010(18).

(34) "Medicinal cannabis waste" means:

(a) Solid, liquid, semi-solid, or contained gaseous materials that are generated by a cultivator, processor, producer, or safety compliance facility;

(b) Unused, surplus, returned, recalled, contaminated, or expired medicinal cannabis;

(c) Medicinal cannabis plant material that is not used in the growing, harvesting, processing, or testing of medicinal cannabis, including flowers, stems, trim, leaves, seeds, dead medicinal cannabis plants, dead seedlings, unused medicinal cannabis plant parts, unused seedling parts, or roots;

(d) Medicinal cannabis that exceeds any maximum allowable testing limit or fails to meet any other standards or requirements set forth in 915 KAR 001:110;

(e) Spent hydroponic nutrient solution;

(f) Containers used for:

Growing seedlings or medicinal cannabis plants or for use in the growing of medicinal cannabis; and
Processing of medicinal cannabis.

(g) Used or unused fertilizers and pesticides;

(h) Used or unused solvents, chemicals, or excipients;

(i) Samples that have been tested;

(j) Excess samples that will not be tested; and

(k) Wastewater.

(35) "Minor" is defined by KRS 218B.010(19).

(36) "Pesticide" means:

(a) Any substance or mixture of substances intended to prevent, destroy, control, repel, attract, or mitigate any pest;

(b) Any substance or mixture of substances intended to be used as a plant regulator, defoliant, or desiccant;

(d) Any fungicide used to kill or prevent the growth of fungi and their spores; and

(e) Any substance or mixture of substances intended to be used as a spray adjuvant, once they have been mixed with an EPA-registered product.

(37) "Principal officer" means a person who has ultimate responsibility for implementing the decisions of the cannabis business's governing body, or for supervising the management, administration, or operation of the cannabis business.

(38) "Processing activities" means the activities involved with processing raw plant material and medicinal cannabis into medicinal cannabis products, including acquiring, purchasing, possessing, processing, preparing, manufacturing, manipulating, blending, packaging, labeling, transferring, transporting, supplying, or selling medicinal cannabis or medicinal cannabis products to other cannabis businesses in the Commonwealth.

(39) "Processor" is defined by KRS 218B.010(21).

(40) "Producer" is defined by KRS 218B.010(23).

(41) "Product example" means a limited amount of medicinal cannabis or medicinal cannabis product that has been designated by a dispensary for display on its premises for the sole purpose of product education for cardholders.

(42) "Production batch" means a group of packages created from a production run of medicinal cannabis and indicates the medicinal cannabis in the packages has changed forms chemically or physically, which severs previous test results from those packages and requires new testing to be completed.

(43) "Qualifying medical condition" is defined by KRS 218B.010(26).

(44) "Raw plant material" is defined by KRS 218B.010(27).

(45) "Registered qualified patient" is defined by KRS 218B.010(28).

(46) "Registry identification card" is defined by KRS 218B.010(29).

(47) "Safety compliance facility" is defined by KRS 218B.010(30).

(48) "Sample" means medicinal cannabis randomly selected from a harvest batch or production batch and collected by an employee or agent of a cannabis business or an authorized agent of the cabinet for testing by a safety compliance facility. "Sample" includes both a primary sample and a reserve sample.

(49) "Sampler" means an employee or agent of a cultivator, processor, producer, safety compliance facility, or dispensary that is authorized by his or her employer to collect samples or test samples in accordance with the contracted safety compliance facility's standard operating procedures and 915 KAR 1:060.

(50) "School" means a public elementary or secondary school of the state and non-public schools certified by the Kentucky Department of Education.

(51) "Seedling" is defined by KRS 218B.010(32).

(52) "Serious violation" is defined by KRS 218B.010(33).

(53) "Smoking" is defined by KRS 218B.010(34).

(54) "Test sample" means an amount of medicinal cannabis or medicinal cannabis products, or amount of soil, growing medium, water, or solvents used to grow or process medicinal cannabis, dust, or other particles obtained from the swab of a counter or equipment used in the growing or processing of medicinal cannabis, or other item used in the growing or processing of medicinal cannabis in a facility taken by an employee or agent of a cannabis business or an authorized agent of the cabinet and provided to a safety compliance facility for testing.

(55) "Transport vehicle" means a vehicle that is used to transport seeds, seedlings, medicinal cannabis plants, medicinal cannabis, and medicinal cannabis products between cannabis businesses or between a dispensary and registered qualified patients or designated caregivers.

(56) "Visiting qualified patient" is defined by KRS 218B.010(38).

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations to administer the medicinal cannabis program in the Commonwealth. This administrative regulation establishes definitions of terms used by the cabinet in administrative regulations pertaining to cannabis businesses and the medicinal cannabis program.
History: 50 Ky.R. 1805, 2413; 51 Ky.R. 287; eff. 8-28-2024.

915 KAR 1:010 Initial and renewal applications for cannabis business licenses {#sec-915-kar-1-010 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:010}

Section 1. Types of Applications for Cannabis Business Licenses.

(1) The cabinet shall accept the following types of applications for cannabis business licenses:

(a) Initial application; and

(b) Renewal application.

(2) By submitting an initial or renewal application to the cabinet, an applicant consents to any investigation of the applicant's ability to meet the requirements of KRS Chapter 218B and 915 KAR Chapter 1.

(3) An application for an initial license or renewal license shall be incomplete and shall be rejected by the cabinet unless:

(a) The payment of the applicable fee established in Section 2 or Section 4 of this administrative regulation is submitted with the application; and

(b) All required information for each section of the application, including attachments and any supplemental information requested by the cabinet, is submitted to the cabinet within the allowable time period.

(4) An application submitted under this administrative regulation shall contain the following statement acknowledged by the applicant: "A false statement made in this application is punishable under the applicable provisions of KRS 523.100."

Section 2. Initial License Application Fees. An applicant for an initial cannabis business license shall pay the applicable application fee by credit card or automated clearing house (ACH) transfer at the time of application submission to the cabinet. The initial application fee shall be nonrefundable except as established in Section 3(6) of this administrative regulation. The initial license application fees shall be:

(1) Tier I cultivator: $3,000;

(2) Tier II cultivator: $10,000;

(3) Tier III cultivator: $20,000;

(4) Tier IV cultivator: $30,000;

(5) Processor: $5,000;

(6) Producer: $5,000 plus the applicable cultivator tier application fee;

(7) Dispensary: $5,000; and

(8) Safety Compliance Facility: $3,000.

Section 3. Initial Applications for Cannabis Business Licenses.

(1) An initial license shall be valid for one (1) year from the date of issuance shown on the license. The cabinet shall publish notice of initial license application availability on the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov, including the time frame during which initial license applications shall be accepted. This notice shall also state the category and number of cannabis business licenses available for issuance at the close of the application period.

(2) An applicant shall only use the initial license application form prescribed by the cabinet and made available through the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(3) An applicant shall submit an initial license application to the cabinet in the manner prescribed by the application instructions.

(4) An applicant shall apply for a separate license for each location where it intends to operate a cannabis business. During an initial license application availability period, an applicant shall only apply for a license in one (1) cannabis business license type (cultivator, processor, producer, dispensary, or safety compliance facility) being offered at that time. An applicant may submit multiple applications for a license within one (1) cannabis business license type if the following criteria is met:

(a) Each application shall contain a separate and distinct physical address where the applicant proposes to conduct cannabis business activities;

(b) Each application shall contain documentation of sufficient capital in accordance with subsection (5)(q) of this section and the applicant shall not use the same capital for more than one (1) application;

(c) For the four (4) cannabis cultivator tiers, an applicant shall only submit one (1) application per cultivation tier; and

(d) For dispensaries, an applicant shall only submit one (1) application per medicinal cannabis region as identified in 915 KAR 1:020, Section 3 and shown on the map published on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(5) In the initial license application, the applicant shall submit:

(a) The legal name, business type, any trade or doing business as (DBA) name, mailing address, federal tax identification number, Web site (if any), email address, and phone number of the proposed cannabis business and confirmation that the entity is registered with the Kentucky Secretary of State in good standing and authorized to do business in Kentucky;

(b) The type of cannabis business license requested;

(d) The proposed location of cannabis business activities, including the physical address of the proposed cannabis business and the global positioning system (GPS) coordinates for any proposed cannabis business activities as well as:

Documentation such as a contingent agreement for property sale or lease or an existing deed or lease that shows the applicant has the authority to use the proposed location as a cannabis business for, at a minimum, the term of the license; and
A site plan for the proposed cannabis business.

(e) The name, address, date of birth, and curricula vitae or resume of each principal officer and board member of the proposed cannabis business as well as any additional information required by the cabinet;

(f) Disclosure of any individual or business entity with an ownership interest of at least ten (10) percent equity or similar interest in the proposed cannabis business and each identified individual or entity's ownership percentage as well as any additional information required by the cabinet;

(g) Disclosure of any parent company or parent individual that has an ownership interest in the proposed cannabis business and each identified individual or entity's ownership percentage as well as any additional information required by the cabinet;

(h) A document showing the ownership organizational structure of the proposed cannabis business;

(i) The name and address of any individual or entity providing financial support to the proposed cannabis business that are not involved in the day-to-day operations beyond providing financial resources as well as any additional information required by the cabinet;

(j) The name and address of any physician or advanced practice registered nurse that has an ownership or investment interest in or compensation agreement with the proposed cannabis business as well as any additional information required by the cabinet;

(k) Disclosure of whether any principal officer or board member of the applicant has been convicted of a felony criminal offense, and if so, a description of each felony offense;

(l) Disclosure of any instances in which a business or not-for-profit entity that any of the applicant's board members managed or served on the board of was convicted, fined, censured, or had a registration or license suspended or revoked in any administrative or judicial proceeding;

(m) If applicable, documentation that the applicant is capable of successfully establishing and operating a cannabis business in the Commonwealth, including:

Demonstrated experience establishing and operating a for-profit or nonprofit organization or other business within Kentucky or any other jurisdiction, and the nature of the business conducted by the organization;
Any history relating to receipt of a similar license or other authorization in other jurisdictions, including provisional licenses, suspensions, revocations, or disciplinary actions to include civil monetary fines or warnings; and
Any history of response to suspensions, revocations, disciplinary actions, civil monetary fines, or warnings imposed relating to any similar license or other authorization in another jurisdiction, and the plans of correction or other responses made to those actions.

(n) A description of the duties, responsibilities, and roles of each principal officer, board member, employee, and any other individual or entity with a financial interest in the proposed cannabis business who are not involved in the day-to-day operations of the business;

(o) A timeline showing the steps and estimated amount of time the applicant shall take to begin cannabis business activities in the Commonwealth;

(p) A financial plan for the proposed cannabis business, including budget and cash flow planning and debt management;

(q) Documentation of sufficient capital available to the applicant, either on deposit or through extension of credit from one (1) or more financial institutions, in the following amounts as applicable:

Tier I cultivator: $50,000;
Tier II cultivator: $200,000;
Tier III cultivator: $500,000;
Tier IV cultivator: $1,000,000;
Processor: $150,000;
Producer: $150,000 plus the applicable cultivator tier amount;
Dispensary: $150,000; or
Safety Compliance Facility: $150,000.

(r) A summary of the intended plan of operation that describes, at a minimum, how the applicant's proposed cannabis business operations shall address:

Security;
Employee qualifications, supervision, and training;
Transportation of medicinal cannabis;
Storage and labeling of medicinal cannabis;
Inventory management;
Recordkeeping;
Preventing unlawful diversion of medicinal cannabis; and
Workforce development and job creation.

(s) The name, mailing address, business title, phone number, and email address of the primary contact for the application as well as the name, address, and email address of any entity or individual who assisted the applicant with preparing the application;

(t) Documentation of any management service agreement in place for the proposed cannabis business;

(u) A notarized signature page signed by the applicant; and

(v) An attestation that:

The site of the proposed cannabis business is not within 1,000 feet of an existing elementary or secondary school or a daycare center. For the purpose of this administrative regulation, 1,000 feet shall be measured in a straight line from the nearest property line of an existing elementary school, secondary school, or daycare center to the nearest property line of the applicant's proposed place of business;
The applicant can continuously maintain sufficient capital for operations of its proposed cannabis business for, at a minimum, the term of the initial license;
The applicant can continuously maintain effective security, surveillance, and accounting control measures to prevent diversion, abuse, and other illegal conduct regarding medicinal cannabis;
The applicant shall comply with KRS Chapter 218B and 915 KAR Chapter 1;
The applicant consents to the cabinet verifying information provided in the application with any relevant governmental agency or third party;
If issued a license, the applicant shall pay the applicable license fee within fifteen (15) calendar days of notification in a manner prescribed by the cabinet;
If issued a license, the applicant shall conduct a criminal background check into the criminal history of each person seeking to be a principal officer, board member, agent, volunteer, or employee of the cannabis business before that person begins work and shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age;
The applicant consents to reasonable inspections, examinations, searches, and seizures as contemplated by KRS Chapter 218B and 915 KAR Chapter 1;
The applicant shall obtain and maintain workers' compensation insurance for all employees in the Commonwealth and shall pay all required employer contributions to the Kentucky Office of Unemployment Insurance;
The applicant shall obtain and maintain commercial general liability insurance for $1,000,000 per occurrence and $2,000,000 per aggregate and commercial automobile insurance for any vehicle used to transport medicinal cannabis or medicinal cannabis products;
The applicant shall complete all trainings required by the cabinet for the proposed cannabis business's principals, agents, employees, and volunteers;
The applicant shall establish any standard operating procedures required by KRS Chapter 218B and 915 KAR Chapter 1 prior to the first date of cannabis business activities in the Commonwealth, including those specific to its cannabis business category. The standard operating procedures that apply to cannabis businesses include:

a. Security;

b. Recordkeeping;

c. Employee qualifications, supervision, and training;

d. Quality assurance;

e. Adverse event reporting and recall;

f. Waste disposal and sanitation;

g. Transportation of medicinal cannabis;

h. Inventory management, including storage and labeling of medicinal cannabis;

i. Cash management and anti-fraud procedures; and

j. Preventing unlawful diversion of medicinal cannabis.

For an applicant seeking a safety compliance facility license, one (1) or more of its prospective principal officers or board members shall not be a principal officer or board member of a cultivator, processor, producer, or dispensary applying to operate in the Commonwealth;
For an applicant seeking a cultivator, processor, producer, or dispensary license, one (1) or more of its prospective principal officers or board members shall not be a principal officer or board member of a safety compliance facility applying to operate in the Commonwealth;
The applicant consents to sharing medicinal cannabis sales data with law enforcement;
The applicant shall use the Commonwealth's designated electronic monitoring system and seed to sale tracking system required by KRS 218B.140 in the manner prescribed by the cabinet;
The applicant has disclosed all individuals and entities with an ownership interest of at least ten (10) percent equity or similar interest in the proposed cannabis business as well as any parent companies and parent company individuals with an ownership interest in its proposed cannabis business; and
The applicant swears or affirms that all information and documentation provided with the initial license application is true and correct.

(6) An initial license application received after the submission time frame stated in the published notice of initial license application availability shall be rejected by the cabinet without further consideration along with the return of the initial application fee.

(7) The cabinet shall acknowledge receipt of an initial application for a cannabis business license within fifteen (15) calendar days of submission by the applicant. The cabinet shall review each application to determine whether the application is complete. The cabinet shall provide written notice to an applicant when it has determined the application is complete. If the cabinet determines an application is not complete, the cabinet shall provide written notice to the applicant of the identified deficiencies in the application. The applicant shall have ten (10) calendar days from the date of the deficiency notification to cure the identified deficiencies and provide any missing information or documentation to the cabinet in the manner prescribed by the cabinet. If the applicant fails to cure any deficiency within ten (10) calendar days from the date of the deficiency notification, the cabinet shall reject the application as incomplete.

(8) The cabinet shall provide notification to applicants as to whether an application for a license has been approved or denied within forty-five (45) calendar days of receiving an application and determining it is complete. Any application denials shall be done in accordance with KRS 218B.090(2) and (4), including providing written notice to the applicant that he or she may file a written request for an administrative hearing on the application within thirty (30) calendar days after the mailing date of the notice. An applicant shall use the hearing request form prescribed by the cabinet and made available through the website for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov. An applicant shall submit the hearing request form to the cabinet in the manner prescribed by the form's instructions. Any hearing resulting from the applicant's written request shall be conducted in accordance with KRS Chapter 13B.

Section 4. License Renewal Fees. An applicant for renewal of a cannabis business license shall pay the applicable annual renewal fee by credit card or ACH transfer at the time of application submission to the cabinet. The annual renewal fee shall be refundable if the renewal application is denied. The annual renewal fees shall be:

(1) Tier I cultivator: $12,000;

(2) Tier II cultivator: $25,000;

(3) Tier III cultivator: $50,000;

(4) Tier IV cultivator: $100,000;

(5) Processor: $25,000;

(6) Producer: $25,000 plus the applicable cultivator tier annual renewal fee;

(7) Dispensary: $30,000; and

(8) Safety Compliance Facility: $12,000.

Section 5. Renewal Applications for Cannabis Business Licenses.

(1) A renewal license shall be valid for one (1) year from the date of issuance shown on the license. The requirements that a licensed cannabis business shall meet to receive an initial license are continuing requirements to maintain the license. A cannabis business shall continuously comply with the licensing requirements of KRS Chapter 218B and 915 KAR Chapter 1 during the initial licensure period and any subsequent renewal period.

(2) The cabinet shall notify each licensee at least ninety (90) calendar days prior to the date the license expires to allow the licensee to begin the renewal process if the licensee so chooses.

(3) A licensee shall only use the license renewal application form prescribed by the cabinet and made available through the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(4) A license renewal application shall be submitted to the cabinet at least sixty (60) calendar days prior to the expiration of the license. The cabinet shall reject a license renewal application if it is not submitted at least sixty (60) calendar days prior to the expiration of the license and shall return the annual renewal fee to the licensee along with written notice of the rejection.

(5) A licensee shall submit a license renewal application to the cabinet in the manner prescribed by the application instructions.

(6) A licensee shall include the following information with a license renewal application:

(a) Information regarding any charge, or any initiated, pending, or concluded investigation or proceeding, during the period of the initial license or prior renewal period, by any governmental or administrative agency, including an investigation or proceeding involving theft, loss, or possible diversion of medicinal cannabis by the licensee or from the licensee's facility;

(b) Information regarding the licensee's ability to continue with licensed activities, including any staffing issues, delays, medicinal cannabis shortages, medicinal cannabis product recalls, location issues, and financial issues that occurred since the license was issued;

(c) The licensee's history of compliance with KRS Chapter 218B and 915 KAR Chapter 1, including a summary of any noncompliance and corrective action taken during the current and any previous licensing period or a statement indicating that the licensee has not violated KRS Chapter 218B or 915 KAR Chapter 1 as of the date the renewal application is submitted; and

(d) Any additional information required by the cabinet.

(7) The cabinet shall acknowledge receipt of a renewal license application within fifteen (15) calendar days of submission by the applicant. The cabinet shall review each application to determine whether the application is complete. If the cabinet determines an application is not complete, the cabinet shall provide written notice to the applicant of the identified deficiencies in the application. The applicant shall have ten (10) calendar days from the date of the deficiency notification to cure the identified deficiencies and provide any missing information or documentation to the cabinet in the manner prescribed by the cabinet. If the applicant fails to cure any deficiency within ten (10) calendar days from the date of the deficiency notification, the cabinet shall reject the application as incomplete.

(8) If the cabinet determines that a license renewal application is lacking sufficient information upon which to make a renewal determination, the cabinet shall notify the licensee in writing of the factors that require additional information and documentation. The licensee shall have ten (10) calendar days from the date of the notice to provide the requested information and documentation to the cabinet. A licensee's failure to provide the requested information to the cabinet by the deadline shall be grounds for denial of the license renewal application.

(9) The cabinet may conduct an onsite inspection of the licensee's facilities and records to assist with determining continuing compliance with KRS Chapter 218B and 915 KAR Chapter 1.

(10) An existing cannabis business license shall be immediately invalid upon expiration if the licensee has not filed a license renewal application and paid the required renewal fee in accordance with Section 4 of this administrative regulation. If a licensee properly submits a timely renewal application with applicable renewal fee, the cabinet may extend its existing license from the date the existing license expires until the cabinet can complete its renewal application review and issue a determination.

Section 6. Minimum Performance Standards for License Renewal.

(1) Pursuant to KRS 218B.080(5)(b), the renewal of a cannabis business license shall be contingent upon successful achievement of minimal performance standards established by the cabinet. The minimum performance standards for licensees participating in the Kentucky Medical Cannabis Program shall be that:

(a) The licensee has, and is likely to continue to maintain, effective controls against diversion of medicinal cannabis at its facility;

(b) The licensee has not made false or misleading statements in:

A renewal application or any other application submitted to the cabinet;
Any document or written communication submitted to the cabinet; or
Any verbal communication to the cabinet.

(c) The licensee has a documented history of compliance with the licensee requirements in KRS Chapter 218B and 915 KAR Chapter 1;

(d) The licensee has effectively addressed any identified compliance issues through corrective action;

(e) The licensee has shown it has the ability to continue to comply with all state and local laws and administrative regulations applicable to the activities in which it may engage under the license, if renewed;

(f) The licensee has a documented history of successfully addressing and mitigating any quality or safety issues with its medicinal cannabis or medicinal cannabis products;

(g) The licensee timely completes all reporting required by KRS Chapter 218B and 915 KAR Chapter 1; and

(h) The licensee participates in surveys distributed by the cabinet and provides full, complete, and timely responses.

(2) The cabinet shall deny a renewal application for a cannabis business license if it determines the licensee has failed to:

(a) Meet one (1) or more of the minimum performance standards established in this section; or

(b) Any additional basis established in KRS 218B.090.

(3) The cabinet shall provide written notification to a licensee as to whether its renewal application has been approved or denied within forty-five (45) calendar days of receiving an application and determining it is complete. Any renewal application denials shall be done in accordance with KRS 218B.090(4), including providing written notice to the applicant that he or she may file a written request for an administrative hearing on the application within thirty (30) calendar days after the mailing date of the notice. An applicant shall use the hearing request form prescribed by the cabinet and made available through the website for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov. An applicant shall submit the hearing request form to the cabinet in the manner prescribed by the form's instructions. Any hearing resulting from the applicant's written request shall be conducted in accordance with KRS Chapter 13B.

Section 7. Duty to Report. During the application process, an applicant for an initial cannabis business license or renewal license shall, upon discovery of any change in facts or circumstances reflected in the initial application or renewal application submitted to the cabinet, notify the cabinet in writing of the change or any newly discovered fact or circumstance that would have been included in the application if known at the time the application was submitted. The notification required under this section shall be sent by electronic mail to kymedcanreporting@ky.gov within twenty-four (24) hours of discovery. Failure to timely notify the cabinet of a change or newly discovered facts or circumstances may result in denial of the application.

History

RELATES TO: KRS Chapter 13B, Chapter 218B, 523.100
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing initial application and renewal procedures for cannabis business licenses. This administrative regulation establishes those procedures.
History: 50 Ky.R. 2550; 51 Ky.R. 696, 922, 1124; eff. 11-18-2024.

915 KAR 1:020 Cannabis business licenses {#sec-915-kar-1-020 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:020}

Section 1. General Requirements for Cannabis Business Licenses.

(1) The cabinet shall issue a license, by name and address, to a cannabis business only for the specific location identified by the cannabis business during the application and issuance process. A license shall only be valid for the person or entity named in the license and only for the activity and location specified in the license.

(2) A licensed cannabis business shall conspicuously display its license within the premises of the cannabis business in a manner that is visible to visitors upon initial entry into its facility.

(3) A license shall not be issued to a cannabis business for operation within a personal residence or any other location where the cabinet or its authorized agents or law enforcement have limited access.

(4) A license shall not be issued to a cannabis business for a site or facility located on lands owned by the United States of America or the Commonwealth of Kentucky.

(5) A license shall be valid for one (1) year from the date of issuance as shown on the license.

Section 2. License Fees for Cannabis Businesses.

(1) A cannabis business shall pay the applicable license fee by credit card or automated clearing house (ACH) transfer to the cabinet within fifteen (15) calendar days of receipt of the invoice from the cabinet. The cabinet shall not issue a license to a cannabis business that fails to timely pay the applicable license fee.

(2) The initial nonrefundable license fees shall be:

(a) Tier I cultivator: $12,000;

(b) Tier II cultivator: $25,000;

(d) Tier IV cultivator: $100,000;

(e) Processor: $25,000;

(f) Producer: $25,000 plus the applicable cultivator tier initial license fee;

(g) Dispensary: $30,000; and

(h) Safety compliance facility: $12,000.

(3) The annual renewal license fees, which shall be refundable if the renewal application is denied, shall be:

(a) Tier I cultivator: $12,000;

(b) Tier II cultivator: $25,000;

(d) Tier IV cultivator: $100,000;

(e) Processor: $25,000;

(f) Producer: $25,000 plus the applicable cultivator tier renewal license fee;

(g) Dispensary: $30,000; and

(h) Safety compliance facility: $12,000.

Section 3. Initial Licensure of Cannabis Businesses and Use of Lottery.

(1) The cabinet shall publish notice of the number and category of cannabis business licenses available for distribution at the close of an initial license application period and provide the time frame during which initial license applications shall be accepted by the cabinet. This notice shall be published on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(2) To promote patient access to medicinal cannabis across the Commonwealth, the cabinet shall issue dispensary licenses within designated regions. The cabinet shall publish a map clearly identifying the medicinal cannabis regions on the Web site of the Kentucky Medical Cannabis Program. The eleven (11) medicinal cannabis regions in the Commonwealth shall be:

(a) Region 1 (Bluegrass): The geographical region comprised of the counties of Anderson, Bourbon, Boyle, Clark, Fayette, Franklin, Garrard, Harrison, Jessamine, Madison, Mercer, Scott, and Woodford;

(b) Region 2 (Kentuckiana): The geographical region comprised of the counties of Bullitt, Henry, Jefferson, Oldham, Shelby, Spencer, and Trimble;

(c) Region 3 (Northeast): The geographical region comprised of the counties of Bath, Boyd, Carter, Elliott, Fleming, Greenup, Lewis, Mason, Menifee, Montgomery, Morgan, Nicholas, Robertson, and Rowan;

(d) Region 4 (South Central): The geographical region comprised of the counties of Allen, Barren, Butler, Edmonson, Logan, Metcalfe, Monroe, Simpson, and Warren;

(e) Region 5 (Cumberland): The geographical region comprised of the counties of Bell, Casey, Clinton, Cumberland, Harlan, Knox, Laurel, Lincoln, McCreary, Pulaski, Rockcastle, Russell, Wayne, and Whitley;

(f) Region 6 (Mountain): The geographical region comprised of the counties of Breathitt, Clay, Estill, Floyd, Jackson, Johnson, Knott, Lawrence, Lee, Leslie, Letcher, Magoffin, Martin, Owsley, Perry, Pike, Powell, and Wolfe;

(g) Region 7 (Pennyrile): The geographical region comprised of the counties of Caldwell, Christian, Hopkins, Lyon, Muhlenberg, Todd, and Trigg;

(h) Region 8 (West Kentucky): The geographical region comprised of the counties of Ballard, Calloway, Carlisle, Crittenden, Fulton, Graves, Hickman, Livingston, McCracken, and Marshall;

(i) Region 9 (Lincoln Trail): The geographical region comprised of the counties of Adair, Breckinridge, Grayson, Green, Hardin, Hart, Larue, Marion, Meade, Nelson, Taylor, and Washington;

(j) Region 10 (Northern Kentucky): The geographical region comprised of the counties of Boone, Bracken, Campbell, Carroll, Gallatin, Grant, Kenton, Owen, and Pendleton; and

(k) Region 11 (Green River): The geographical region comprised of the counties of Daviess, Hancock, Henderson, McLean, Ohio, Union, and Webster.

(3) The cabinet shall issue at least four (4) dispensary licenses per medicinal cannabis region. For regions containing an urban-county government or a consolidated local government, the cabinet shall issue at least six (6) dispensary licenses, two (2) of which shall be issued to eligible cannabis businesses that physically locate their dispensary in the counties with an urban-county government or a consolidated local government. For all counties without an urban-county government or a consolidated local government, there shall not be more than one (1) dispensary per county.

(4) A dispensary licensee shall not change its retail location to another location within the same region without prior cabinet approval. A dispensary licensee shall not change its retail location to outside of the region where it was initially licensed.

(5) The licenses for cultivators, processors, producers, and safety compliance facilities are not subject to regional restrictions within the Commonwealth, and those licensees shall operate at the physical address identified on their respective licenses.

(6) Applicants for initial cannabis business licenses who comply with all application requirements contained in KRS Chapter 218B and 915 KAR 1:010, and whose applications are deemed complete by the cabinet, shall be eligible to receive the license requested. If the number of eligible applications does not exceed the maximum number of licenses available within a cannabis business category following the close of an initial license application period, the cabinet shall provide written notice to the eligible applicants that a license shall be issued to them upon timely payment of the applicable license fee. When an eligible applicant timely pays the applicable license fee, the cabinet shall issue a copy of the license to the applicant that contains the cannabis business's name, license number, physical location, issue date, and expiration date.

(7) If the number of eligible applications exceeds the maximum number of licenses available within a cannabis business category following the close of an initial license application period, the cabinet shall conduct a lottery to issue the licenses for that cannabis business category. The cabinet shall notify the eligible applicants of their entry into the lottery and publicly announce the date, time, and manner of randomly selecting eligible applicants for the requested license. A lottery to select the licensees in each cannabis business category, as needed, shall be held in a manner that can be observed by the public.

(8) The cabinet may consult or contract with a third-party lottery operator or other public agencies with relevant expertise in conducting lotteries. The entity selected to conduct the lottery shall conduct an independent lottery for each cannabis business category where the number of eligible applicants exceeds the number of available licenses. The cabinet shall assign a number to each eligible applicant in each license lottery and maintain the confidentiality of the eligible applicants and their assigned numbers until after the random drawings have occurred.

(9) The cabinet shall provide written notice to the eligible applicants selected through the lottery process that a license shall be issued to them upon timely payment of the applicable license fee. When an eligible applicant timely pays the applicable license fee, the cabinet shall issue a copy of the license to the applicant that contains the cannabis business's name, license number, physical location, issue date, and expiration date.

(10) Prior to license issuance, if an eligible applicant selected through the lottery process needs to change their location for cannabis business activities due to a local government prohibiting all cannabis business operations within its territory as authorized by KRS 218B.130 or other circumstances, a provisional license may be issued to the eligible applicant upon timely payment of the applicable license fee.

(a) Pursuant to KRS Chapter 218B and this administrative regulation, if a provisional license is issued, the provisional licensee shall have a maximum of 120 calendar days from issuance to request a change of location to an allowable county or city. If the new location is approved by the program, a new license shall be issued that contains the cannabis business's name, license number, physical location, issue date, and an expiration date which shall be one (1) year from the date of provisional license issuance.

(b) If the provisional licensee fails to request a location change within 120 calendar days from issuance or the request is denied, the cabinet shall revoke their provisional license and the license fee shall not be refunded.

(c) Provisional licenses shall not be sold or transferred to another individual or entity and shall not authorize a provisional licensee to begin any cannabis business activities.

(11) The cabinet shall provide written notice to eligible applicants that were not selected through the lottery process informing them of the same.

(12) If at the conclusion of the lottery selection process an eligible applicant declines the license or fails to pay its license fee within the required timeframe, the cabinet may conduct supplemental license lotteries as needed until all available cannabis business licenses have been issued and initial license fees paid. For any supplemental lottery for a license within a cannabis business category, eligible applicants who were not previously issued a license through the lottery process for that cannabis business category shall be entered into the supplemental lottery.

Section 4. Requirements for Licensees Prior to First Day of Cannabis Business Activities.

(1) Prior to its first day of cannabis business activities in the Commonwealth, a licensee shall provide written confirmation to the cabinet that:

(a) The licensee has complied and shall continue to comply with all applicable requirements of KRS Chapter 218B, including KRS 218B.095 and 915 KAR Chapter 1, and shall make available all records and documentation verifying compliance upon the request of the cabinet;

(b) The licensee has submitted its complete physical address and the global positioning system (GPS) coordinates for any cannabis business activities to the cabinet and confirmed its business is not located within 1,000 feet of an existing elementary or secondary school or a daycare center. For the purpose of this administrative regulation, 1,000 feet shall be measured in a straight line from the nearest property line of an existing elementary school, secondary school, or daycare center to the nearest property line of the licensee's place of business. The cabinet shall have an opportunity to inspect the location prior to the first day of cannabis business activities at that location to identify any deficiencies for correction;

(c) The licensee has conducted and shall continue to conduct criminal background checks of each person seeking to be a principal officer, board member, agent, volunteer, or employee of the cannabis business before that person begins work and shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age. The licensee shall maintain records of these background checks and provide the records to the cabinet during subsequent inspections or upon request;

(d) The licensee has obtained and shall maintain workers compensation insurance for all employees in the Commonwealth and shall pay all required employer contributions to the Kentucky Office of Unemployment Insurance;

(e) The licensee has obtained and shall maintain, at a minimum, commercial general liability insurance for $1,000,000 per occurrence and $2,000,000 per aggregate and commercial automobile insurance as required by Kentucky law, specifically KRS 304.39-110, for any vehicle used to transport medicinal cannabis or medicinal cannabis products;

(f) The licensee has established written standard operating procedures required by KRS Chapter 218B and 915 KAR Chapter 1, including those specific to its cannabis business category, and shall provide written or electronic copies of the procedures to the cabinet during inspections or upon request. The standard operating procedures that apply to cannabis businesses shall include:

Security;
Recordkeeping;
Employee qualifications, supervision, and training;
Quality assurance;
Adverse event reporting and recall;
Waste disposal and sanitation;
Transportation of medicinal cannabis;
Inventory management, including storage and labeling of medicinal cannabis;
Cash management and anti-fraud procedures;
Odor mitigation and control;
Preventing unlawful diversion of medicinal cannabis; and
Incident reporting procedures to notify the cabinet.

(g) The licensee continues to maintain sufficient capital for operations of its cannabis business for, at a minimum, the term of the license;

(h) The licensee has implemented appropriate security measures to deter and prevent theft of medicinal cannabis and unauthorized entrance into areas containing medicinal cannabis;

(i) The licensee has and shall continue to display its license at all times in a conspicuous location within the premises of the cannabis business in a manner that is visible to visitors upon initial entry into its facility;

(j) The licensee's principals, agents, employees, and volunteers have completed all trainings required by the cabinet to be completed prior to its first day of cannabis business activities in the Commonwealth;

(k) The licensee understands how to properly use the Commonwealth's designated electronic monitoring system and seed to sale tracking system for medicinal cannabis and shall use those systems as required throughout the entirety of its licensure period;

(l) The licensee has implemented appropriate odor mitigation procedures or technics to ensure the capture of any potential fugitive odors emitted by the facility;

(m) The licensee consents to reasonable inspections, examinations, searches, and seizures; and

(n) The licensee swears or affirms that all information and documentation provided to the cabinet is true and correct and that any false statement made to the cabinet by the licensee is punishable under the applicable provisions of KRS 523.100.

(2) A licensee shall also provide the cabinet with thirty (30) calendar days advance notice of its intended first day of cannabis business activities in the Commonwealth and allow the cabinet an opportunity to inspect the licensee's site and facility prior to the first day of cannabis business activities. The licensee shall promptly correct any deficiencies identified by the cabinet during this inspection and shall not commence operations until deficiencies are corrected and approved by the cabinet. If the licensee fails to provide the notice required under this subsection or fails to correct identified deficiencies, the cabinet may take one (1) or more of the actions described in Section 12 of this administrative regulation.

(3) Once a cultivator or producer has received approval from the cabinet to commence operations, the cultivator or producer shall:

(a) Bring a start-up inventory of medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants into its facility;

(b) Submit a written request to the cabinet by electronic mail to kymedcanreporting@ky.gov requesting that the cabinet open a window in the state's designated seed to sale tracking system for the cultivator or producer to enter its start-up inventory of medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants into the system. The written request shall include the number and strain of all medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants brought into the facility;

(c) Have fourteen (14) calendar days from receipt of the cabinet's approval of the cultivator or producer's written request in which to enter its start-up inventory into the state's designated seed to sale tracking system. A cultivator or producer shall enter its start-up inventory into the state's designated seed to sale tracking system as follows:

Seeds shall be entered into the system as a package; and
Seedlings, tissue cultures, and clones shall be entered into the system as a batch; and

(d) Notify the cabinet in writing by electronic mail to kymedcanreporting@ky.gov when all its start-up inventory has been fully and accurately entered into the state's designated seed to sale tracking system and confirm the number and strain of medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants brought into the facility.

(4) Following acquisition of its start-up inventory, a cultivator or producer may submit a written request to the cabinet by electronic mail to kymedcanreporting@ky.gov requesting that the cabinet open a window in the state's designated seed to sale tracking system for the cultivator or producer to enter new medicinal cannabis seeds, seedlings, tissue cultures, clones, or plants into the system. This written request shall:

(a) State the proposed date to bring new inventory into the facility; and

(b) Provide the number and strain of all new medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants that the cultivator or producer requests to bring into the facility.

(5) Upon receipt of the cabinet's approval of a written request made pursuant to subsection (4) of this section, the cultivator or producer shall have seven (7) calendar days to enter its new inventory into the state's designated seed to sale tracking system. A cultivator or producer shall enter its new inventory into the state's designated seed to sale tracking system as described in subsection 3(c) of this section. A cultivator or producer shall notify the cabinet in writing by electronic mail to kymedcanreporting@ky.gov when all new inventory has been fully and accurately entered into the state's designated seed to sale tracking system and confirm the number and strain of medicinal cannabis seeds, seedlings, tissue cultures, clones, and plants brought into the facility.

Section 5. Requirements for Licensees During Licensure Period.

(1) Except as provided in Section 10(4) of this administrative regulation, a licensee shall only hold licenses in one (1) cannabis business category at any given time. A licensee may hold multiple licenses in the same cannabis business category if each license contains a separate and distinct physical address where the cannabis business conducts licensed cannabis activities and the licensee is otherwise in compliance with the requirements of KRS Chapter 218B and 915 KAR Chapter 1, including any geographic restrictions contained in this administrative regulation.

(2) Duty to Report.

(a) During the licensure period, a licensee shall notify the cabinet in writing of any change in facts or circumstances reflected in the initial license application, supplemental written confirmations, or any license renewal application submitted to the cabinet, or any newly discovered fact or circumstance which would have been included in the application or information provided to the cabinet if known at the time the information was submitted. The duty to report shall include:

Notifying the cabinet of any physical change, alteration, or modification to a licensed facility that materially or substantially alters the facility or its usage, including an increase or decrease in the total square footage of the facility;
Significant electrical modifications that require inspection by local authorities; and
Sealing off, creation of, or relocation of a common entryway, doorway, passage, or other means of ingress or egress when the common entryway, doorway, or passage alters or changes limited access areas.

(b) During the licensure period, a licensee shall notify the cabinet following knowledge or discovery of the following events:

Inventory discrepancies;
Diversion, theft, or loss of any medicinal cannabis or medicinal cannabis product;
Unauthorized destruction of medicinal cannabis;
Any criminal proceeding involving the licensee's owners, principal officers, board members, employees, volunteers, financial backers, or agents arising out of actions taken on the licensee's premises or while using licensee property;
Security alarm activation or other event that requires response by law enforcement or security personnel;
Any loss, unauthorized dissemination, or unauthorized alteration of records related to medicinal cannabis, cardholders, employees, volunteers, or agents;
Accidents involving transport vehicles that occur while the licensee is transporting or delivering medicinal cannabis;
Any act involving cultivating, processing, producing, testing, transporting, or dispensing medicinal cannabis by any person that may create a health or safety risk to cardholders or the general public;
A dispensary declines the sale of medicinal cannabis to a cardholder; or
A dispensary desires to prohibit a cardholder from entering its premises.

Provided on a form prescribed by the cabinet and available on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov, that includes time and date of the event, individuals involved, and a detailed description of the event; and
Sent by electronic mail to kymedcanreporting@ky.gov or through the cannabis business licensing portal within twenty-four (24) hours of discovery or knowledge of the event.

(d) If a licensee fails to provide the notice required under this section, the cabinet may take one (1) or more of the actions described in Section 12 of this administrative regulation.

(e) If a local government prohibits all cannabis business operations within its territory in accordance with KRS 218B.130, a licensee located within the affected territory shall notify the cabinet in writing by electronic mail to kymedcanreporting@ky.gov within twenty-four (24) hours of notification or discovery of this prohibition, including all information known regarding the prohibition, and may make a written request to the cabinet to change its cannabis business location in accordance with Section 9 of this administrative regulation.

(3) Inspection and investigation.

(a) The cabinet may conduct announced or unannounced inspections or investigations to determine the licensee's compliance with KRS Chapter 218B and 915 KAR Chapter 1. The investigations and inspections may occur during regular working hours and at other reasonable times to inspect the licensee's place of business, question privately any principal officer, board member, agent, employee, or employee's representative, and investigate facts, conditions, practices, or other matters deemed appropriate to determine whether the licensee is operating in compliance with KRS Chapter 218B and 915 KAR Chapter 1. If a licensee refuses entry onto its premises, the cabinet may apply to the circuit court in the county in which the licensee is located for an order to enforce the right of entry.

(b) Following completion of an inspection or investigation, the cabinet shall have the authority to confiscate, possess, transport, and destroy any medicinal cannabis that has been deemed noncompliant with the standards established by KRS Chapter 218B and 915 KAR Chapter 1.

Administer oaths;
Examine witnesses under oath;
Take depositions;
Certify to official acts;
Review records and accounts;
Take photographs;
Secure any other evidence deemed necessary to evaluate compliance with KRS Chapter 218B and 915 KAR Chapter 1; and
Issue subpoenas to compel the attendance of witnesses and parties and the production of books, accounts, correspondence, memoranda, and other records considered necessary and relevant to the matter under investigation by the cabinet.

(d) When a witness or party fails to comply with a subpoena issued by the cabinet, the circuit court in the county in which the witness or party is located may compel compliance by proceedings for contempt of a subpoena or order issued from the court or a refusal to testify therein, and may adjudge a person guilty of contempt of court and punish him or her as provided by law in other contempt cases. In any proceeding brought under this paragraph, a circuit court may modify or set aside the subpoena.

(e) An investigation or inspection may include:

Inspection of a licensee's site, facility, vehicles, equipment, books, records, papers, documents, data, and other physical or electronic information;
Interviews of licensee's principal officers, board members, agents, employees, volunteers, or employee representatives;
Interviews of licensee's former principal officers, board members, agents, employees, volunteers, or employee representatives; and
Inspection of equipment, instruments, tools, machinery, and vehicles that are used to grow, process, package, transport, and test medicinal cannabis.

(f) The cabinet and its authorized agents shall have free access to review and, if necessary, make copies of books, records, papers, documents, data, or other physical or electronic information that relates to the business of the licensee, including financial data, sales data, shipping data, pricing data, and employee data.

(g) Failure of a licensee to provide the cabinet and its authorized agents immediate access to any part of a licensee's site or facility, requested material, physical or electronic information, or individual as part of an inspection or investigation may result in the imposition of a civil monetary fine, suspension, or revocation of its license, or an immediate cessation of operations pursuant to a cease-and-desist order issued by the cabinet if continued operations would present a risk to the health, safety, or welfare of cardholders or the public.

(h) The cabinet and its authorized agents shall have access to any area within a licensee's site or facility, including any area being used to store medicinal cannabis, and shall be authorized to collect samples and test samples for testing.

(4) Training.

(a) Every principal, agent, employee, and volunteer of a licensee who has direct contact with cardholders, or physically handles cannabis seeds, seedlings, tissue cultures, clones, mature cannabis plants, medicinal cannabis, or medicinal cannabis products, shall complete applicable training required by the cabinet, which may include trainings for cultivating, processing, testing, and retail sale of medicinal cannabis and usage of the Commonwealth's designated electronic monitoring system and seed to sale tracking system required by KRS 218B.140. The cabinet shall provide written notice to licensees of the availability of any required training and the frequency to complete the training.

(b) The cabinet shall publish a Guide to Worker Safety and Health in the Kentucky Medical Cannabis Industry on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov. Licensees shall maintain a physical copy of the Guide to Worker Safety and Health in the Kentucky Medical Cannabis Industry in their facility in a manner that is readily accessible to its employees or agents and ensure that employees receive annual training on the contents of the guide.

(c) A licensee shall train its principals, agents, employees, and volunteers on its established standard operating procedures within thirty (30) days of starting employment and once every calendar year thereafter.

(d) A licensee shall retain any training participation records of its principals, agents, employees, and volunteers and make them available for inspection by the cabinet upon request for a period of five (5) years.

(5) Insurance requirements.

(a) A licensee shall obtain and maintain commercial general liability insurance for, at a minimum, $1,000,000 per occurrence and $2,000,000 per aggregate.

(b) A licensee shall obtain and maintain commercial automobile insurance as required by Kentucky law, specifically KRS 304.39-110, for any vehicle used to transport medicinal cannabis or medicinal cannabis products.

(c) A licensee shall obtain and maintain workers' compensation insurance coverage for employees in the Commonwealth and shall pay all required employer contributions to the Kentucky Office of Unemployment Insurance.

(d) The insurance requirements contained in this section shall begin prior to the licensee's first day of cannabis business activities in the Commonwealth and continue for as long as the licensee is operating under a license issued by the cabinet.

(6) Reports.

(a) The cabinet may require ongoing reporting of operational and financial information from the licensee in a form and manner prescribed by the cabinet.

(b) The cabinet shall require any reports necessary to carry out its responsibilities under KRS Chapter 218B and 915 KAR Chapter 1.

Section 6. Failure to be Operational.

(1) If a licensee has not met the timeline estimates provided in its initial license application to begin cannabis business activities in the Commonwealth, the licensee shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov within two (2) calendar days of determining a need to adjust its timeline. In its written notice to the cabinet, the licensee shall identify any operational deficiencies and provide an explanation for failing to adhere to its timeline estimates.

(2) Within seven (7) calendar days of providing the written notice required under this section, the licensee shall submit a corrective action plan to the cabinet that sets forth the licensee's updated timeline and a date certain for correcting the identified operational deficiencies.

(3) If the licensee fails to comply with its corrective action plan, the cabinet may impose penalties or sanctions as outlined in Section 12 of this administrative regulation.

Section 7. Closure of a Licensed Cannabis Business Location.

(1) A licensee shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov at least thirty (30) calendar days prior to the projected date of closure, upon making a determination that it intends to close a cannabis business location.

(2) A licensee shall not accept or purchase seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, medicinal cannabis, medicinal cannabis products, medicinal cannabis accessories, equipment, or medicinal devices or instruments for the closing location as of the date of closure notice submitted to the cabinet.

(3) The notice shall be accompanied by the licensee's written plan for closing its cannabis business location that includes:

(a) The projected date of closure;

(b) How the licensee intends to notify, prior to the projected date for closure, any person or entity to which the licensee provides medicinal cannabis or medicinal cannabis services from the closing location;

(c) How the licensee intends to dispose of seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, medicinal cannabis, medicinal cannabis products, or other plant matter projected to still be at the closing location at the time of the projected closure; and

(d) How the licensee intends to dispose of equipment, devices, instruments, or medicinal cannabis accessories at the closing location.

(4) A licensee shall not remove or destroy any seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, medicinal cannabis, other plant matter, medicinal cannabis products, equipment, medicinal cannabis accessories, or medicinal devices or instruments until the cabinet has approved its plan for closing the location and shall comply with all applicable requirements regarding disposal of medicinal cannabis contained in 915 KAR Chapter 1.

(5) The cabinet may enter and inspect the cannabis business location and facilities following receipt of the licensee's closure plan to determine whether to approve the closure plan. If the cabinet denies the closure plan, it shall notify the licensee in writing and require the licensee to submit a revised closure plan within seven (7) calendar days of the date of the denial notice. The cabinet shall review and consider the revised closing plan and issue a determination within seven (7) calendar days of receipt.

(6) If the cabinet approves the licensee's closure plan, the licensee shall surrender its license for the closing location to the cabinet on or before the date for closure provided in the plan.

Section 8. Request for Approval of a Change in Cannabis Business Ownership.

(1) If there is a pending change in ownership of a licensee from the ownership listed in the initial license application, the licensee shall submit a written request for approval of a change in ownership to the cabinet by electronic mail to kymedcanreporting@ky.gov. The cabinet shall consider the requirements for ownership of a cannabis business contained in KRS Chapter 218B and 915 KAR Chapter 1 as well as any other factors that the cabinet deems relevant in making its determination on the request. The cabinet shall review the request and notify the licensee in writing whether the request is approved or denied.

(2) For each new individual or entity that is part of the proposed change in ownership, the licensee shall include in its request the information required of owners in the initial license application. The licensee shall also provide the cabinet with the names of all outgoing individuals or entities previously listed as owners.

(3) If the cabinet determines that a request for approval of a change in ownership is lacking sufficient information upon which to make a determination, the cabinet shall notify the licensee in writing of the areas that require additional information and documentation. The licensee shall have fifteen (15) calendar days from the mailing date of the notice to provide the requested information and documentation to the cabinet. A licensee's failure to provide the required information and documentation to the cabinet by the deadline shall be grounds for the denial of the requested change in ownership.

Section 9. Request for Approval of a Change in Cannabis Business Location.

(1) A licensee desiring to change the location of a site or facility shall submit a written request for approval of a change in location to the cabinet by electronic mail to kymedcanreporting@ky.gov. A change in location of a site or facility shall not occur unless the cabinet approves the change in writing. The cabinet shall consider the location requirements for a cannabis business contained in KRS Chapter 218B and 915 KAR Chapter 1 in making its determination on the request, and any other factors that the cabinet deems relevant. The cabinet shall review the request and notify the licensee in writing whether the request is approved or denied.

(2) A written request for approval of a change in location shall include the reason(s) for requesting the change and other information about the proposed new location, including:

(a) The proposed new physical address of the cannabis business and the GPS coordinates for any proposed cultivation, processing, producing, testing, or dispensing activities;

(b) Evidence that the licensee has the authority to use the proposed site as a cannabis business;

(c) Confirmation that the proposed location is not within 1,000 feet of an existing elementary or secondary school or a daycare center at the time the request is made; and

(d) A site plan for the cannabis business.

(3) If the cabinet in its discretion approves the request, the cabinet shall issue an amended license to the licensee reflecting the new physical address of the cannabis business. The expiration date of the amended license shall be the same as the expiration date of the previous license.

(4) Within ninety (90) calendar days of the issuance by the cabinet of an amended license under this section, the licensee shall change the location of its operation to the new location designated in the new license. Simultaneously, the licensee shall cease to operate at the former location and surrender its existing license to the cabinet. The following conditions shall apply:

(a) A licensee shall not operate or exercise any of the privileges granted under the license in both locations;

(b) The cabinet may extend the ninety (90) day deadline for relocation for up to an additional ninety (90) calendar days;

(c) The licensee shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov at least fifteen (15) calendar days prior to beginning cannabis business activities at the new location; and

(d) The cabinet may conduct an inspection to determine the appropriateness of the new location, and upon notification from the cabinet, the licensee shall immediately correct any deficiencies identified by the cabinet during this inspection and shall not commence operations at the new location until the deficiencies have been corrected and approved by the cabinet.

(5) For dispensary licenses, the cabinet shall not approve a change of location that is outside the boundaries of the medicinal cannabis region for which the license was issued or that otherwise is not in compliance with the location restrictions contained in Section 3(3) of this administrative regulation.

Section 10. Request to Sell Cannabis Business License.

(1) A licensee desiring to sell its cannabis business license shall submit to the cabinet by electronic mail to kymedcanreporting@ky.gov a written request for approval of the sale . The sale of a cannabis business license shall not occur unless the cabinet approves the sale in writing. The cabinet shall review the request and notify the licensee in writing whether the proposed sale is approved or denied. The cabinet shall consider the initial license application requirements for a cannabis business contained in KRS Chapter 218B and 915 KAR 1:010, and any other factors that the cabinet deems relevant in making its determination on the request.

(2) A written request to approve a license sale shall include the sale price, the reason(s) for requesting the sale, and information about the proposed purchaser, including:

(a) All information and documentation required to be submitted by a cannabis business as part of the initial license application process to show the proposed purchaser would be eligible for entry into a license lottery conducted according to this administrative regulation;

(b) Signed attestations from the proposed purchaser that are required as part of the initial license application process;

(d) A notarized affidavit from the proposed purchaser swearing or affirming that all information and documentation provided to the cabinet along with the request is true and correct, and an acknowledgement that any false statement made to the cabinet as part of the proposed sale process is punishable under the applicable provisions of KRS 523.100.

(3) The cabinet shall approve a licensee's sale of a license if the proposed purchaser and any new location or facilities meet the requirements of KRS Chapter 218B and 915 KAR Chapter 1.

(4) The cabinet shall deny a licensee's sale of a license to any proposed purchaser who currently holds a license in a different cannabis business category than that being offered for sale (such as the proposed purchaser seeks to purchase a dispensary license while currently licensed as a tier I cultivator), except that a cultivator may sell its license to another licensed cultivator in the same or different cultivator tier (such as the proposed purchaser may purchase a tier II cultivator license while currently licensed as a tier I cultivator). Cultivators may hold licenses in more than one (1) cultivator tier at any given time if each license contains a separate and distinct physical address where cultivator conducts licensed cannabis activities and the licensee is otherwise in compliance with the requirements of KRS Chapter 218B and 915 KAR Chapter 1.

Section 11. Issuance of Additional Cannabis Business Licenses.

(1) Beginning January 1, 2025, the cabinet shall, on a quarterly basis, review the need for issuance of new licenses in each cannabis business category.

(2) In making its determination whether to issue new licenses, the cabinet may consider:

(a) The population of the Commonwealth;

(b) The number of active cardholders;

(d) Market supply and demand;

(e) Geographic distribution of dispensaries and other cannabis businesses;

(f) Workforce development opportunities; and

(g) Any other factors that the cabinet deems relevant to its analysis.

(3) If the cabinet determines there exists a need for additional cannabis business licenses in the Commonwealth, the cabinet shall issue a notice documenting the basis for this determination, including a list of the factors it considered to arrive at that determination.

(4) The cabinet shall publish on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov, the notice required by this Section as well as a notice of initial license application availability. This notice shall provide the timeframe during which initial license applications shall be accepted by the cabinet and the category and number of cannabis business licenses available for distribution at the close of the application period. Applicants for new cannabis business licenses shall adhere to the requirements of 915 KAR 1:010 regarding initial license applications and follow the initial license application instructions. The process for issuing new licenses shall comply with the requirements of this administrative regulation.

Section 12. Penalties and Sanctions.

(1) In addition to any other penalty imposed by law for violations of KRS Chapter 218B and 915 KAR Chapter 1, the cabinet may take one (1) or more of the following actions:

(a) Suspend or revoke a license if:

The licensee or any of its agents commit multiple violations or a serious violation of the requirements of KRS Chapter 218B and 915 KAR Chapter 1;
The licensee or any of its agents fail to maintain effective control against diversion of medicinal cannabis from its facility or under its control;
The licensee or any of its agents violate a provision of other state or local laws regarding the operation of its cannabis business;
The licensee or any of its agents engage in conduct, or an event occurs, that would have disqualified the cannabis business from being issued a license or having its license renewed; or
The licensee submitted false or misleading information on any application submitted to the cabinet.

(b) Impose a civil fine of not more than $10,000 for each violation and an additional fine of not more than $1,000 for each day of the continuing violation. In determining the amount of each fine, the cabinet shall consider:

The seriousness of the violation;
The potential harm resulting from the violation to cardholders or the general public;
The willfulness of the violation;
Previous violations, if any, by the licensee being assessed;
The economic benefit to the licensee being assessed for failing to comply with the requirements of KRS Chapter 218B, 915 KAR Chapter 1, or an order issued by the cabinet; and
The economic determent to the licensee.

(c) Issue a cease-and-desist order to immediately stop or restrict the operations of a licensee to protect the public's health, safety, and welfare. The following applies to issuing a cease-and-desist order:

An order may include a requirement that a licensee cease or restrict some or all of its operations. In addition, the order may prohibit the use of some or all of the medicinal cannabis grown, processed, or to be sold by the licensee;
An order may be issued by an authorized agent of the cabinet immediately upon the completion of an inspection or investigation if the agent observes or suspects an operational failure or determines that the conditions will likely create a diversion of medicinal cannabis, contamination of medicinal cannabis, or a risk to cardholders or the general public;
An order may be issued by an authorized agent of the cabinet in circumstances where a licensee fails to provide timely notice of closure of a cannabis business location in accordance with Section 7 of this administrative regulation and the cabinet suspects the imminent closure of the cannabis business shall likely create a diversion of medicinal cannabis or a risk to cardholders or the general public;
An order may include:

a. An immediate evacuation of the site and facility, and the sealing of the entrances to the facility;

b. A quarantine of some or all of the medicinal cannabis found at the facility; and

c. The suspension of the sale or shipment of some or all of the medicinal cannabis found at the facility.

(d) Issue a written warning if the cabinet determines that either:

The public interest shall be adequately served under the circumstances by the issuance of the warning; or
The violation does not threaten the safety or health of cardholders or the general public, and the licensee shall take immediate action to remedy the violation.

(e) Require a licensee develop and adhere to a corrective action plan approved by the cabinet. The cabinet shall monitor compliance with the corrective action plan. Failure to comply with the corrective action plan may result in the cabinet taking additional action under the applicable provisions of this section as it deems appropriate.

(2) A person who aids, abets, counsels, induces, procures, or causes another person to violate KRS Chapter 218B or 915 KAR Chapter 1, or an order issued by the cabinet, shall be subject to the civil penalties provided for under this section.

(3) Before the cabinet may revoke or suspend a license, the cabinet shall provide the licensee with written notice specifying the nature of the alleged violation(s) and allow the licensee an opportunity to appear and be heard pursuant to KRS Chapter 13B. Any resulting hearing shall be conducted in compliance with the requirements of KRS Chapter 13B.

(4) The cabinet shall provide a licensee with written notice of imposition of a civil fine, order of restitution, cease-and-desist order, written warning, or corrective action plan by certified mail to the address on the license. The licensee may, within thirty (30) calendar days after the date of the mailing of the cabinet's notice, file a written request for an administrative hearing regarding the action taken. The hearing shall be conducted in compliance with the requirements of KRS Chapter 13B.

Section 13. Technical Advisories.

(1) The cabinet may issue technical advisories by memorandum to assist licensees in complying with the KRS Chapter 218B and 915 KAR Chapter 1.

(2) Technical advisories shall not have the force of law or regulation, but shall provide guidance on the cabinet's interpretation of, and how a licensee may maintain compliance with, KRS Chapter 218B and 915 KAR Chapter 1.

(3) Notice of the availability of a technical advisory shall be published on the Web site of the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

Section 14. Minimal Performance Standards for Biennial Accreditation.

(1) As part of the license renewal process, licensees shall meet the minimum performance standards established in 915 KAR 1:010, Section 6 to be approved for a renewal license.

(2) If a licensee successfully meets the minimum performance standards established in 915 KAR 1:010, Section 6 over a two (2) year period, the cabinet shall recognize the licensee as an accredited cannabis business in the Commonwealth.

(3) The recognition provided under this section shall expire two (2) years after the date of issuance, and shall be renewed if the licensee continues to:

(a) Operate in the Commonwealth as of the expiration date; and

(b) Meet the minimum performance standards established in 915 KAR 1:010, Section 6.

History

RELATES TO: KRS Chapter 13B, Chapter 218B, 304.39-110, 523.100
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing procedures for the issuance, renewal, suspension, and revocation of cannabis business licenses. This administrative regulation establishes those procedures.
History: 50 Ky.R. 2554; 51 Ky.R. 700, 925; eff. 11-18-2024.

915 KAR 1:030 Cultivator {#sec-915-kar-1-030 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:030}

Section 1. General Requirements.

(1) A person or entity shall not engage in the business of planting, growing, cultivating, raising, harvesting, trimming, storing, testing, packaging, labeling, transferring, transporting, selling, or offering to sell medicinal cannabis seeds, seedlings, tissue cultures, clones not taller than eight (8) inches, medicinal cannabis plants, medicinal cannabis, or medicinal cannabis products to a cannabis business without first being issued a license by the cabinet. A cultivator shall not sell or transfer, or allow the sale or transfer, of medicinal cannabis seeds, seedlings, tissue cultures, clones not taller than eight (8) inches, medicinal cannabis plants, medicinal cannabis, or medicinal cannabis products to any person or entity in the Commonwealth who does not hold a cannabis business license issued by the cabinet.

(2) A cultivator shall:

(a) Conduct cultivation activities in an enclosed, locked facility in accordance with KRS 218B.095(5);

(b) Conduct a criminal background check into the criminal history of each person seeking to become a principal officer, board member, agent, volunteer, or employee before that person begins work and shall retain records of these background checks for five (5) years and provide same to the cabinet during subsequent inspections or upon request; and

(c) Comply with all applicable requirements of KRS Chapter 218B, specifically KRS 218B.095 and 218B.105, and 915 KAR Chapter 1.

(3) A cultivator shall not:

(a) Employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age; or

(b) Sell or transfer, or allow the sale or transfer, of medicinal cannabis seeds, seedlings, medicinal cannabis plants, medicinal cannabis, or medicinal cannabis products to any person or entity in the Commonwealth who does not hold a cannabis business license issued by the cabinet.

(4) The qualifications that a cultivator shall meet to receive a license are continuing qualifications to maintain the license throughout the licensure period.

Section 2. Plans of Operation.

(1) Prior to its first day of cultivation activities in the Commonwealth, a cultivator shall establish standard operating procedures for:

(a) Employment policies and procedures;

(b) Security, including:

Staff identification measures, including use of employee identification badges;
Monitoring of attendance of staff and visitors;
Alarm systems;
Video surveillance;
Monitoring and tracking inventory, including use of the Commonwealth's electronic monitoring system and seed to sale tracking system established pursuant to KRS 218B.140;
Personnel security;
Transportation of medicinal cannabis and how to properly secure medicinal cannabis in the event of a traffic collision or transport vehicle malfunction;
Cash management and anti-fraud procedures;
Measures to prevent loitering, which shall include signage; and
Storage of seeds, seedlings, tissue cultures, clones not taller than eight (8) inches, medicinal cannabis plants, medicinal cannabis, or medicinal cannabis products;

(c) The process for receiving, growing, cultivating, harvesting, handling, packaging, labeling, storing, transporting, and disposing of seeds, seedlings, tissue cultures, clones not taller than eight (8) inches, medicinal cannabis plants, medicinal cannabis, or medicinal cannabis products and a process for handling, tracking, transporting, storing, and disposing of medicinal cannabis waste;

(d) Workplace safety, including conducting safety checks;

(e) Contamination;

(f) Maintenance, cleaning, and sanitation of equipment used to grow and cultivate medicinal cannabis;

(g) Maintenance and sanitation of the cultivator's facility;

(h) Application of pesticides, fertilizers, and herbicides to medicinal cannabis at any point during the growing, cultivating, and harvesting processes;

(i) Proper handling and storage of any chemical or substance used in growing medicinal cannabis;

(j) Logging the use of all pesticides and chemical applications applied to medicinal cannabis and medicinal cannabis products;

(k) Quality control, including strict regulation of the amount of delta-9 tetrahydrocannabinol content in each medicinal cannabis harvest batch, proper labeling, and minimization of medicinal cannabis contamination;

(l) Recordkeeping and inventory control;

(m) Investigation of complaints and potential adverse events received from other cannabis businesses, cardholders, or medicinal cannabis practitioners regarding the cultivator's operations;

(n) Preventing unlawful diversion of medicinal cannabis;

(o) A recall plan; and

(p) Any other standard operating procedures required for all cannabis businesses in KRS Chapter 218B and 915 KAR Chapter 1.

(2) A cultivator shall make its standard operation procedures available to the cabinet upon request and during any inspection of the cultivator's site and facility.

Section 3. Cultivator Facilities.

(1) A cultivator shall only plant, grow, cultivate, and harvest medicinal cannabis in an enclosed, locked facility on the specific site licensed by the cabinet and identified on its license issued by the cabinet. A cultivator shall not grow medicinal cannabis directly in the ground.

(2) All cultivation activities, excluding disposal, destruction, or transport of medicinal cannabis, shall take place within a building or secure structure that:

(a) Has a foundation, slab, or equivalent base with a complete roof enclosure supported by connecting walls, constructed of solid materials extending from the ground to the roof;

(b) Is secure against unauthorized entry;

(d) Restricts access to only authorized personnel to limited access areas identified with signage and daily records of entry and exit;

(e) Contains adequate plumbing to carry sufficient quantities of water to locations throughout the facility and convey any sewage and waste from the facility without cross contamination of potable water and waste;

(f) Stores toxic cleaning compounds, sanitizing agents, pesticides, fertilizers, and herbicides in a manner that is in accordance with applicable local, state, and federal laws and regulations;

(g) Maintains proper ventilation;

(h) Maintains pest control;

(i) Maintains adequate indoor and exterior lighting to facilitate video surveillance at all times;

(j) Maintains adequate on-site parking for employees, agents, visitors, transporters of medicinal cannabis, or cabinet staff; and

(k) Meets all applicable state and local building codes and specifications.

(3) A cultivator shall clearly mark all limited access areas on its premises with proper signage. All areas of ingress and egress to a limited access area shall be clearly identified by the posting of a sign which shall be not less than twelve (12) inches wide and twelve (12) inches long, composed of letters not less than one-half (1/2) inch in height, which shall state: "Do Not Enter. Limited Access Area. Access Limited to Authorized Personnel and Escorted Visitors."

(4) A cultivator shall have a secure area for the loading and unloading of medicinal cannabis seeds, seedlings, medicinal cannabis plants, and medicinal cannabis into and from a transport vehicle.

(5) If a cultivator intends to conduct medicinal cannabis cultivation and hemp cultivation at the same licensed location, the cultivator shall, prior to its first day of medicinal cannabis cultivation activities, provide the cabinet with:

(a) Proof that the cultivator is permitted to operate a hemp business by the appropriate permitting authority and is in good standing;

(b) A written plan for keeping strictly separated all medicinal cannabis cultivation activities from hemp cultivation activities; and

(c) A site map or blueprint showing which portions of the facility are designated for medicinal cannabis cultivation activities and which portions are designated for hemp cultivation activities.

(6) Pursuant to KRS 218B.100(1), a cannabis business that co-locates with a hemp business shall be subject to reasonable inspection by the cabinet and the cabinet may inspect the entire facility as part of an inspection.

Section 4. Inventory.

(1) A cultivator shall, within twenty-four (24) hours of receipt, record in the Commonwealth's designated electronic monitoring system and seed to sale tracking system each medicinal cannabis seed, seedling, tissue culture, clone, or plant that it acquires.

(2) A cultivator shall only grow medicinal cannabis plants from seeds, tissue cultures, clones not taller than eight (8) inches, and seedlings located physically in its facility.

(3) Canopy. A cultivator shall not exceed the indoor growth area specified in KRS 218B.105(3) for its respective cultivator tier. The surface area of the plant canopy shall be calculated in square feet. Measurement shall include all of the area within the boundaries where the cultivation of medicinal cannabis plants occurs. If a tiered or shelving system is used in the cultivation area, the surface of each tier or shelf shall be included in the calculation. Calculation of the area of the plant canopy shall not include square footage within a cultivator's enclosed, locked facility used for the storage of seeds, seedlings, tissue cultures, or clones not taller than eight (8) inches, supplies, pesticides, fertilizers, or other products as well as square footage used for quarantine, office space, or other non-cultivation activities.

Section 5. Employees Records and Identification.

(1) A cultivator shall keep an individual employment record for all employees, including:

(a) Full legal name;

(b) Detailed job description;

(d) Record of all training received or acquired by the employee;

(e) Dates of employment;

(f) Records of days and hours worked; and

(g) Any disciplinary actions taken by the cultivator.

(2) Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee's last date of employment with the cultivator.

(3) A cultivator shall create an identification badge for each employee, agent, or volunteer. The badge shall be conspicuously worn by employees, agents, or volunteers at all times that they are on the licensed premises or during transport of medicinal cannabis. The badge shall contain:

(a) The individual's name, photo, employee identification number, and the license number of the cultivator;

(b) A phone number and email address for the cultivator; and

Section 6. Visitors to Cultivator Facilities.

(1) A cultivator site and facility shall not be open to the general public.

(2) When admitting a visitor to its site and facility, a cultivator shall :

(a) Require the visitor to sign a visitor log upon entering and leaving the facility;

(b) Check the visitor's government-issued identification to verify the visitor's age and that the name on the identification provided matches the name in the visitor log;

(d) Escort the visitor while the visitor remains on the site or in the facility; and

(e) Ensure that the visitor does not touch any medicinal cannabis plant or medicinal cannabis located in a limited access area.

(3) A person under the age of eighteen (18) shall not be permitted to enter a cultivator's site or facility. A person who is at least eighteen (18) years of age may enter and remain on the cultivator's premises if that person is present to perform contract work, including electrical, plumbing, or security maintenance, which does not involve handling medicinal cannabis, or is a government employee and is at the cannabis business in the course of his or her official duties.

(4) A cultivator shall post a sign in a conspicuous location at each entrance of its site and facility that states "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER." The letters on the signs shall be at minimum one-half (1/2) inch in height.

(5) The cultivator shall maintain the visitor log required under this section for five (5) years and make the visitor log available to the cabinet, law enforcement, and other federal or state government officials upon request to perform the government officials' functions and duties. The visitor log shall include the date, the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit.

(6) This section shall not limit the right of the cabinet or its authorized agents, or other federal, state, or local government officials from entering any area of a cultivator's site and facility if necessary to perform the governmental officials' functions and duties.

(7) A principal officer, board member, agent, financial backer, employee, or volunteer of a cultivator shall not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.

Section 7. Security and Surveillance.

(1) A cultivator shall have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry and to prevent and detect an adverse loss. The security and surveillance systems shall include:

(a) A professionally monitored security alarm system that includes:

Coverage of all facility entrances and exits; rooms with exterior windows, exterior walls, roof hatches, or skylights; storage rooms, including those that contain medicinal cannabis and safes; and the perimeter of the facility;
An audible security alarm system signal, known as a panic alarm, generated by the manual activation of a device intended to signal a life-threatening or emergency situation requiring law enforcement response;
A silent alarm signal, known as a holdup alarm, generated by the manual activation of a device intended to signal a robbery in progress;
A failure notification system that provides an audible, text, or visual notification of any failure in the systems. The failure notification system shall provide by telephone, e-mail, or text message an alert to a designated security person within the facility within five (5) minutes after the failure;
Smoke and fire alarms;
Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to ensure all access doors are not solely controlled by an electronic access panel to prevent locks from becoming released during a power outage; and
Motion detectors for exterior lighting; and

(b) A professionally monitored security surveillance system that is operational twenty-four (24) hours a day, seven (7) days a week, and records all activity in images capable of clearly revealing facial detail. The security and surveillance system shall include:

Fixed camera placement that allows for a clear image of all individuals and activities in and around:

a. All limited access areas;

b. A room or area containing a security alarm and surveillance system storage device or equipment;

c. Entrances to and exits from the facility. Entrances and exits shall be recorded from both indoor and outdoor vantage points;

d. Rooms with exterior windows, exterior walls, roof hatches, or skylights and storage rooms, including those that may contain medicinal cannabis and safes and excluding restrooms; and

e. Twenty (20) feet from the exterior of the perimeter of the facility;

Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to operate under the normal lighting conditions of each area under surveillance;
The ability to immediately produce a clear, color, still photograph in a digital format that is easily accessible;
The ability to clearly and accurately display the date and time. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture;
The ability to record all images captured by each surveillance camera in a format that shall be easily accessed for a minimum of sixty (60) days, unless otherwise required for investigative or litigation purposes. The recordings shall be kept:

a. At the cultivator's facility:

(i) In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and

(ii) In a limited access area or other room to which access is limited to authorized individuals; or

b. At a secure location other than the location of the cultivator's facility if approved by the cabinet; and

The ability to easily export video recordings and still photographs requested by the cabinet, law enforcement, and other federal or state government officials and provide same in a standard file format that is easily accessible.

(2) Regarding inspection, servicing, alteration of, and any upgrade to, the security alarm and surveillance systems:

(a) The systems shall be inspected and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor;

(b) A cultivator shall conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security alarm and surveillance systems are made for the proper operation of the systems. No more than thirty (30) calendar days shall lapse between the inspections required under this paragraph;

(c) A cultivator shall retain at the facility, for at least five (5) years, records of all inspections, servicing, alterations, and upgrades performed on the security alarm and surveillance systems and shall make the records available to the cabinet and its authorized agents within two (2) business days following a request; and

(d) If there is a mechanical malfunction of the security alarm or surveillance system that a cultivator anticipates shall exceed an eight (8) hour period, the cultivator shall notify the cabinet immediately by electronic mail to kymedcanreporting@ky.gov and, with cabinet approval, provide alternative security measures that may include closure of the facility.

(3) Regarding records retention, a cultivator shall:

(a) Have a secure electronic back-up system for all electronic records;

(b) Within three (3) business days following a request for records under this paragraph, provide up to four (4) screen captures of an unaltered copy of a video surveillance recording to the cabinet or its authorized agents, law enforcement, or other federal, state, or local government officials if necessary to perform the governmental officials' functions and duties; and

(c) If it has been notified in writing by the cabinet or its authorized agents, law enforcement, or other federal, state, or local government officials of a pending criminal or administrative investigation for which a recording may contain relevant information, retain an unaltered copy of the recording for two (2) years or until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the cultivator that it is not necessary to retain the recording, whichever is later.

(4) During all non-working hours, all entrances to and exits from the cultivator's facility shall be securely locked.

(5) A cultivator shall install lighting to ensure proper surveillance inside and outside of the facility.

(6) A cultivator shall limit access to a room containing the equipment operating the security alarm and surveillance monitoring systems to:

(a) Persons who are essential to maintaining security and surveillance operations;

(b) Federal, state, and local law enforcement;

(d) The cabinet or its authorized agents; and

(e) Other persons with the prior written approval of the cabinet.

(7) A cultivator shall make available to the cabinet or its authorized agents, upon request, a current list of authorized employees and service employees or contractors who have access to areas containing the equipment operating the security alarm and surveillance monitoring systems and place a copy of this list on or next to the doors that access those areas.

(8) A cultivator shall keep rooms housing the equipment operating the security alarm and surveillance monitoring systems locked at all times and shall not use these rooms for any other purpose or function.

Section 8. Requirements for Cultivating and Growing Medicinal Cannabis.

(1) A cultivator who uses a pesticide on medicinal cannabis shall be certified to apply pesticides by the Kentucky Department of Agriculture pursuant to KRS Chapter 217B.

(2) A cultivator who is certified to apply pesticides by the Kentucky Department of Agriculture shall not use, or be eligible to use, a Category 10 license to apply pesticides to medicinal cannabis in violation of the product label.

(3) A cultivator shall not use any pesticide in violation of the product label.

(4) A cultivator who uses a pesticide on growth medium used for multiple medicinal cannabis cultivation cycles shall comply with the longest of any planting restriction interval on the product label prior to reusing the growth medium.

(5) The cabinet may perform pesticide testing on a random basis or if its authorized agents have reason to believe that a pesticide may have been applied to medicinal cannabis in violation of the product label.

(6) Medicinal cannabis seeds, seedlings, tissue cultures, clones, plants, and materials bearing pesticide residue in violation of the label or testing standards established by the cabinet shall be subject to forfeiture or destruction without compensation.

(7) The cabinet shall publish a list of approved pesticides and any other chemical applications for use in growing and cultivating medicinal cannabis on the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov. This list shall be reviewed and updated annually by the cabinet.

(8) A cultivator shall maintain a log of the use of all pesticides and any other chemical applications applied to medicinal cannabis and medicinal cannabis products for a minimum of five (5) years, including:

(a) The date of application;

(b) The name of the individual making the application;

(d) The section, including the square footage, that received the application;

(e) The amount of product that was applied; and

(f) A copy of the label of the product that was applied.

(9) A cultivator shall:

(a) Use appropriate nutrient practices;

(b) Use a fertilizer or hydroponic solution of a type, formulation, and at a rate to support healthy growth of plants; and

(10) A cultivator shall perform visual inspections of growing medicinal cannabis plants and harvested medicinal cannabis plant material to ensure there are no visible insects, mold, mildew, pests, rot, grey or black plant material, or inorganic material, including plastic, glass, and metal shavings.

(11) A cultivator shall have a separate and secure area for temporary storage of medicinal cannabis that is awaiting disposal by the cultivator.

(12) A cultivator shall establish procedures to monitor, record, and regulate:

(a) Temperature;

(b) Humidity;

(d) Lighting; and

(e) Water supply.

Section 9. Electronic Monitoring System and Seed to Sale Tracking System.

(1) A cultivator shall use the electronic monitoring system and seed to sale tracking system prescribed by the cabinet containing the requirements in KRS Chapter 218B, specifically KRS 218B.140, and in accordance with written instructions provided by the cabinet. A cultivator shall ensure its inventory recorded in the electronic monitoring system and seed to sale tracking system is accurate in real-time.

(2) A cultivator shall establish inventory controls and procedures to conduct inventory reviews at its facility, including that a cultivator shall:

(a) Prepare monthly physical inventory reports that include any necessary adjustments and the reason(s) for an adjustment and that demonstrates the physical inventory reconciles with the inventory recorded in the Commonwealth's designated electronic monitoring system and seed to sale tracking system, including any medicinal cannabis that has been or is in the process of being destroyed. No more than thirty (30) calendar days shall lapse between the preparation of a report required under this paragraph; and

(b) Create and maintain a written or electronic record of each inventory conducted under this section that includes the date of the inventory, a summary of the inventory findings, and the employee identification numbers and titles or positions of the individuals who conducted the inventory.

Section 10. Equipment, operation, and maintenance.

(1) A cultivator shall have a written process to maintain the sanitation and operation of equipment that comes into contact with medicinal cannabis to prevent contamination. The cultivator shall provide a copy of the written process to the cabinet upon request.

(2) As part of the written process required under this section, a cultivator shall:

(a) Routinely calibrate, check, and inspect automatic, mechanical, or electronic equipment as well as any scales, balances, or other measurement devices used in the cultivator's operations to ensure accuracy; and

(b) Maintain an accurate log recording the:

Maintenance of equipment;
Cleaning of equipment; and
Calibration of equipment.

Section 11. Sanitation and Safety in a Cultivator Facility.

(1) A cultivator shall maintain its site and facility in a sanitary condition to limit the potential for contamination of the medicinal cannabis grown in the facility, including that:

(a) Equipment and surfaces, including floors, counters, walls, and ceilings, shall be cleaned and sanitized as frequently as necessary to protect against contamination using a sanitizing agent registered by the United States Environmental Protection Agency in accordance with the instructions printed on the label. All equipment and utensils used by a cultivator shall be capable of being adequately cleaned;

(b) Trash shall be properly and routinely removed to prevent pest infestation;

(d) Equipment, counters, and surfaces used for packaging and labeling of medicinal cannabis shall be food grade quality;

(e) Adequate protection against pests shall be provided through the use of integrated pest management practices and techniques that identify and manage plant pathogens and pest problems; and

(f) Toxic cleaning compounds, sanitizing agents, pesticides, herbicides, and other chemicals shall be labeled and stored in a manner that prevents contamination of seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, and medicinal cannabis.

(2) All employees and volunteers shall conform to sanitary practices while on duty, which includes:

(a) Maintaining adequate personal cleanliness;

(b) Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated;

(c) Wearing proper clothing, including gloves, hair nets, headbands, caps, beard covers, or other effective hair restraints where appropriate;

(d) Removing all unsecured jewelry and other objects that might fall into medicinal cannabis, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which medicinal cannabis is manipulated by hand. If hand jewelry cannot be removed, it shall be covered by material that can be maintained in an intact, clean, and sanitary condition and which effectively protects the medicinal cannabis from contamination by these objects;

(e) Storing clothing or other personal belongings in areas other than where medicinal cannabis is exposed or where equipment is cleaned;

(f) Eating food, chewing gum, drinking beverages, or using vaping or tobacco products be confined to areas other than where medicinal cannabis may be exposed or where equipment is cleaned; and

(g) Taking any other necessary precautions to protect against contamination of medicinal cannabis with microorganisms or foreign substances including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin.

(3) A cultivator shall:

(a) Provide its employees, volunteers, and visitors with adequate and convenient hand-washing facilities furnished with running water at a temperature suitable for sanitizing hands. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable drying devices shall also be provided;

(b) Provide its employees, volunteers, and visitors with adequate, readily accessible restrooms that are maintained in a sanitary condition and in good repair;

(c) Ensure that its facility is provided with a water supply sufficient for its operations, which shall be derived from a source that is a public water system, or a nonpublic system that is capable of providing a safe, potable, and adequate supply of water to meet the operational needs of the facility; and

(d) Comply with all other applicable federal, state, and local building code requirements and occupational safety and health requirements.

Section 12. Storage Requirements.

(1) A cultivator shall have separate locked limited access areas for storage of seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, and medicinal cannabis that are expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, and medicinal cannabis are destroyed or otherwise disposed of as required under Section 15 of this administrative regulation.

(2) A cultivator shall maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.

Section 13. Management and Disposal of Medicinal Cannabis Waste.

(1) A cultivator shall dispose of undesired, excess, unauthorized, obsolete, adulterated, misbranded, or deteriorated medicinal cannabis in a manner as to render the medicinal cannabis unusable. A cultivator shall record medicinal cannabis waste as required in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(2) Medicinal cannabis that is rendered unusable shall be discarded into a dumpster with commercial grade locks or other approved, locked container for removal from the facility by a waste removal company selected by the cultivator, except that ashes resulting from the controlled incineration of medicinal cannabis may be placed in an unlocked dumpster or composted in a secured area at the cultivation site for future use at the facility. Medicinal cannabis shall be rendered unusable by:

(a) Controlled incineration; or

(b) Grinding and incorporating the medicinal cannabis with one (1) or more of the non-consumable, solid wastes listed below so that the resulting mixture is majority non-cannabis waste:

Paper waste;
Cardboard waste;
Food waste;
Yard or garden waste;
Grease or other compostable oil waste; or
Soil or other used growth media.

(3) The disposal of medicinal cannabis shall be performed under video surveillance from the time the destruction begins to when it is placed in a locked dumpster or other approved, locked container and removed from the cultivator's site and facility.

(4) A minimum of two (2) employees shall oversee the disposal of medicinal cannabis and the cultivator shall maintain and make available a separate record of every disposal indicating:

(a) The date and time of disposal;

(b) The manner of disposal;

(d) The reasoning for and description of the disposal;

(e) The names, employee identification numbers, and signatures of the employees overseeing the disposal of the medicinal cannabis; and

(f) If the disposal contains medicinal cannabis that was prepared for sale to a dispensary or processor, the harvest batch number, strain, volume, weight, and number of units if applicable of the medicinal cannabis being disposed of.

(5) The disposal of other waste from the cultivator that does not include medicinal cannabis, including hazardous waste and liquid waste, shall be performed in a manner consistent with applicable federal, state, and local requirements.

Section 14. Requirements for Cultivators to Deliver Raw Plant Material to Dispensaries for Sale.

(1) A cultivator that delivers medicinal cannabis to licensed dispensaries for sale to cardholders shall comply with the requirements of KRS Chapter 218B and 915 KAR Chapter 1, including 915 KAR 1:080, 915 KAR 1:100, and 915 KAR 1:110.

(2) A cultivator that delivers medicinal cannabis to a licensed dispensary for sale to cardholders shall not:

(a) Deliver, transfer, or sell raw plant material to a dispensary for more than fair market value;

(b) Supply a dispensary with more than the amount of raw plant material reasonably required by a dispensary to maintain an inventory sufficient for normal retail operations; and

(c) Deliver, transfer, or sell raw plant material to a dispensary with a delta-9 tetrahydrocannabinol content of more than thirty-five (35) percent.

(3) Any raw plant material to be sold as a medicinal cannabis product by a cultivator to a dispensary shall:

(a) Be free of seeds and extraneous stems;

(b) Be free of dirt, sand, debris, or other foreign matter; and

(c) Not contain a level of pesticides, herbicides, poisons, toxins, mold, mildew, insects, bacteria, or any other chemical substance higher than the levels established in the standards for testing within 915 KAR 1:110.

(4) A cultivator shall prepare raw plant material for sale to dispensaries in a safe and sanitary manner, including that:

(a) Raw plant material shall be handled on food grade stainless steel benches or tables;

(b) Proper sanitation shall be maintained;

(d) Prior to packaging, the raw plant material shall have passed all required safety compliance facility tests established in 915 KAR 1:110.

(5) In addition to other packaging and labeling requirements established in 915 KAR 1:100, all raw plant material packaged and sold by a cultivator in the Commonwealth shall be marked or labeled as "NOT INTENDED FOR CONSUMPTION BY SMOKING."

(6) Except for transfer of samples to a safety compliance facility for testing, no medicinal cannabis shall be sold or transferred to another cannabis business until all required testing is complete and the representative sample passed inspection. Cultivators shall not sell medicinal cannabis directly to cardholders.

Section 15. Complaints About or Recall of Medicinal Cannabis Products.

(1) A cannabis business shall immediately notify the cabinet by electronic mail to kymedcanreporting@ky.gov, as well as the cultivator from which it obtained any medicinal cannabis in question, upon becoming aware of any defects or quality issues with the medicinal cannabis or any complaint made to the cannabis business by another cannabis business, a cardholder, or medicinal cannabis practitioner who reports an adverse event from using medicinal cannabis purchased by the cannabis business from the cultivator. A cultivator shall investigate the report and shall immediately investigate a complaint to determine if a voluntary or mandatory recall of seeds, seedlings, medicinal cannabis plants, postharvest plant material, or medicinal cannabis is necessary or if any further action is required.

(a) If a cultivator determines that further action is not required, the cultivator shall notify the cabinet of its decision and, within twenty-four (24) hours, submit a written report to the cabinet stating its rationale for not taking further action. The cabinet shall review the written report and consult with the cultivator as needed. If the cabinet disagrees with the cultivator's decision, the cabinet shall take all necessary steps allowable under KRS Chapter 218B and 915 KAR Chapter 1 to ensure public health and safety, including issuing a cease-and-desist order to pause the sale and distribution of the medicinal cannabis at issue until resolution of the matter.

(b) If a cultivator determines that further action is required, the cultivator shall initiate a voluntary or mandatory recall in accordance with the requirements of this section.

(2) Voluntary recalls. If a cultivator voluntarily initiates a recall, the cultivator shall recall seeds, seedlings, medicinal cannabis plants, postharvest plant material, or medicinal cannabis from the market at its discretion for reasons that shall not pose a risk to public health and safety and shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov at the time the cultivator begins the recall.

(3) Mandatory recalls. If a cultivator discovers that a condition relating to the seeds, seedlings, medicinal cannabis plants, postharvest plant material, or medicinal cannabis grown at its facility poses a risk to public health and safety, the cultivator shall:

(a) Immediately notify the cabinet by phone and electronic mail to kymedcanreporting@ky.gov; and

(b) Secure, isolate, and prevent the distribution of the seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis that may have been affected by the condition and remains in its possession. The cultivator shall not dispose of affected seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis prior to notifying the cabinet and coordinating the disposal with the cabinet.

(4) If a cultivator fails to cooperate with the cabinet in a recall, or fails to immediately notify the cabinet of a need for a recall under this section, the cabinet may seek a cease-and-desist order and the cultivator may be subject to any other penalties or sanctions provided for in KRS Chapter 218B and 915 KAR Chapter 1:020.

(5) A cultivator's recall plan as required under this administrative regulation shall include:

(a) Designation of one (1) or more employees to serve as the recall coordinator(s). A recall coordinator shall be responsible for, among other duties, accepting the recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis;

(b) Procedures for identifying and isolating the affected seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis to prevent or minimize its distribution to cardholders and other cannabis businesses;

(c) Procedures to retrieve and dispose of the affected seeds, seedlings, medicinal cannabis plants, postharvest plant material, or medicinal cannabis;

(d) A communications plan to notify those affected by the recall, including:

The manner in which the cultivator shall notify other cannabis businesses in possession of seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis subject to the recall; and
The use of press releases and other appropriate notifications to ensure that cardholders are notified of the recall if affected medicinal cannabis was dispensed to cardholders.

(e) Procedures for notifying the cabinet; and

(f) Procedures for entering information relating to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(6) A cultivator shall follow the procedures outlined in its recall plan unless the cultivator obtains prior written approval of the cabinet or the cabinet notifies the cultivator in writing to perform other procedures. A cultivator shall conduct recall procedures in a manner that maximizes the recall of affected seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, and medicinal cannabis and minimizes risks to public health and safety.

(7) A cultivator shall coordinate the disposal of recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, and medicinal cannabis with the cabinet. The cabinet or its authorized agents may oversee the disposal to ensure that the recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, and medicinal cannabis are disposed of in a manner that shall not pose a risk to public health and safety.

(8) The cultivator shall enter information relevant to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system as part of the inventory, which shall include:

(a) The total amount of recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, and medicinal cannabis, including types and harvest batches, if applicable;

(b) The total amount of recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis returned to the cultivator, including types, forms, and harvest batches, if applicable;

(d) From whom the recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis were received;

(e) The means of transport of the recalled seeds, seedlings, tissue cultures, clones, medical medicinal cannabis plants, postharvest plant material, medicinal cannabis, or medicinal cannabis products;

(f) The reason for the recall;

(g) The number of recalled samples, types, forms, and harvest batches, if applicable, sent to safety compliance facilities, the names and addresses of the safety compliance facilities, the dates of testing, and the results by sample; and

(h) The manner of disposal of the recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, and medicinal cannabis, including:

The names of the individuals overseeing the disposal of the recalled seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis;
The name of the disposal company, if applicable;
The method of disposal;
The date of disposal; and
The amount disposed of by types, forms, and harvest batches, if applicable.

(9) The cabinet may initiate a mandatory recall upon receipt of information that a condition relating to the seeds, seedlings, tissue cultures, clones, medicinal cannabis plants, postharvest plant material, or medicinal cannabis grown or sold by a cultivator poses a risk to public health and safety.

Section 16. Increase of Canopy Limits.

(1) Pursuant to KRS 218B.140(3), if a need for additional medicinal cannabis cultivation in the Commonwealth is demonstrated by cannabis businesses or the cabinet's own analysis, the cabinet may through the promulgation of administrative regulations increase the canopy size limits for cultivators by up to three (3) times the limits established in KRS 218B.105. Any increase in the canopy size limits adopted by the cabinet shall not result in an increase in licensure application or renewal fees established by the cabinet.

(2) In making its determination whether to increase canopy limits for cultivators, the cabinet may consider factors including the population of the Commonwealth, the number of active cardholders, changes to the list of qualifying medical conditions for medicinal cannabis, market supply and demand, the amount of medicinal cannabis being sold by dispensaries, the amount of allowable canopy space being utilized by cultivators, and workforce development opportunities.

Section 17. Duty to Report.

(1) At the time a cultivator submits a license renewal application to the cabinet, a cultivator shall report to the cabinet by electronic mail to kymedcanreporting@ky.gov:

(a) The average amount of allowable canopy space being utilized by the cultivator during the current licensure period. If a cultivator is not utilizing the full amount of allowable canopy space during the current licensure period, the cultivator shall provide a written explanation to the cabinet of the reasons for not utilizing all available canopy space;

(b) The total amount of medicinal cannabis grown during the current licensure period, the total amount of medicinal cannabis sold during the current licensure period and the average price per pound, and total amount of medicinal cannabis sold as finished goods to a dispensary as opposed to sold in bulk to other cannabis businesses for processing; and

(2) A cultivator shall participate in market surveys distributed by the cabinet throughout a licensure period and provide full and complete responses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements and procedures for medicinal cannabis cultivator operations in the Commonwealth. This administrative regulation establishes those requirements and procedures.
History: 50 Ky.R. 1808, 2406; 51 Ky.R. 288; eff. 8-28-2024.

915 KAR 1:040 Processor {#sec-915-kar-1-040 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:040}

Section 1. General Requirements.

(1) A person or entity shall not engage in processing activities in the Commonwealth without first being issued a license by the cabinet. A processor shall not sell or transfer, or allow the sale or transfer, of medicinal cannabis or medicinal cannabis products to any person or entity in the Commonwealth who does not hold a cannabis business license issued by the cabinet.

(2) A processor shall:

(a) Only acquire or purchase raw plant material and medicinal cannabis from a cultivator, processor, or producer in the Commonwealth;

(b) Conduct processing activities in a secure facility on the specific site licensed by the cabinet and identified on its license issued by the cabinet;

(c) Conduct a criminal background check into the criminal history of each person seeking to become a principal officer, board member, agent, volunteer, or employee before that person begins work and shall retain records of these background checks for five (5) years and provide same to the cabinet during subsequent inspections or upon request; and

(d) Comply with all applicable requirements of KRS Chapter 218B, specifically KRS 218B.095 and 218B.115, and 915 KAR Chapter 1.

(3) A processor shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age.

(4) The qualifications that a processor shall meet to receive a license are continuing qualifications to maintain the license throughout the licensure period.

Section 2. Plans of Operation.

(1) Prior to its first day of processing activities in the Commonwealth, a processor shall establish standard operating procedures for:

(a) Employment policies and procedures;

(b) Security, including:

Staff identification measures and use of employee identification badges;
Monitoring of attendance of staff and visitors;
Alarm systems;
Video surveillance;
Monitoring and tracking inventory, including use of the Commonwealth's electronic monitoring system and seed to sale tracking system established pursuant to KRS 218B.140;
Personnel security;
Transportation of medicinal cannabis and how to properly secure medicinal cannabis in the event of a traffic collision or transport vehicle malfunction;
Cash management and anti-fraud procedures;
Measures to prevent loitering, which shall include signage; and
Storage of medicinal cannabis and medicinal cannabis products;

(c) The process for receiving, handling, processing, packaging, labeling, storing, transporting, and disposing of medicinal cannabis and medicinal cannabis products and a process for handling, tracking, transporting, storing, and disposing of medicinal cannabis waste;

(d) Workplace safety, including conducting safety checks;

(e) Contamination;

(f) Maintenance, cleaning, and sanitation of equipment used to process medicinal cannabis;

(g) Maintenance and sanitation of the processor's facility;

(h) Extraction method(s), including standards for processing of raw plant material, refining of medicinal cannabis extracts, and manufacturing of medicinal cannabis products, including safety protocols and equipment;

(i) Proper handling and storage of any solvent, gas, or other chemical or substance used in processing medicinal cannabis;

(j) Quality control, including strict regulation of the amount of delta-9 tetrahydrocannabinol content in each harvest or production batch in accordance with KRS 218B.115(2), proper labeling, and minimization of medicinal cannabis contamination;

(k) Recordkeeping and inventory control;

(l) Investigation of complaints and potential adverse events received from other cannabis businesses, cardholders, or medicinal cannabis practitioners regarding the processor's operations;

(m) Preventing unlawful diversion of medicinal cannabis;

(n) A recall plan; and

(o) Any other standard operating procedures required for all cannabis businesses in KRS Chapter 218B and 915 KAR Chapter 1.

(2) A processor shall make its standard operation procedures available to the cabinet upon request and during any inspection of the processor's site and facility.

Section 3. Processor Facilities.

(1) A processor shall only process medicinal cannabis within a building or secure structure on the specific site licensed by the cabinet and identified on its license issued by the cabinet. The building or secure structure shall:

(a) Have a complete roof enclosure supported by connecting permanent walls, constructed of solid materials extending from the ground to the roof;

(b) Be secure against unauthorized entry;

(d) Have commercial grade door locks on all external doors that are locked at all times;

(e) Restrict access to only authorized personnel to locked and secure areas identified with signage and daily records of entry and exit;

(f) Contain adequate plumbing to carry sufficient quantities of water to locations throughout the facility and convey sewage and waste from the facility without cross contamination of potable water and waste;

(g) Store toxic cleaning compounds, sanitizing agents, solvents, gas, or other chemicals or substances used in processing medicinal cannabis in a manner that is in accordance with applicable local, state, and federal laws and regulations;

(h) Maintain exhaust and ventilation systems to mitigate noxious gasses or other fumes used or created as part of processing activities;

(i) Maintain pest control;

(j) Maintain adequate indoor and exterior lighting to facilitate video surveillance at all times;

(k) Maintain adequate on-site parking for employees, agents, visitors, transporters of medicinal cannabis, or cabinet staff; and

(l) Meet all applicable state and local building codes and specifications.

(2) A processor shall clearly mark all limited access areas on its premises with proper signage. All areas of ingress and egress to a limited access area shall be clearly identified by the posting of a sign which shall be not less than twelve (12) inches wide and twelve (12) inches long, composed of letters not less than one-half (1/2) inch in height, which shall state: "Do Not Enter. Limited Access Area. Access Limited to Authorized Personnel and Escorted Visitors."

(3) A processor shall have a secure area for the loading and unloading of medicinal cannabis into and from a transport vehicle.

(4) On all perimeter doors, a processor shall post signs that shall not be less than twelve (12) inches wide and twelve (12) inches long, composed of letters not less than one-half (1/2) inch in height, that clearly state the type of extraction method or methods used within the facility.

(5) A processor shall enact reasonable measures to ensure medicinal cannabis and medicinal cannabis products are not visible from outside the facility.

(6) If a processor intends to conduct medicinal cannabis processing and hemp processing at the same licensed location, the processor shall, prior to its first day of medicinal cannabis processing activities, provide the cabinet with:

(a) Proof that the processor is permitted to operate a hemp business by the appropriate permitting authority and is in good standing;

(b) A written plan for keeping strictly separated all medicinal cannabis processing activities from hemp processing activities; and

(c) A site map or blueprint showing which portions of the facility are designated for medicinal cannabis processing activities, including storage of medicinal cannabis, and which portions are designated for hemp processing activities, including storage of hemp and hemp products.

(7) Pursuant to KRS 218B.100(1), a cannabis business that co-locates with a hemp business shall be subject to reasonable inspection by the cabinet and the cabinet may inspect the entire facility as part of an inspection.

Section 4. Electronic Monitoring System and Seed to Sale Tracking System.

(1) Except as provided in this section, a processor shall not possess, process, produce, or manufacture:

(a) Raw plant material with a delta-9 tetrahydrocannabinol content of more than thirty-five (35) percent;

(b) Medicinal cannabis products intended for oral consumption as an edible, oil, or tincture with more than ten (10) milligrams of delta-9 tetrahydrocannabinol per serving;

(c) Any medicinal cannabis product not described in this section with a delta-9 tetrahydrocannabinol content of more than seventy (70) percent; or

(d) Any medicinal cannabis product that contains vitamin E acetate.

(2) A processor may possess unfinished medicinal cannabis products not ready for retail sale that exceed the delta-9 tetrahydrocannabinol limits in this section. However, all finished medicinal cannabis products intended for sale to cardholders shall comply with the delta-9 tetrahydrocannabinol limits in this section.

(3) A processor shall use the electronic monitoring system and seed to sale tracking system prescribed by the cabinet containing the requirements in KRS Chapter 218B, specifically KRS 218B.140. A processor shall use the electronic monitoring system and seed to sale tracking system in accordance with written instructions provided by the cabinet.

(4) A processor shall record in the Commonwealth's designated electronic monitoring system and seed to sale tracking system all medicinal cannabis received, sold, disposed, or otherwise transferred by the processor and ensure the inventory is accurate in real-time.

(5) A processor shall establish inventory controls and procedures to conduct inventory reviews and comprehensive inventories at its facility and shall:

Section 5. Employees Records and Identification.

(1) A processor shall keep an individual employment record for all employees, including:

(a) Full legal name;

(b) Detailed job description;

(d) Record of all training received or acquired by the employee;

(e) Dates of employment;

(f) Records of days and hours worked; and

(g) Any disciplinary actions taken by the processor.

(2) Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee's last date of employment with the processor.

(3) A processor shall create an identification badge for each employee, agent, or volunteer. The badge shall be conspicuously worn by employees, agents, or volunteers at all times that they are on the licensed premises or during transport of medicinal cannabis or medicinal cannabis products. The badge shall contain:

(a) The individual's name, photo, employee identification number, and the license number of the processor;

(b) A phone number and email address for the processor; and

Section 6. Visitors to Processor Facilities.

(1) A processor site and facility shall not be open to the general public.

(2) When admitting a visitor to its site and facility, a processor shall:

(a) Require the visitor to sign a visitor log upon entering and leaving the facility;

(b) Check the visitor's government-issued identification to verify the visitor's age and that the name on the identification provided matches the name in the visitor log;

(d) Escort the visitor while the visitor remains on the site or in the facility; and

(e) Ensure that the visitor does not touch any medicinal cannabis or medicinal cannabis product located in a limited access area.

(3) A person under the age of eighteen (18) shall not be permitted to enter a processor's site or facility. A person who is at least eighteen (18) years of age may enter and remain on the processor's premises if that person is present to perform contract work, including electrical, plumbing, or security maintenance, which does not involve handling medicinal cannabis, or is a government employee and is at the cannabis business in the course of his or her official duties.

(4) A processor shall post a sign in a conspicuous location at each entrance of its site and facility that states "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER." The letters on the signs required by this subsection shall be at minimum one-half (1/2) inch in height.

(5) The processor shall maintain the visitor log required under this section for five (5) years and make the visitor log available to the cabinet, law enforcement, and other federal or state government officials upon request to perform the government officials' functions and duties. The visitor log shall include the date, the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit.

(6) This section shall not limit the right of the cabinet or its authorized agents, or other federal, state, or local government officials from entering any area of a processor's site and facility if necessary to perform the governmental officials' functions and duties.

(7) A principal officer, board member, agent, financial backer, employee, or volunteer of a processor shall not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.

Section 7. Security and Surveillance.

(1) A processor shall have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry and to prevent and detect an adverse loss. The security and surveillance systems shall include:

(a) A professionally monitored security alarm system that includes:

Coverage of all facility entrances and exits; rooms with exterior windows, exterior walls, roof hatches, or skylights; storage rooms, including those that contain medicinal cannabis and safes; and the perimeter of the facility;
An audible security alarm system signal, known as a panic alarm, generated by the manual activation of a device intended to signal a life-threatening or emergency situation requiring law enforcement response;
A silent alarm signal, known as a holdup alarm, generated by the manual activation of a device intended to signal a robbery in progress;
A failure notification system that provides an audible, text, or visual notification of any failure in the systems. The failure notification system shall provide by telephone, e-mail, or text message an alert to a designated security person within the facility within five (5) minutes after the failure;
Smoke and fire alarms;
Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to ensure all access doors shall not be solely controlled by an electronic access panel to prevent locks from becoming released during a power outage; and
Motion detectors for exterior lighting; and

Fixed camera placement that allows for a clear image of all individuals and activities in and around:

a. All limited access areas;

b. A room or area containing a security alarm and surveillance system storage device or equipment;

c. Entrances to and exits from the facility. Entrances and exits shall be recorded from both indoor and outdoor vantage points;

d. Rooms with exterior windows, exterior walls, roof hatches, or skylights and storage rooms, including those that may contain medicinal cannabis and safes and excluding restrooms; and

e. Twenty (20) feet from the exterior of the perimeter of the facility;

Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to operate under the normal lighting conditions of each area under surveillance;
The ability to immediately produce a clear, color, still photograph in a digital format that is easily accessible;
The ability to display the date and time clearly and accurately. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture;
The ability to record all images captured by each surveillance camera in a format that shall be easily accessed for a minimum of sixty (60) days, unless otherwise required for investigative or litigation purposes. The recordings shall be kept:

a. At the processor's facility:

(i) In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and

(ii) In a limited access area or other room to which access is limited to authorized individuals; or

b. At a secure location other than the location of the processor's facility if approved by the cabinet; and

The ability to easily export video recordings and still photographs requested by the cabinet, law enforcement, and other federal or state government officials and provide same in a standard file format that is easily accessible.

(2) Regarding inspection, servicing, or alteration of, and any upgrade to, the site and facility's security alarm and surveillance systems:

(a) The systems shall be inspected and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor;

(b) A processor shall conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security alarm and surveillance systems are made for the proper operation of the systems. No more than thirty (30) calendar days shall lapse between the inspections required under this paragraph;

(c) A processor shall retain at the facility, for at least five (5) years, records of all inspections, servicing, alterations, and upgrades performed on the security alarm and surveillance systems and shall make the records available to the cabinet and its authorized agents within two (2) business days following a request; and

(d) If there is a mechanical malfunction of the security alarm or surveillance system that a processor anticipates shall exceed an eight (8) hour period, the processor shall notify the cabinet immediately by electronic mail to kymedcanreporting@ky.gov and, with cabinet approval, provide alternative security measures that may include closure of the facility.

(3) Regarding records retention, a processor shall:

(a) Have a secure electronic back-up system for all electronic records;

(c) If it has been notified in writing by the cabinet or its authorized agents, law enforcement, or other federal, state, or local government officials of a pending criminal or administrative investigation for which a recording may contain relevant information, retain an unaltered copy of the recording for two (2) years or until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the processor that it is not necessary to retain the recording, whichever is later.

(4) During all non-working hours, all entrances to and exits from the processor's facility shall be securely locked.

(5) A processor shall install lighting to ensure proper surveillance inside and outside of the facility.

(6) A processor shall limit access to a room containing the equipment operating the security alarm and surveillance monitoring systems to:

(a) Persons who are essential to maintaining security and surveillance operations;

(b) Federal, state, and local law enforcement;

(d) The cabinet or its authorized agents; and

(e) Other persons with the prior written approval of the cabinet.

(7) A processor shall make available to the cabinet or its authorized agents, upon request, a current list of authorized employees and service employees or contractors who have access to areas containing the equipment operating the security alarm and surveillance monitoring systems and place a copy of this list on or next to the doors that access those areas.

(8) A processor shall keep rooms housing the equipment operating the security alarm and surveillance monitoring systems locked at all times and shall not use these rooms for any other purpose or function.

Section 8. Forms of Medicinal Cannabis.

(1) A processor may process medicinal cannabis for sale to a cannabis business in forms including:

(a) Edible;

(b) Oil;

(d) A form medically appropriate for administration by vaporization or nebulization;

(e) Tincture;

(f) Dermal patch;

(g) Suppositories;

(h) Beverages;

(i) Raw plant material; or

(j) Capsules.

(2) In addition to other packaging and labeling requirements established in 915 KAR 1:100, all raw plant material packaged and sold by a processor in this Commonwealth shall be marked or labeled as "NOT INTENDED FOR CONSUMPTION BY SMOKING." Processors delivering raw plant material to dispensaries for sale shall comply with the requirements established in 915 KAR 1:030, Section 14.

(3) Unless specifically authorized in writing by the cabinet, all hard medicinal cannabis products intended for oral consumption as an edible shall be stamped with the standardized symbol indicating a product contains medicinal cannabis provided in Appendix A to 915 KAR 1:100. If the medicinal cannabis product intended for oral consumption as an edible contains multiple servings, the processor shall ensure a cardholder can easily separate out a single serving from the whole.

(4) Except for transfer of samples to a safety compliance facility for testing, medicinal cannabis shall not be sold or transferred to another cannabis business until all required testing is complete and the representative sample passed inspection. Processors shall not sell medicinal cannabis directly to cardholders.

Section 9. Requirements for Processing Medicinal Cannabis.

(1) A processor shall only use the methods, equipment, solvents, and gases set forth in this section in the processing and manufacture of medicinal cannabis and medicinal cannabis products.

(2) A processor may use hydrocarbon solvent-based extraction methods in a spark-free and properly ventilated environment, isolated from any open flame or ignition source, and may use the following solvents, at a minimum of ninety-nine (99) percent purity, in a professional grade, closed-loop extraction system designed to recover the solvents:

(a) Propane;

(b) N-butane;

(d) Heptane.

(3) A processor may use carbon dioxide-based extraction methods using food grade carbon dioxide at a minimum of ninety-nine (99) percent purity in a professional grade, closed-loop system in which each vessel is rated to a minimum pressure to accommodate the specific extraction protocol, including supercritical, liquid, and subcritical.

(4) A processor may use ethanol at a minimum of ninety-nine (99) percent purity to produce extracts for use in the manufacture of medicinal cannabis products.

(5) A processor may use food grade glycerin and propylene glycol in the manufacture of medicinal cannabis products.

(6) A processor may use non-solvent extraction methods involving the mechanical separation of cannabinoids from plant material to produce medicinal cannabis extracts for use in the manufacture of medicinal cannabis products.

(7) A processor may use non-cannabis ingredients in the manufacture of medicinal cannabis products if:

(a) The non-cannabis ingredients are nontoxic and safe for human consumption; and

(b) The non-cannabis ingredients were not prepared or stored in a private residence.

(8) A processor using hydrocarbon solvent-based or carbon dioxide extraction methods shall designate at least one (1) individual to train and supervise employees in the use of extraction equipment and associated solvents who has earned, at minimum, a Bachelor's Degree in engineering or physical sciences from an accredited university, or who has at least three (3) years of experience in the operation of the equipment being used in the facility or similar equipment.

(9) A processor shall maintain a log of the use of all extraction methods, equipment, solvents, and gases used in the processing and manufacture of medicinal cannabis products for a minimum of five (5) years.

(10) A processor shall only process the parts of the medicinal cannabis plant that are free of dirt, sand, debris, or other foreign matter.

(11) Prior to processing, a processor shall perform visual inspections of the raw plant material to ensure there are no visible insects, mold, mildew, pests, rot, grey or black plant material, or inorganic material, including plastic, glass, and metal shavings.

(12) A processor shall have a separate and secure area for temporary storage of medicinal cannabis that is awaiting disposal by the processor.

(13) A processor shall process medicinal cannabis in a safe and sanitary manner, which includes that:

(a) Medicinal cannabis, raw plant material, and other product used in the processing of medicinal cannabis shall be handled on food-grade stainless steel benches or tables;

(b) Proper sanitation shall be maintained;

(d) Prior to packaging, the medicinal cannabis shall have passed all required testing established within 915 KAR 1:110; and

(e) Any person making human-consumable products or substances that will be used to make human-consumable products, shall be Good Manufacturing Practices-compliant and permitted by the Department of Public Health within the cabinet.

(14) A processor shall establish procedures to monitor, record, and regulate:

(a) Temperature;

(b) Humidity;

(d) Lighting; and

(e) Water supply.

Section 10. Equipment, Operation, and Maintenance.

(1) A processor shall have a written process to maintain the sanitation and operation of equipment that comes into contact with medicinal cannabis to prevent contamination. The processor shall provide a copy of the written process to the cabinet upon request.

(2) As part of the written process required under this section, a processor shall:

(a) Routinely calibrate, check and inspect automatic, mechanical, or electronic equipment as well as any scales, balances, or other measurement devices used in the processor's operations to ensure accuracy; and

(b) Maintain an accurate log recording:

Maintenance of equipment;
Cleaning of equipment; and
Calibration of equipment.

Section 11. Sanitation and Safety in a Processor Facility.

(1) A processor shall maintain its site and facility in a sanitary condition to limit the potential for contamination of the medicinal cannabis processed in the facility, including that:

(a) Equipment and surfaces, including floors, counters, walls, and ceilings, shall be cleaned and sanitized as frequently as necessary to protect against contamination using a sanitizing agent registered by the United States Environmental Protection Agency in accordance with the instructions printed on the label. All equipment and utensils used by a processor shall be capable of being adequately cleaned;

(b) Trash shall be properly and routinely removed to prevent pest infestation;

(d) Equipment, counters, and surfaces for processing shall be food grade quality and shall not react adversely with any solvent being used;

(e) Adequate protection against pests shall be provided through the use of integrated pest management practices and techniques that identify and manage plant pathogens and pest problems; and

(f) Toxic cleaning compounds, sanitizing agents, solvents, and any other allowable chemicals used in the processing of medicinal cannabis shall be labeled and stored in a manner that prevents contamination of medicinal cannabis.

(2) All employees and volunteers shall conform to sanitary practices while on duty, which includes:

(a) Maintaining adequate personal cleanliness;

(b) Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated;

(c) Wearing proper clothing, including gloves, hair nets, headbands, caps, beard covers, or other effective hair restraints where appropriate;

(d) Removing all unsecured jewelry and other objects that might fall into medicinal cannabis, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which medicinal cannabis is manipulated by hand. If hand jewelry cannot be removed, it shall be covered by material which can be maintained in an intact, clean, and sanitary condition that effectively protects the medicinal cannabis from contamination by these objects;

(e) Storing clothing or other personal belongings in areas other than where medicinal cannabis is exposed or where equipment is cleaned;

(f) Eating food, chewing gum, drinking beverages, or using vaping or tobacco products be confined to areas other than where medicinal cannabis may be exposed or where equipment is cleaned; and

(3) A processor shall:

(b) Provide its employees, volunteers, and visitors with adequate, readily accessible restrooms that are maintained in a sanitary condition and in good repair;

(d) Comply with all other applicable federal, state, and local building code requirements and occupational safety and health requirements.

Section 12. Storage Requirements.

(1) A processor shall have separate locked limited access areas for storage of medicinal cannabis that is expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the medicinal cannabis is destroyed or otherwise disposed of as required under Section 13 of this administrative regulation.

(2) A processor shall maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.

Section 13. Management and Disposal of Medicinal Cannabis Waste.

(1) A processor shall dispose of undesired, excess, unauthorized, obsolete, adulterated, misbranded, or deteriorated medicinal cannabis in a manner as to render the medicinal cannabis unusable. A processor shall record medicinal cannabis waste as required in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(2) Medicinal cannabis that is rendered unusable shall be discarded into a dumpster with commercial grade locks or other approved, locked container for removal from the facility by a waste removal company selected by the processor, except that ashes resulting from the controlled incineration of medicinal cannabis may be placed in an unlocked dumpster. Medicinal cannabis shall be rendered unusable by:

(a) Controlled incineration; or

(b) Grinding and incorporating the medicinal cannabis with one (1) or more of the non-consumable, solid wastes listed below so that the resulting mixture is majority non-cannabis waste:

Paper waste;
Cardboard waste;
Food waste;
Yard or garden waste;
Grease or other compostable oil waste; or
Soil or other used growth media.

(4) A minimum of two (2) employees shall oversee the disposal of medicinal cannabis and the processor shall maintain and make available a separate record of every disposal indicating:

(a) The date and time of disposal;

(b) The manner of disposal;

(d) The reasoning for and description of the disposal;

(e) The names, employee identification numbers, and signatures of the employees overseeing the disposal of the medicinal cannabis; and

(f) If the disposal contains medicinal cannabis that was prepared for sale to a dispensary, the harvest or production batch number, strain, volume, weight, and number of units if applicable of the medicinal cannabis being disposed of.

(5) The disposal of other waste from the processor that does not include medicinal cannabis, including hazardous waste and liquid waste, shall be performed in a manner consistent with applicable federal, state, and local requirements.

Section 14. Complaints About or Recall of Medicinal Cannabis and Medicinal Cannabis Products.

(1) A cannabis business shall immediately notify the cabinet by electronic mail to kymedcanreporting@ky.gov, as well as the processor from which it obtained any medicinal cannabis in question, upon becoming aware of any defects or quality issues with the medicinal cannabis or any complaint made to the cannabis business by another cannabis business, a cardholder, or medicinal cannabis practitioner who reports an adverse event from using medicinal cannabis purchased by the cannabis business from the processor. A processor shall investigate the report and shall: immediately investigate a complaint to determine if a voluntary or mandatory recall of medicinal cannabis and medicinal cannabis products is necessary or if any further action is required.

(a) If a processor determines that further action is not required, the processor shall notify the cabinet of its decision by electronic mail to kymedcanreporting@ky.gov and, within twenty-four (24) hours, submit a written report to the cabinet stating its rationale for not taking further action. The cabinet shall review the written report and consult with the processor as needed. If the cabinet disagrees with the processor's decision, the cabinet shall take all necessary steps allowable under KRS Chapter 218B and 915 KAR Chapter 1 to ensure public health and safety, including issuing a cease-and-desist order to pause the sale and distribution of the medicinal cannabis at issue until resolution of the matter.

(b) If a processor determines that further action is required, the processor shall initiate a voluntary or mandatory recall in accordance with the requirements of this section.

(2) Voluntary recalls. If a processor voluntarily initiates a recall, the processor shall recall seeds, seedlings, medicinal cannabis plants, postharvest plant material, or medicinal cannabis from the market at its discretion for reasons that shall not pose a risk to public health and safety and shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov at the time the processor begins the recall.

(3) Mandatory recalls. If a processor discovers that a condition relating to medicinal cannabis processed at its facility poses a risk to public health and safety, the processor shall:

(a) Immediately notify the cabinet by phone and electronic mail to kymedcanreporting@ky.gov; and

(b) Secure, isolate, and prevent the distribution of the medicinal cannabis that may have been affected by the condition and remains in its possession. The processor shall not dispose of affected medicinal cannabis prior to notifying the cabinet and coordinating the disposal with the cabinet.

(4) If a processor fails to cooperate with the cabinet in a recall, or fails to immediately notify the cabinet of a need for a recall under this section, the cabinet may seek a cease-and-desist order and the processor may be subject to any other penalties or sanctions provided for in KRS Chapter 218B and 915 KAR Chapter 1:020.

(5) A processor's recall plan, as required under this administrative regulation, shall include:

(a) Designation of one (1) or more employees to serve as the recall coordinators. A recall coordinator shall be responsible for, among other duties, accepting the recalled medicinal cannabis;

(b) Procedures for identifying and isolating the affected medicinal cannabis to prevent or minimize its distribution to cardholders and other cannabis businesses;

(d) A communications plan to notify those affected by the recall, including:

The manner in which the processor shall notify other cannabis businesses in possession of medicinal cannabis subject to the recall; and
The use of press releases and other appropriate notifications to ensure that cardholders shall be notified of the recall if affected medicinal cannabis was dispensed to cardholders.

(e) Procedures for notifying the cabinet; and

(f) Procedures for entering information relating to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(6) A processor shall follow the procedures outlined in its recall plan unless the processor obtains prior written approval of the cabinet or the cabinet notifies the processor in writing to perform other procedures. A processor shall conduct recall procedures in a manner that maximizes the recall of affected medicinal cannabis and minimizes risks to public health and safety.

(7) A processor shall coordinate the disposal of recalled medicinal cannabis with the cabinet. The cabinet or its authorized agents may oversee the disposal to ensure that the recalled medicinal cannabis is disposed of in a manner that shall not pose a risk to public health and safety.

(8) The processor shall enter information relevant to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system as part of the inventory, which shall include:

(a) The total amount of recalled medicinal cannabis, including types, harvest batches, and production batches, if applicable;

(b) The total amount of recalled medicinal cannabis returned to the processor, including types, forms, harvest batches, and production batches, if applicable;

(d) From whom the recalled medicinal cannabis was received;

(e) The means of transport of the recalled medicinal cannabis;

(f) The reason for the recall;

(g) The number of recalled samples, types, forms, harvest batches, and production batches, if applicable, sent to safety compliance facilities, the names and addresses of the safety compliance facilities, the dates of testing, and the results by sample; and

(h) The manner of disposal of the recalled medicinal cannabis, including:

The names of the individuals overseeing the disposal of the recalled medicinal cannabis;
The name of the disposal company, if applicable;
The method of disposal;
The date of disposal; and
The amount disposed of by types, forms, harvest batches, and production batches, if applicable.

(9) The cabinet may initiate a mandatory recall upon receipt of information that a condition relating to the medicinal cannabis processed by a processor poses a risk to public health and safety.

Section 15. Duty to Report.

(1) At the time a processor submits a license renewal application to the cabinet, the processor shall also report to the cabinet by electronic mail to kymedcanreporting@ky.gov:

(a) Any significant issues with the supply and demand of medicinal cannabis experienced by the processor;

(b) The total amount of raw plant material purchased and processed during the current licensure period and the average price per pound as well as the total amount of raw plant material purchased and sold as raw plant material and the average price per pound; and

(2) A processor shall participate in market surveys distributed by the cabinet throughout a licensure period and provide full and complete responses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements and procedures for medicinal cannabis processor operations in the Commonwealth. This administrative regulation sets out those requirements and procedures.
History: 50 Ky.R. 1815, 2423; 51 Ky.R. 294; eff. 8-28-2024.

915 KAR 1:050 Producer {#sec-915-kar-1-050 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:050}

Section 1. General Requirements.

(1) A person or entity shall not engage in cultivation activities or processing activities in the Commonwealth without first being issued a license by the cabinet. A producer shall not sell or transfer, or allow the sale or transfer, of medicinal cannabis or medicinal cannabis products to any person or entity in the Commonwealth who does not hold a cannabis business license issued by the cabinet.

(2) A producer shall comply with all applicable requirements of KRS Chapter 218B, specifically KRS 218B.095 and 218B.120, and 915 KAR Chapter 1, specifically 915 KAR 1:030 and 915 KAR 1:040.

(3) A producer shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age.

(4) A producer may conduct cultivation and processing activities at separate locations, but shall not operate more than one (1) cultivation and one (1) processing facility per license issued by the cabinet.

(5) If a producer intends to conduct cultivation and processing activities at the same licensed location, the producer shall, prior to its first day of cultivation and processing activities at the same location, provide the cabinet with:

(a) A written plan for keeping strictly separated all cultivation activities from the processing activities; and

(b) A site map or blueprint showing which portions of its facility are designated for cultivation activities and which portions are designated for processing activities.

(6) A producer shall not exceed 50,000 square feet of total canopy size at an enclosed, locked facility.

(7) The qualifications that a producer shall meet to receive a license are continuing qualifications to maintain the license throughout the licensure period.

(8) If a need for additional medicinal cannabis cultivation or processing is demonstrated by cannabis businesses or the cabinet's own analysis, the cabinet may offer currently licensed cultivators or processors with the option to become licensed as a producer at the expiration of their current license. In making this determination, the cabinet may consider factors including:

(a) The population of the Commonwealth;

(b) The number of active cardholders;

(d) Market supply and demand;

(e) Geographic distribution of cannabis businesses;

(f) The desire of cultivators or processors to receive a producer license;

(g) The demonstrated experience of the cultivators and processors;

(h) Workforce development opportunities; and

(i) Any other factors that the cabinet deems relevant to its analysis.

Section 2. Increase of Canopy Limits.

(1) If a need for additional medicinal cannabis cultivation is demonstrated by cannabis businesses or the cabinet's own analysis, the cabinet may through the promulgation of administrative regulations increase the canopy size limits for producers by up to three (3) times the limits established in KRS 218B.120. Any increase in the canopy size limits adopted by the cabinet shall not result in an increase in licensure application or renewal fees established by the cabinet.

(2) In making its determination whether to increase canopy limits for producers, the cabinet may consider factors including:

(a) The population of the Commonwealth;

(b) The number of active cardholders;

(d) Market supply and demand;

(e) The amount of medicinal cannabis being sold by dispensaries;

(f) The amount of allowable canopy space being utilized by producers;

(g) Workforce development opportunities; and

(h) Any other factors that the cabinet deems relevant to its analysis.

Section 3. Duty to Report.

(1) At the time a producer submits a license renewal application to the cabinet, the producer shall report to the cabinet by electronic mail to kymedcanreporting@ky.gov:

(a) The average amount of allowable canopy space being utilized by the producer during the current licensure period. If a producer is not utilizing the full amount of allowable canopy space during the current licensure period, the producer shall provide a written explanation to the cabinet of the reasons for not utilizing all available canopy space;

(b) Any significant issues with the supply and demand of medicinal cannabis experienced by the producer;

(d) The total amount of raw plant material processed during the current licensure period and the average price per pound; and

(e) The number of current employees, their respective job titles, and hourly wage.

(2) A producer shall participate in market surveys distributed by the cabinet throughout a licensure period and provide full and complete responses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements and procedures for medicinal cannabis producer operations in the Commonwealth. This administrative regulation establishes those requirements and procedures.
History: 50 Ky.R. 1821; 51 Ky.R. 300; eff. 8-28-2024.

915 KAR 1:060 Safety compliance facility {#sec-915-kar-1-060 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:060}

Section 1. General Requirements.

(1) A safety compliance facility shall not collect, handle, receive, or conduct tests on medicinal cannabis samples unless it has been issued a license by the cabinet. Prior to conducting any testing of a sample at the request of a cannabis business, a safety compliance facility shall enter into a written contract with the cannabis business for testing services. A safety compliance facility shall provide a copy of its contracts with cannabis businesses to the cabinet within two (2) business days of receipt of the request.

(2) The cabinet shall post a list of licensed safety compliance facilities on the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(3) A safety compliance facility shall employ at least one (1) director to oversee and be responsible for the testing operations of the facility. A director shall have earned, from a college or university accredited by a national or regional accrediting authority, at least one (1) of the following:

(a) A doctorate of science or an equivalent degree in chemistry, biology, or a subdiscipline of chemistry or biology;

(b) A master's level degree in a chemical or biological science and a minimum of two (2) years post-degree experience related to laboratory testing of medicinal or pharmaceutical products; or

(c) A bachelor's degree in a biological science and a minimum of four (4) years post-degree experience related to laboratory testing of medicinal or pharmaceutical products.

(4) A principal officer, board member, employee, volunteer, or agent of a cultivator, processor, producer, or dispensary shall not be employed by or affiliated with a safety compliance facility that has a contract with that respective cannabis business.

(5) A license issued by the cabinet to a safety compliance facility is valid only for the specific site licensed and identified on the license.

(6) A safety compliance facility shall:

(a) Conduct a criminal background check into the criminal history of each person seeking to become a principal officer, board member, agent, volunteer, or employee before that person begins work and shall retain records of these background checks for five (5) years and provide same to the cabinet during subsequent inspections or upon request;

(b) Maintain and adhere to proper standards of accuracy for testing and comply with the testing requirements established in 915 KAR 1:110;

(c) Comply with all required analytes standards for the relevant test methods of cannabinoids, terpenoids, residual solvents and processing chemicals, residual pesticides, heavy metals, microbial impurities, mycotoxins, water activity, yeast, mold, and vitamin E acetate;

(d) Accurately and honestly report all medicinal cannabis test results;

(e) Only allow authorized individuals to perform medicinal cannabis testing and sign reports;

(f) Only accept a sample or test sample from a cannabis business employee or agent, or cardholder, or an authorized representative of the cabinet;

(g) Maintain a certificate of accreditation in good standing from an accreditation body and provide a copy to the cabinet during subsequent inspections or upon request. The certificate of accreditation shall attest to the safety compliance facility's competence to perform testing, including all the required analytes for the relevant test methods required, and shall be obtained by the safety compliance facility prior to collecting, receiving, or testing any medicinal cannabis sample or test sample;

(h) Develop and maintain standard operating procedures for a laboratory approved by the accreditation body that issued the certificate of accreditation to the safety compliance facility and provide copies to the cabinet during subsequent inspections or upon request;

(i) Properly enter medicinal cannabis test results into the Commonwealth's designated electronic monitoring system and seed to sale tracking system as required by the cabinet and in accordance with written instructions provided by the cabinet; and

(j) Comply with all applicable requirements of KRS Chapter 218B, specifically KRS 218B.095 and 218B.125, and 915 KAR Chapter 1.

(7) A safety compliance facility shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age.

(8) The qualifications that a safety compliance facility shall meet to receive a license are continuing qualifications to maintain the license throughout the licensure period.

Section 2. Selecting and Collecting Samples for Testing.

(1) A sampler is an employee or agent of a cultivator, processor, producer, safety compliance facility, or dispensary that is authorized by his or her employer to collect samples or test samples in accordance with the contracted safety compliance facility's standard operating procedures and this administrative regulation. A sampler shall obtain an amount for a sample or test sample on behalf of his or her employer sufficient to be aliquoted into a primary sample and a reserve sample, which shall be equal in amount. The primary sample and reserve sample shall be in the amounts specified in the safety compliance facility's standard operating procedures.

(2) A safety compliance facility shall ensure that samples and test samples are selected and collected in accordance with standard operating procedures established by the safety compliance facility and required by this administrative regulation. The standard operating procedures for sampling shall be written and provided to the cabinet and each cannabis business that the safety compliance facility contracts with for testing prior to collecting, receiving, or testing any medicinal cannabis. These standard operating procedures shall be in place prior to the first day that the safety compliance facility collects, receives, or tests a sample.

(3) Samples shall consist of enough samples from a harvest batch or production batch to ensure that the required attributes in the products are homogenous and consistent with the safety compliance facility's standard operating procedures for selecting and collecting samples. Test samples shall consist of enough samples of the item identified for testing to ensure any required testing can be accomplished in accordance with the safety compliance facility's standard operating procedures.

(4) The sampling policies and procedures shall include:

(a) A step-by-step guide for obtaining samples and test samples;

(b) Random taking of samples or test samples throughout the harvest batch or production batch;

(c) Using appropriate sampling equipment, including protocols relating to the sanitizing of equipment and tools, protective garb, and sampling containers;

(d) Using consistent collection procedures for samples and test samples;

(e) Transporting samples in a manner that does not endanger the integrity of the samples and that is in accordance with transportation requirements for samples established in 915 KAR 1:080;

(f) Creating a unique sample identification number that will be linked to the harvest batch or production batch number assigned by the cultivator, processor, or producer in the Commonwealth's designated electronic monitoring system and seed to sale tracking system; and

(g) The process for properly documenting a chain of custody for each sample or test sample and retaining those records for a minimum of two (2) years.

(5) An employee or agent of a safety compliance facility shall only enter a facility operated by a cultivator, processor, producer, or dispensary for the purpose of:

(a) Selecting and collecting samples and test samples and shall have access to limited access areas in the facility for these purposes; and

(b) Providing training to cannabis business agents as provided in KRS 218B.125(7).

(6) An employee or agent of a safety compliance facility shall comply with all visitor requirements for entry into the cultivator, processor, producer, or dispensary's facility.

(7) An authorized cannabis business employee collecting any samples for testing shall follow the standard operating procedures established by the contracted safety compliance facility conducting the testing for sampling and documenting the chain of custody.

Section 3. Standards for Testing. A safety compliance facility shall follow:

(1) The methodologies and parameters that are contained in the scope of the certificate of accreditation issued to the safety compliance facility; and

(2) The testing requirements established in 915 KAR 1:110.

Section 4. Quality Assurance Program.

(1) Prior to its first day of collecting or receiving samples or test samples in the Commonwealth, a safety compliance facility shall establish and implement a written quality assurance program to ensure that measurements are accurate, errors are controlled, and equipment, devices, or instruments used for testing are routinely and properly calibrated in accordance with the equipment, device, or instrument manufacturer recommendations regarding calibration and frequency.

(2) The quality assurance program required under this section shall include:

(a) An organizational chart that includes the testing responsibilities of employees;

(b) A description of sampling procedures to be utilized;

(d) Analytical procedures;

(e) Data reduction and validation procedures; and

(f) A plan for implementing corrective action, when necessary.

(3) A safety compliance facility shall provide a copy of its written quality assurance program to the cabinet upon request or during subsequent inspections or investigations.

Section 5. Cabinet Request for Testing. If the cabinet requests that a safety compliance facility conduct tests on any samples or test samples collected by the cabinet, the safety compliance facility shall comply with the request and directions of the cabinet and provide the cabinet with a written report of the results from a sample tested under this section within seven (7) calendar days of receipt of the sample, or sooner if requested by the cabinet.

Section 6. Ownership Prohibition. The following individuals shall not have a management or a direct or indirect financial or other ownership interest in a safety compliance facility:

(1) An owner, principal officer, board member, financial backer, employee, volunteer, or agent of a cultivator, processor, producer, or dispensary; and

(2) A medicinal cannabis practitioner.

Section 7. Plans of Operation.

(1) In addition to any other standard operating procedures required by this administrative regulation, and prior to its first day of collecting or receiving samples or test samples in the Commonwealth, a safety compliance facility shall establish standard operating procedures for :

(a) Employment policies and procedures;

(b) Security, including:

Staff identification measures and use of employee identification badges;
Monitoring of attendance of staff and visitors;
Alarm systems;
Video surveillance;
Monitoring and tracking samples and test results, including use of the Commonwealth's electronic monitoring system and seed to sale tracking system established pursuant to KRS 218B.140;
Personnel security;
Transportation of medicinal cannabis and how to properly secure medicinal cannabis in the event of a traffic collision or transport vehicle malfunction;
Cash management and anti-fraud procedures;
Measures to prevent loitering, which shall include signage; and
Storage of medicinal cannabis and medicinal cannabis products;

(d) The process for receiving, handling, packaging, labeling, storing, transporting, and disposing of medicinal cannabis samples;

(e) Employee qualifications, supervision, and training;

(f) Workplace safety;

(g) Waste disposal and sanitation;

(h) Inventory management, including intake, labeling, and storage of samples and test samples;

(i) Contamination;

(j) Maintenance, cleaning, and sanitation of equipment used to test samples;

(k) Maintenance, cleaning, and sanitation of the safety compliance facility;

(l) Proper handling and storage of any chemical or substance used in testing medicinal cannabis;

(m) Investigation of complaints and potential adverse events received from other cannabis businesses, registered qualified patients, designated caregivers, or medicinal cannabis practitioners regarding the safety compliance facility's operations;

(n) Preventing unlawful diversion of medicinal cannabis; and

(o) Any other standard operating procedures required for all cannabis businesses in KRS Chapter 218B and 915 KAR Chapter 1.

(2) A safety compliance facility shall make its standard operation procedures available to the cabinet upon request and during any inspection or investigation.

Section 8. Facilities.

(1) A safety compliance facility shall only test samples in a facility on the specific site licensed by the cabinet and identified on its license issued by the cabinet. The facility shall:

(a) Have a complete roof enclosure supported by connecting permanent walls, constructed of solid materials extending from the ground to the roof;

(b) Be secure against unauthorized entry;

(d) Have commercial grade door locks on all external doors that are locked at all times;

(e) Restrict access to only authorized personnel to limited access areas identified with signage and daily records of entry and exit;

(g) Store toxic cleaning compounds, sanitizing agents, and substances used in testing samples in a manner that is in accordance with applicable local, state, and federal laws and regulations;

(h) Maintain proper ventilation;

(i) Maintain pest control;

(j) Maintain adequate indoor and exterior lighting to facilitate video surveillance at all times;

(k) Maintain adequate on-site parking for employees, agents, visitors, transporters of medicinal cannabis, or cabinet staff; and

(l) Meet all applicable state and local building codes and specifications.

(2) A safety compliance facility shall clearly mark all limited access areas on its premises with proper signage. All areas of ingress and egress to a limited access area shall be clearly identified by the posting of a sign which shall be not less than twelve (12) inches wide and twelve (12) inches long, composed of letters not less than one-half (1/2) inch in height, which shall state: "Do Not Enter. Limited Access Area. Access Limited to Authorized Personnel and Escorted Visitors."

(3) A safety compliance facility shall have a secure area for the loading and unloading of medicinal cannabis samples into and from a transport vehicle.

Section 9. Employee Records and Identification.

(1) A safety compliance facility shall keep an individual employment record for all employees, including:

(a) Full legal name;

(b) Detailed job description;

(d) Record of all training received or acquired by the employee;

(e) Dates of employment;

(f) Records of days and hours worked; and

(g) Any disciplinary actions taken by the safety compliance facility.

(2) Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee's last date of employment with the safety compliance facility.

(3) A safety compliance facility shall create an identification badge for each employee, agent, or volunteer. The badge shall be conspicuously worn by employees or agents at all times that they are on the licensed premises or during transport of samples or test samples. The badge shall contain:

(a) The individual's name, photo, employee identification number, and the license number of the safety compliance facility;

(b) A phone number and email address for the safety compliance facility; and

Section 10. Visitors to Safety Compliance Facilities.

(1) A safety compliance facility shall not be open to the general public.

(2) When admitting a visitor to its site and facility, a safety compliance facility shall:

(a) Require the visitor to sign a visitor log upon entering and leaving the facility;

(b) Check the visitor's government-issued identification to verify the visitor's age and that the name on the identification provided matches the name in the visitor log;

(d) Escort the visitor while the visitor remains in the facility; and

(e) Ensure that the visitor does not touch any medicinal cannabis located in a limited access area.

(3) A person under the age of eighteen (18) shall not be permitted to enter a safety compliance facility. A person who is at least eighteen (18) years of age may enter and remain on the premises if that person is present to perform contract work, including electrical, plumbing, or security maintenance, which does not involve handling medicinal cannabis, or is a government employee and is at the facility in the course of his or her official duties.

(4) A safety compliance facility shall post a sign in a conspicuous location at each entrance of its facility that states "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER." The letters on the signs required by this subsection shall be at minimum one-half (1/2) inch in height.

(5) A safety compliance facility shall maintain the visitor log required under this section for five (5) years and make the visitor log available to the cabinet, law enforcement, and other federal or state government officials upon request to perform the government officials' functions and duties. The visitor log shall include the date, the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit.

(6) This section shall not limit the right of the cabinet or its authorized agents, or other federal, state, or local government officials from entering any area of a safety compliance facility if necessary to perform the governmental officials' functions and duties.

(7) A principal officer, board member, agent, financial backer, or employee of a safety compliance facility shall not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.

Section 11. Security and Surveillance.

(1) A safety compliance facility shall have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry and to prevent and detect an adverse loss. The security and surveillance systems shall include:

(a) A professionally monitored security alarm system that includes:

Coverage of all facility entrances and exits, storage rooms, including those that contain medicinal cannabis and safes, and the perimeter of the facility;
Smoke and fire alarms;
Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to ensure all access doors are not solely controlled by an electronic access panel to prevent locks from becoming released during a power outage; and
Motion detectors for exterior lighting; and

Fixed camera placement that allows for a clear image of all individuals and activities in and around:

a. All limited access areas;

b. A room or area containing a security alarm and surveillance system storage device or equipment;

c. Entrances to and exits from the facility; and

d. Twenty (20) feet from the exterior of the perimeter of the facility;

The ability to operate under the normal lighting conditions of each area under surveillance;
The ability to immediately produce a clear, color, still photograph in a digital format that is easily accessible;
The ability to display the date and time clearly and accurately. The date and time shall be synchronized and set correctly and shall not significantly obscure the picture;
The ability to record all images captured by each surveillance camera in a format that shall be easily accessed for a minimum of sixty (60) days, unless otherwise required for investigative or litigation purposes. The recordings shall be kept:

a. At the safety compliance facility:

(i) In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and

(ii) In a limited access area or other room to which access is limited to authorized individuals; or

b. At a secure location other than the location of the safety compliance facility if approved by the cabinet; and

The ability to easily export video recordings and still photographs requested by the cabinet, law enforcement, and other federal or state government officials and provide same in a standard file format that is easily accessible.

(2) The following requirements apply to the inspection, servicing, or alteration of, and any upgrade to, the security alarm and surveillance systems:

(a) The systems shall be inspected and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor;

(b) A safety compliance facility shall conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security alarm and surveillance systems are made for the proper operation of the systems. No more than thirty (30) calendar days shall lapse between the inspections required under this paragraph ;

(c) A safety compliance facility shall retain at the facility, for at least five (5) years, records of all inspections, servicing, alterations, and upgrades performed on the security alarm and surveillance systems and shall make the records available to the cabinet and its authorized agents within two (2) business days following a request; and

(d) If there is a mechanical malfunction of the security alarm or surveillance system that a safety compliance facility anticipates will exceed an eight (8) hour period, the safety compliance facility shall notify the cabinet immediately by electronic mail to kymedcanreporting@ky.gov and, with cabinet approval, provide alternative security measures that may include closure of the facility.

(3) Regarding records retention, a safety compliance facility shall:

(a) Have a secure electronic back-up system for all electronic records;

(4) During all non-working hours, all entrances to and exits from the safety compliance facility shall be securely locked.

(5) A safety compliance facility shall install lighting to ensure proper surveillance inside and outside of the facility.

(6) A safety compliance facility shall limit access to a room containing the equipment operating the security alarm and surveillance monitoring systems to:

(a) Persons who are essential to maintaining security and surveillance operations;

(b) Federal, state, and local law enforcement;

(d) The cabinet or its authorized agents; and

(e) Other persons with the prior written approval of the cabinet.

(7) A safety compliance facility shall make available to the cabinet or its authorized agents, upon request, a current list of authorized employees and service employees or contractors who have access to areas containing the equipment operating the security alarm and surveillance monitoring systems and place a copy of this list on or next to the doors that access those areas.

(8) A safety compliance facility shall keep rooms housing the equipment operating the security alarm and surveillance monitoring systems locked at all times and shall not use these rooms for any other purpose or function.

Section 12. Electronic Monitoring System and Seed to Sale Tracking System.

(1) A safety compliance facility shall use the electronic monitoring system and seed to sale tracking system prescribed by the cabinet containing the requirements in KRS Chapter 218B, specifically KRS 218B.140. A safety compliance facility shall use the electronic monitoring system and seed to sale tracking system in accordance with written instructions provided by the cabinet.

(2) A safety compliance facility shall record in the Commonwealth's designated electronic monitoring system and seed to sale tracking system all medicinal cannabis received, disposed, or otherwise transferred by the safety compliance facility and ensure the inventory is accurate in real-time.

(3) A safety compliance facility shall establish inventory controls and procedures to conduct inventory reviews and comprehensive inventories at its facility to include:

(a) Preparing monthly physical inventory reports that include any necessary adjustments and the reason(s) for an adjustment and that demonstrate the physical inventory reconciles with the inventory recorded in the commonwealth's designated electronic monitoring system and seed to sale tracking system, including any medicinal cannabis that has been or is in the process of being destroyed. No more than thirty (30) calendar days shall lapse between the preparation of a report required under this paragraph; and

(b) Creating and maintaining a written or electronic record of each inventory conducted under this section that includes the date of the inventory, a summary of the inventory findings, and the employee identification numbers and titles or positions of the individuals who conducted the inventory.

Section 13. Equipment, Operation, and Maintenance.

(1) A safety compliance facility shall have a written process to maintain the sanitation and operation of equipment that comes into contact with samples to prevent contamination. A safety compliance facility shall provide a copy of the written process to the cabinet upon request.

(2) As part of the written process required under this section, a safety compliance facility shall:

(a) Routinely check and inspect automatic, mechanical, or electronic equipment as well as any measurement devices used in the safety compliance facility's operations to ensure accuracy; and

(b) Maintain an accurate log recording the:

Maintenance of equipment;
Cleaning of equipment; and
Calibration of equipment.

Section 14. Sanitation and Safety in a Safety Compliance Facility.

(1) A safety compliance facility shall maintain its site and facility in a sanitary condition to limit the potential for contamination of samples, including that:

(a) Equipment and surfaces, including floors, counters, walls, and ceilings, shall be cleaned and sanitized as frequently as necessary to protect against contamination using a sanitizing agent registered by the United States Environmental Protection Agency in accordance with the instructions printed on the label. All equipment and utensils used by a safety compliance facility shall be capable of being adequately cleaned;

(b) Trash shall be properly and routinely removed;

(d) Adequate protection against pests shall be provided; and

(e) Toxic cleaning compounds, sanitizing agents, and other chemicals shall be labeled and stored in a manner that prevents contamination of samples, and in a manner that otherwise complies with other applicable laws, rules, and regulations.

(2) All employees shall conform to sanitary practices while on duty, which includes:

(a) Maintaining adequate personal cleanliness;

(b) Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated;

(c) Wearing proper clothing, including gloves, hair nets, headbands, caps, beard covers, or other effective hair restraints where appropriate;

(d) Removing all unsecured jewelry and other objects that might fall into medicinal cannabis, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which medicinal cannabis is manipulated by hand. If hand jewelry cannot be removed, it shall be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects the medicinal cannabis from contamination by these objects;

(e) Storing clothing or other personal belongings in areas other than where medicinal cannabis is exposed or where equipment is cleaned;

(f) Eating food, chewing gum, drinking beverages, or using vaping or tobacco products be confined to areas other than where medicinal cannabis may be exposed or where equipment is cleaned; and

(3) A safety compliance facility shall provide its employees and visitors with adequate and convenient hand-washing facilities furnished with running water at a temperature suitable for sanitizing hands. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable drying devices shall also be provided.

(4) A safety compliance facility shall provide its employees and visitors with adequate, readily accessible restrooms that are maintained in a sanitary condition and in good repair.

(5) A safety compliance facility shall ensure that its facility is provided with a water supply sufficient for its operations, which shall be derived from a source that is a public water system, or a nonpublic system that is capable of providing a safe, potable, and adequate supply of water to meet the operational needs of the facility.

(6) A safety compliance facility shall comply with all other applicable federal, state, and local building code requirements and occupational safety and health requirements.

Section 15. Storage Requirements.

(1) A safety compliance facility shall have separate locked limited access areas for storage of all samples and test samples until they can be tested and destroyed or otherwise disposed of as required under Section 16 of this administrative regulation.

(2) A safety compliance facility shall maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.

Section 16. Management and Disposal of Medicinal Cannabis Waste.

(1) A safety compliance facility shall dispose of samples in a manner as to render the medicinal cannabis unusable. A safety compliance facility shall record medicinal cannabis waste as required in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(2) Medicinal cannabis that is rendered unusable shall be discarded into a dumpster with commercial grade locks or other approved, locked container for removal from the facility by a waste removal company selected by the safety compliance facility, except that ashes resulting from the controlled incineration of medicinal cannabis may be placed in an unlocked dumpster. Medicinal cannabis shall be rendered unusable by:

(a) Controlled incineration; or

(b) Grinding and incorporating the medicinal cannabis with one (1) or more of the non-consumable, solid wastes listed below so that the resulting mixture is majority non-cannabis waste:

Paper waste;
Cardboard waste;
Food waste;
Yard or garden waste;
Grease or other compostable oil waste; or
Soil or other used growth media.

(4) A minimum of two (2) employees shall oversee the disposal of medicinal cannabis and the safety compliance facility shall maintain and make available a separate record of every disposal indicating:

(a) The date and time of disposal;

(b) The manner of disposal;

(d) The reasoning for and description of the disposal;

(e) The names, employee identification numbers, and signatures of the employees overseeing the disposal of the medicinal cannabis; and

(f) The harvest batch or production batch number and weight of the medicinal cannabis being disposed of.

(5) The disposal of other waste from the safety compliance facility that does not include medicinal cannabis, including hazardous waste and liquid waste, shall be performed in a manner consistent with applicable federal, state, and local requirements.

Section 17. Duty to Report.

(1) At the time a safety compliance facility submits a license renewal application to the cabinet, it shall report to the cabinet by electronic mail to kymedcanreporting@ky.gov:

(a) A list of the cannabis businesses that the safety compliance facility has contracted with for sample testing;

(b) A list of non-testing activities allowed under KRS 218B.125 that the safety compliance facility engaged in during the licensure period, a list of its customers for each activity, and the compensation received for each activity. If the safety compliance facility produced and sold educational materials related to the use of medicinal cannabis, the safety compliance facility shall provide copies of those educational materials to the cabinet upon request;

(d) The number of current employees, their respective job titles, and hourly wage;

(e) The number of samples tested during the previous twelve (12) months; and

(f) The number of samples that failed testing during the previous twelve (12) months and a breakdown of the reason(s) the tests failed.

(2) A safety compliance facility shall participate in surveys distributed by the cabinet throughout a licensure period and provide full and complete responses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements and procedures for safety compliance facilities that provide testing services to medicinal cannabis businesses in the Commonwealth. This administrative regulation sets out those requirements and procedures.
History: 50 Ky.R. 1823, 2430; 51 Ky.R. 301; eff. 8-28-2024.

915 KAR 1:070 Dispensary {#sec-915-kar-1-070 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:070}

Section 1. General Requirements.

(1) A person or entity shall not dispense, sell, or deliver medicinal cannabis to cardholders without first being issued a license by the cabinet.

(2) The cabinet shall post a list of licensed dispensaries on the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(3) A dispensary shall:

(b) Not acquire medicinal cannabis for retail sale from any person or business other than a cannabis business licensed by the cabinet;

(c) Not sell or dispense medicinal cannabis products intended for consumption by vaporizing to a cardholder who is younger than twenty-one (21) years of age or to a designated caregiver for a registered qualified patient who is younger than twenty-one (21) years of age;

(d) Not sell medicinal cannabis directly to a minor;

(e) Not co-locate in a shared space or have any financial arrangement with a medicinal cannabis practitioner;

(f) Not acquire, possess, dispense, sell, offer for sale, transfer, or transport:

Raw plant material with a delta-9 tetrahydrocannabinol (THC) content of more than thirty-five (35) percent;
Medicinal cannabis products intended for oral consumption as an edible, oil, or tincture with more than ten (10) milligrams of THC per serving;
Any medicinal cannabis product not otherwise described in this subsection with a THC content of more than seventy (70) percent; or
Any medicinal cannabis product that contains vitamin E acetate;

(g) Prohibit a cardholder from self-administering or a designated caregiver from assisting with administering medicinal cannabis on the premises of the licensed dispensary location;

(h) Only dispense or sell medicinal cannabis that has passed the testing requirements established in 915 KAR 1:110;

(i) Only dispense or sell medicinal cannabis to a cardholder in a sealed and properly labeled package as required by 915 KAR 1:100;

(j) Maintain adequate on-site parking for employees, agents, visitors, transporters of medicinal cannabis, or cabinet staff; and

(k) Comply with all applicable requirements of KRS Chapter 218B, specifically KRS 218B.095 and 218B.110, and 915 KAR Chapter 1.

(4) A dispensary shall not employ, take on as a volunteer, or have as a board member, principal officer, or agent any person who was convicted of a disqualifying felony offense or is younger than twenty-one (21) years of age.

(5) The qualifications that a dispensary shall meet to receive a license are continuing qualifications to maintain the license throughout the licensure period.

(6) A dispensary shall not package medicinal cannabis and medicinal cannabis products for sale to cardholders.

Section 2. Dispensing Medicinal Cannabis.

(1) A dispensary shall only dispense medicinal cannabis to a registered qualified patient, visiting qualified patient, or designated caregiver who:

(a) Presents a valid registry identification card issued by the cabinet; or

(b) Presents a valid out-of-state registry identification card and documentation of having been diagnosed with a qualifying medical condition if the individual is a visiting qualified patient without a valid registry card issued by the cabinet.

(2) Prior to dispensing medicinal cannabis to registered qualified patients, designated caregivers, and visiting qualified patients who have a registry identification card issued by the cabinet, the dispensary shall:

(a) Verify the validity of the registry identification card through use of the Commonwealth's designated electronic monitoring system;

(b) Verify that the individual presenting the registry identification card is at least eighteen (18) years of age and is the person identified on the registry identification card by examining at least one (1) other form of government-issued photo identification; and

(c) Verify the amount of medicinal cannabis that the registered qualified patients, designated caregivers, and visiting qualified patients who have a registry identification card issued by the cabinet is legally permitted to purchase pursuant to KRS 218B.025 by checking the Commonwealth's designated electronic monitoring system. If a medicinal cannabis practitioner sets forth recommendations, requirements, or limitations as to the form or dosage of medicinal cannabis on the written certification issued to the individual, the medicinal cannabis dispensed shall conform to those recommendations, requirements, or limitations.

(3) Prior to dispensing medicinal cannabis to visiting qualified patients who do not have a registry identification card issued by the cabinet, the dispensary shall:

(a) Review the out-of-state registry identification card presented by the individual to determine any issues with its validity, including checking any expiration date;

(c) Examine documentation provided by the individual of having been diagnosed with a qualifying medical condition. This documentation shall consist of contemporaneous records containing an express statement of diagnosis of a qualifying medical condition and may include a written certification from a physician, patient history and physical report, or a physician summary report; and

(d) Inform the individual that he or she is not permitted to purchase more medicinal cannabis than the amount determined by the cabinet to constitute an uninterrupted ten (10) day supply of medicinal cannabis during a given eight (8) day period.

(4) A dispensary shall maintain records that include specific notations of the type and amount of medicinal cannabis being dispensed to a cardholder and whether it was dispensed directly to a registered qualified patient or visiting qualified patient, or to a registered qualified patient's designated caregiver. Each entry shall include the date and time the medicinal cannabis was dispensed. The data required to be recorded by this subsection shall be entered into the Commonwealth's designated electronic monitoring system and seed to sale tracking system in accordance with written instructions provided by the cabinet.

(5) Prior to the completion of the transaction, the employee conducting the transaction at the dispensary shall prepare a receipt of the transaction, provide a hardcopy or electronic copy of the receipt to the cardholder, and retain a hardcopy or electronic copy of the receipt for the dispensary's records for a minimum of two (2) years. The receipt shall include:

(a) The dispensary's name, address, and license number;

(b) The name of the cardholder;

(d) The form and the quantity of medicinal cannabis dispensed;

(e) Any medicinal cannabis accessories or educational materials included in the transaction; and

(f) The amount paid by the cardholder for the medicinal cannabis and other items.

(6) When dispensing medicinal cannabis to visiting qualified patients with an out-of-state registry identification card and required documentation of having been diagnosed with a qualifying medical condition, a dispensary may assess a convenience fee to be collected as part of the transaction. The convenience fee shall not exceed fifteen (15) dollars per transaction.

Section 3. Limitations on Dispensing Medicinal Cannabis. In addition to other dispensing requirements established in KRS Chapter 218B and this administrative regulation, a dispensary shall not dispense to a cardholder:

(1) A quantity of medicinal cannabis that is greater than the amount indicated on the individual's written certification, if any;

(2) A form or dosage of medicinal cannabis that is listed as a restriction or limitation on the individual's written certification;

(3) A quantity of medicinal cannabis that is greater than the cardholder is legally permitted to purchase at the time of the transaction;

(4) Any expired medicinal cannabis or medicinal cannabis products; and

(5) Any medicinal cannabis or medicinal cannabis products that have been identified as part of a recall.

Section 4. Dispensary Facilities.

(1) A dispensary shall only sell medicinal cannabis within a building or secure structure located on the specific site licensed by the cabinet and identified on its license issued by the cabinet. The building or secure structure shall:

(a) Have a complete roof enclosure supported by connecting permanent walls constructed of solid materials extending from the ground to the roof;

(b) Be secure against unauthorized entry;

(d) Have commercial grade door locks on all external doors that are locked at all times;

(e) Restrict access to only authorized personnel to limited access areas identified with signage and daily records of entry and exit;

(g) Properly store toxic cleaning compounds or sanitizing agents in a manner that is in accordance with applicable local, state, and federal laws and regulations;

(h) Maintain pest control;

(i) Maintain adequate indoor and exterior lighting to facilitate video surveillance at all times; and

(j) Meet all applicable state and local building codes and specifications.

(2) A dispensary shall only dispense medicinal cannabis to a cardholder in an indoor, enclosed, secure facility between the hours of 8 a.m. and 8 p.m.

(3) A dispensary shall not be located at the same site and location used for growing, cultivating, or processing medicinal cannabis, in the same office space as a medicinal cannabis practitioner or other physician, or in the same location as a hemp business.

(4) A dispensary shall not permit a person under eighteen (18) years of age to enter or remain on its premises. A dispensary shall not permit an individual who is not a cardholder to enter or remain on its premises except in accordance with KRS 218B.095(6) and Section 10 of this administrative regulation.

(5) A dispensary shall post a sign in a conspicuous location at each entrance of the facility that reads: "THESE PREMISES ARE UNDER CONSTANT VIDEO SURVEILLANCE. NO ONE UNDER THE AGE OF 18 IS PERMITTED TO ENTER." The letters on the signs required by this subsection shall be at minimum one-half (1/2) inch in height.

(6) A dispensary shall clearly mark all limited access areas on its premises with proper signage. All areas of ingress and egress to a limited access area shall be clearly identified by the posting of a sign which shall be not less than twelve (12) inches wide and twelve (12) inches long, composed of letters not less than one-half (1/2) inch in height, which shall state: "Do Not Enter. Limited Access Area. Access Limited to Authorized Personnel and Escorted Visitors."

(7) A dispensary shall have a secure area for the loading and unloading of medicinal cannabis into and from a transport vehicle.

Section 5. Items and Services Provided at a Dispensary.

(1) Unless expressly authorized by this administrative regulation, a dispensary shall not sell, offer for sale, or dispense any product except medicinal cannabis, medicinal cannabis products, and medicinal cannabis accessories in accordance with this administrative regulation. A dispensary shall not sell prerolled medicinal cannabis products, including joints or blunts or any other products that are solely intended for consumption by smoking.

(2) A dispensary may operate a delivery service for registered qualified patients and designated caregivers in accordance with the delivery service requirements established in 915 KAR 001:080, Section 2.

(3) A dispensary may dispense medicinal cannabis to cardholders using a drive-thru window or curbside pickup service if:

(a) The dispensary notifies the cabinet by electronic mail to kymedcanreporting@ky.gov of its intent to dispense medicinal cannabis using a drive-thru window or curbside pickup service;

(b) The dispensary provides the cabinet with detailed written plans and procedures for drive-thru and curbside pickup operations, including operating hours, how payment will be accomplished, how medicinal cannabis products will be provided to cardholders, and safety and security measures to ensure safe operations;

(d) The dispensary complies with the dispensing requirements established in Sections 2 and 3 of this administrative regulation.

(4) A dispensary may display product examples that have been designated by the dispensary for the purpose of product education for cardholders if:

(a) There is a sign or label conspicuously displayed on or near the product example that clearly states "PRODUCT EXAMPLE FOR DISPLAY PURPOSES ONLY. NOT FOR SALE OR CONSUMPTION" in bold, capital letters;

(b) The product example is packaged in a secure jar protected by a plastic, glass, or metal mesh screen to allow cardholders to see the medicinal cannabis or medicinal cannabis product;

(c) The product example is recorded in the Commonwealth's electronic monitoring system and seed to sale tracking system as a product example; and

(d) At the point a product example has noticeably degraded to where it is no longer representative of a new product, the dispensary shall destroy the product example in accordance with Section 14 of this administrative regulation.

(5) Dispensaries may utilize inducements to assist cardholders. Inducements shall not persuade or influence the use of medicinal cannabis outside of medicinal cannabis practitioner recommendations or limitations or the amounts allowed by KRS Chapter 218B. Authorized inducements may include:

(a) The use of coupons, loyalty programs, and discounts; or

(b) The giving away of educational materials and branded merchandise.

(6) Pursuant to KRS 218B.110(1)(e), a dispensary may accept returns of medicinal cannabis and medicinal cannabis products from a cardholder for the purpose of disposal. A dispensary shall not offer anything of monetary value in return for medicinal cannabis or medicinal cannabis products received from a cardholder, except clearly defective products may be exchanged for the same or similar product of equal or lesser value with no monetary refund. All medicinal cannabis and medicinal cannabis product returns and their subsequent destruction shall be documented by the dispensary.

(7) A dispensary may sell branded merchandise, including t-shirts, mugs, water bottles, and hats.

(8) A dispensary shall not sell any medicinal cannabis accessory that is used solely for the purpose of smoking medicinal cannabis, including rolling papers and lighters.

Section 6. Educational Materials and Product Information.

(1) When dispensing medicinal cannabis, a dispensary shall disseminate evidence-based educational materials and product information regarding dosage, directions for use, and impairment to cardholders who purchase medicinal cannabis as follows:

(a) A dispensary may provide the educational material and product information required under this section to cardholders through the use of a quick response (QR) code that links to the information required under this section. The QR code shall be labeled as "Educational Materials" directly above or below the code and shall be large enough to be smart-phone readable. The QR code may appear on the receipt provided to the cardholder or on a separate sheet of paper provided to the cardholder;

(b) Upon request of the cardholder purchasing the medicinal cannabis, a dispensary shall provide hardcopies of any materials required under this section; and

(c) Upon request of the cabinet, a dispensary shall provide the cabinet with copies of the educational material required under this section within five (5) business days of receipt of the request.

(2) The educational materials and product information required by this section shall include:

(a) The method or methods for administering individual servings of medicinal cannabis;

(b) Dosage or serving size information;

(d) How to obtain appropriate services or treatment for medicinal cannabis abuse;

(e) Any known contraindications associated with medicinal cannabis that may cause harm to the patient; and

(f) How to properly store medicinal cannabis and medicinal cannabis products.

Section 7. Secret Shoppers. The cabinet may utilize secret shoppers to assist with reviewing a dispensary's compliance with KRS Chapter 218B and 915 KAR Chapter 1, including attempting to purchase medicinal cannabis or medicinal cannabis products. The cabinet may conduct an inspection or investigation resulting from a secret shopper's experience.

Section 8. Plans of Operation.

(1) Prior to its first day of selling or dispensing medicinal cannabis in the Commonwealth, a dispensary shall establish standard operating procedures for:

(a) Employment policies and procedures;

(b) Security, including:

Staff identification measures, including use of identification badges;
Monitoring of attendance of staff and visitors;
Alarm systems;
Video surveillance;
Monitoring and tracking inventory, including use of the Commonwealth's electronic monitoring system and seed to sale tracking system established pursuant to KRS 218B.140;
Personnel security;
Transportation of medicinal cannabis and how to properly secure medicinal cannabis in the event of a traffic collision or transport vehicle malfunction;
Cash management and anti-fraud procedures;
Measures to prevent loitering, which shall include signage;
Storage of medicinal cannabis and medicinal cannabis products; and
Customer service, including procedures for halting a sale;

(d) The process for receiving, handling, transporting, storing, selling, and disposing of medicinal cannabis;

(e) Employee qualifications, supervision, and training;

(f) Workplace safety;

(g) Waste disposal;

(h) Maintenance, cleaning, and sanitation of facility;

(i) Investigation of complaints and potential adverse events received from other cannabis businesses, cardholders, or medicinal cannabis practitioners;

(j) Preventing unlawful diversion of medicinal cannabis;

(k) A recall plan;

(l) Contamination;

(m) Maintaining confidentiality of cardholder information, including information and documentation provided by visiting qualified patients; and

(n) Any other standard operating procedures required for all cannabis businesses in KRS Chapter 218B and 915 KAR Chapter 1.

(2) A dispensary shall make its standard operation procedures available to the cabinet upon request and during any inspection of the dispensary.

Section 9. Employees Records and Identification.

(1) A dispensary shall keep an individual employment record for all employees, including:

(a) Full legal name;

(b) Detailed job description;

(d) Record of all training received or acquired by the employee;

(e) Dates of employment;

(f) Records of days and hours worked; and

(g) Any disciplinary actions taken by the dispensary.

(2) Employment records shall be maintained, either electronically or in hard copy, for at least five (5) years after the employee's last date of employment with the dispensary.

(3) A dispensary shall create an identification badge for each employee, agent, or volunteer. The badge shall be conspicuously worn by employees, agents, or volunteers at all times that they are on the licensed premises or during transport of medicinal cannabis. The badge shall contain:

(a) The individual's name, photo, employee identification number, and the license number of the dispensary;

(b) The phone number and email address for the dispensary; and

Section 10. Visitor Access to Limited Access Areas.

(1) Except as provided in this section, only authorized employees or agents of a dispensary shall enter a limited access area.

(2) If a visitor requires access to a limited access area in the dispensary's facility, the dispensary shall:

(a) Require the visitor to sign a visitor log upon entering and leaving the limited access area and detail the need for entry;

(b) Check the visitor's government-issued identification to verify the visitor's age and that the name on the identification provided matches the name in the visitor log;

(d) Escort the visitor while the visitor remains at the dispensary location; and

(e) Ensure that the visitor does not touch any medicinal cannabis located in a limited access area.

(3) The visitor log required by this section shall:

(a) Be maintained for five (5) years and available to the cabinet, law enforcement, and other federal or state government officials upon request to perform the government officials' functions and duties; and

(b) Include the full name of each visitor, the visitor identification badge number, the time of arrival, the time of departure, and the purpose of the visit.

(4) This section shall not limit the right of the cabinet or its authorized agents, or other federal, state, or local government officials, from entering any area of a dispensary if necessary to perform the government officials' functions and duties.

(5) A principal officer, board member, agent, financial backer, employee, or volunteer of a dispensary shall not receive any type of consideration or compensation for allowing a visitor to enter a limited access area.

Section 11. Security and Surveillance.

(1) A dispensary shall have security and surveillance systems, utilizing commercial-grade equipment, to prevent unauthorized entry, and to prevent and detect an adverse loss. The security and surveillance systems shall include:

(a) A professionally monitored security alarm system that includes:

Coverage of all facility entrances and exits; rooms with exterior windows, exterior walls, roof hatches, or skylights; storage rooms, including those that contain medicinal cannabis, and safes; and the perimeter of the facility;
An audible security alarm system signal, known as a panic alarm, generated by the manual activation of a device intended to signal a life-threatening or emergency situation requiring law enforcement response;
A silent alarm signal, known as a holdup alarm, generated by the manual activation of a device intended to signal a robbery in progress;
A failure notification system that provides an audible, text, or visual notification of any failure in the systems. The failure notification system shall provide by telephone, e-mail, or text message an alert to a designated security person within the facility within five (5) minutes after the failure;
Smoke and fire alarms;
Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to ensure all access doors are not solely controlled by an electronic access panel to prevent locks from becoming released during a power outage; and
Motion detectors for exterior lighting; and

Fixed camera placement that allows for a clear image of all individuals and activities in and around:

a. All limited access areas;

b. A room or area containing a security alarm and surveillance system storage device or equipment;

c. Entrances to and exits from the facility. Entrances and exits shall be recorded from both indoor and outdoor vantage points;

d. Rooms with exterior windows, exterior walls, roof hatches, or skylights and storage rooms, including those that may contain medicinal cannabis and safes and excluding restrooms; and

e. Twenty (20) feet from the exterior of the perimeter of the facility;

Auxiliary power sufficient to maintain operation for at least twenty-four (24) hours following a power outage;
The ability to operate under the normal lighting conditions of each area under surveillance;
The ability to immediately produce a clear, color, still photograph in a digital format that is easily accessible;
The ability to clearly and accurately display the date and time. The date and time shall be synchronized and set correctly and may not significantly obscure the picture;
The ability to record all images captured by each surveillance camera in a format that may be easily accessed for a minimum of sixty (60) days, unless otherwise required for investigative or litigation purposes. The recordings shall be kept:

a. At the dispensary:

(i) In a locked cabinet, closet, or other secure place to protect it from tampering or theft; and

(ii) In a limited access area or other room to which access is limited to authorized individuals; or

b. At a secure location other than the location of the dispensary if approved by the cabinet; and

The ability to easily export video recordings and still photographs requested by the cabinet, law enforcement, and other federal or state government officials and provide same in a standard file format that is easily accessible.

(2) The following requirements apply to the inspection, servicing, or alteration of, and any upgrade to, the security alarm and surveillance systems:

(a) The systems shall be inspected and all devices tested once every year by a qualified alarm system vendor and a qualified surveillance system vendor;

(b) The dispensary shall conduct maintenance inspections once every month to ensure that any repairs, alterations, or upgrades to the security alarm and surveillance systems are made for the proper operation of the systems. No more than thirty (30) calendar days shall lapse between the inspections required under this paragraph;

(c) The dispensary shall retain at the facility, for at least five (5) years, records of all inspections, servicing, alterations, and upgrades performed on the security alarm and surveillance systems and shall make the records available to the cabinet and its authorized agents within two (2) business days following a request; and

(d) If there is a mechanical malfunction of the security alarm or surveillance system that a dispensary anticipates will exceed an eight (8) hour period, the dispensary shall notify the cabinet immediately by electronic mail to kymedcanreporting@ky.gov and, with cabinet approval, provide alternative security measures that may include closure of the facility.

(3) Regarding records retention, a dispensary shall:

(a) Have a secure electronic back-up system for all electronic records;

(c) If it has been notified in writing by the cabinet or its authorized agents, law enforcement, or other federal, state, or local government officials of a pending criminal or administrative investigation for which a recording may contain relevant information, retain an unaltered copy of the recording for two (2) years or until the investigation or proceeding is closed or the entity conducting the investigation or proceeding notifies the dispensary that it is not necessary to retain the recording, whichever is later.

(4) A dispensary shall install commercial-grade, nonresidential doors and door locks on each external door of the facility. Keys or key codes for all doors shall remain in the possession of designated authorized individuals.

(5) During all non-working hours, all entrances to and exits from the dispensary shall be securely locked.

(6) A dispensary shall limit access to a room containing the equipment operating the security alarm and surveillance monitoring systems to:

(a) Persons who are essential to maintaining security and surveillance operations;

(b) Federal, state, and local law enforcement;

(d) The cabinet or its authorized agents; and

(e) Other persons with the prior written approval of the cabinet.

(7) A dispensary shall make available to the cabinet or its authorized agents, upon request, a current list of authorized employees and service employees or contractors who have access to areas containing the equipment operating the security alarm and surveillance monitoring systems and place a copy of this list on or next to the doors that access those areas.

(8) A dispensary shall keep rooms housing the equipment operating the security alarm and surveillance monitoring systems locked at all times and shall not use these rooms for any other purpose or function.

(9) A dispensary shall routinely inspect its point of sale systems to confirm no malicious software, programs, or applications have been downloaded that affect cardholder or sales information and shall document each inspection in writing. The documentation required under this subsection shall be retained by the dispensary for a minimum of two (2) years from the date of the inspection.

Section 12. Electronic Monitoring System and Seed to Sale Tracking System.

(1) A dispensary shall use the electronic monitoring system and seed to sale tracking system prescribed by the cabinet containing the requirements in KRS Chapter 218B, specifically KRS 218B.140, and in accordance with written instructions provided by the cabinet.

(2) A dispensary shall establish inventory controls and procedures to conduct inventory reviews at its facility and ensure its inventory is accurate in real-time in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(3) A dispensary shall:

(a) Prepare a monthly physical inventory report that includes any necessary adjustments, and the reason(s) for an adjustment, and that demonstrates the physical inventory reconciles with the inventory recorded in the Commonwealth's designated electronic monitoring system and seed to sale tracking system, including any medicinal cannabis that has been or is in the process of being destroyed. No more than thirty (30) calendar days shall lapse between the preparation of a report required under this paragraph ; and

Section 13. Storage Requirements.

(1) A dispensary shall have separate locked limited access areas for storage of:

(a) Medicinal cannabis and medicinal cannabis products that are ready for sale to cardholders; and

(b) Medicinal cannabis that is expired, damaged, deteriorated, mislabeled, contaminated, recalled, or whose containers or packaging have been opened or breached until the medicinal cannabis is returned to another cannabis business, destroyed, or otherwise disposed of as required under Section 14 of this administrative regulation.

(2) A dispensary shall maintain all storage areas in a clean and orderly condition and free from infestation by insects, rodents, birds, and pests.

(3) A dispensary shall store medicinal cannabis and medicinal cannabis products in a manner that prevents degradation of active compounds and spoilage.

(4) A dispensary shall routinely review medicinal cannabis and medicinal cannabis products in its inventory available for sale to identify any products that are past their respective expiration date and remove those products from the saleable inventory.

Section 14. Management and Disposal of Medicinal Cannabis Waste.

(1) A dispensary shall dispose of expired, undesired, excess, unauthorized, obsolete, adulterated, misbranded, or deteriorated medicinal cannabis in a manner as to render the medicinal cannabis unusable. A dispensary shall record medicinal cannabis waste as required in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(2) Medicinal cannabis that is rendered unusable shall be discarded into a dumpster with commercial grade locks or other approved, locked container for removal from the dispensary by a waste removal company selected by the dispensary, except that ashes resulting from the controlled incineration of medicinal cannabis may be placed in an unlocked dumpster. Medicinal cannabis shall be rendered unusable by:

(a) Controlled incineration; or

(b) Grinding and incorporating the medicinal cannabis with one (1) or more of the non-consumable, solid wastes listed below so that the resulting mixture is majority non-cannabis waste:

Paper waste;
Cardboard waste;
Food waste;
Yard or garden waste;
Grease or other compostable oil waste; or
Soil or other used growth media.

(4) A minimum of two (2) employees shall oversee the disposal of medicinal cannabis and the dispensary shall maintain and make available a separate record of every disposal indicating:

(a) The date and time of disposal;

(b) The manner of disposal;

(d) The reasoning for and description of the disposal;

(e) The names, employee identification numbers, and signatures of the employees overseeing the disposal of the medicinal cannabis; and

(f) The harvest or production batch, strain, volume, number of units if applicable, and weight of the medicinal cannabis being disposed.

(5) The disposal of other waste from the dispensary that does not include medicinal cannabis, including hazardous waste and liquid waste, shall be performed in a manner consistent with applicable federal, state, and local requirements.

Section 15. Sanitation and Safety in a Dispensary.

(1) A dispensary shall maintain its facility in a sanitary condition to limit the potential for contamination or adulteration of the medicinal cannabis stored in or dispensed at the facility. The following requirements shall apply:

(a) Trash shall be properly and routinely removed;

(b) Floors, walls, and ceilings shall be kept in good repair;

(d) Toxic cleaning compounds, sanitizing agents, and other chemicals shall be labeled and stored in a manner that prevents contamination of medicinal cannabis, and in a manner that otherwise complies with other applicable laws, rules, and regulations.

(2) All employees shall conform to sanitary practices while on duty, which includes:

(a) Maintaining adequate personal cleanliness;

(b) Washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when hands may have become soiled or contaminated; and

(c) Eating food, chewing gum, drinking beverages, or using vaping or tobacco products be confined to areas other than where medicinal cannabis may be exposed.

(3) A dispensary shall provide its employees and visitors with adequate and convenient hand-washing facilities furnished with running water at a temperature suitable for sanitizing hands. Effective nontoxic sanitizing cleansers and sanitary towel service or suitable drying devices shall also be provided.

(4) A dispensary shall provide employees, agents, volunteers, cardholders, and visitors with adequate, readily accessible restrooms that are maintained in a sanitary condition and in good repair.

(5) A dispensary shall comply with all other applicable federal, state, and local building code requirements and occupational safety and health requirements.

Section 16. Complaints About or Recall of Medicinal Cannabis and Medicinal Cannabis Products.

(1) A dispensary shall immediately notify the cabinet by electronic mail to kymedcanreporting@ky.gov, as well as the cannabis business from which it received any medicinal cannabis in question, upon becoming aware of any defects or quality issues with the medicinal cannabis or any complaint made to the dispensary by another cannabis business, a cardholder, or medicinal cannabis practitioner who reports an adverse event from using medicinal cannabis purchased from the dispensary. A dispensary shall investigate the report and: shall immediately investigate a complaint to determine if a voluntary or mandatory recall of medicinal cannabis and medicinal cannabis products is necessary or if any further action is required.

(a) If a dispensary determines that further action is not required, the dispensary shall notify the cabinet of its decision by electronic mail to kymedcanreporting@ky.gov and, within twenty-four (24) hours, submit a written report to the cabinet stating its rationale for not taking further action. The cabinet shall review the written report and consult with the dispensary as needed. If the cabinet disagrees with the dispensary's decision, the cabinet shall take all necessary steps allowable under KRS Chapter 218B and 915 KAR Chapter 1 to ensure public health and safety, including issuing a cease-and-desist order to pause the sale and distribution of the medicinal cannabis at issue until resolution of the matter.

(b) If a dispensary determines that further action is required, the dispensary shall initiate a voluntary or mandatory recall in accordance with the requirements of this section.

(2) Voluntary recalls. If a dispensary voluntarily initiates a recall, the dispensary shall recall medicinal cannabis from the market at its discretion for reasons that shall not pose a risk to public health and safety and shall notify the cabinet by electronic mail to kymedcanreporting@ky.gov at the time the dispensary begins the recall.

(3) Mandatory recalls. If a dispensary discovers that a condition relating to medicinal cannabis sold at its facility poses a risk to public health and safety, the dispensary shall:

(a) Immediately notify the cabinet by phone and electronic mail to kymedcanreporting@ky.gov; and

(b) Secure, isolate, and prevent the distribution of the medicinal cannabis that may have been affected by the condition and remains in its possession. The dispensary shall not dispose of affected medicinal cannabis prior to notifying the cabinet and coordinating the disposal with the cabinet.

(4) If a dispensary fails to cooperate with the cabinet in a recall, or fails to immediately notify the cabinet of a need for a recall under this section, the cabinet may seek a cease-and-desist order and the dispensary may be subject to any other penalties or sanctions provided for in KRS Chapter 218B and 915 KAR Chapter 1:020.

(5) A dispensary's recall plan, as required under this administrative regulation, shall include:

(a) Designation of one (1) or more employees to serve as the recall coordinators. A recall coordinator shall be responsible for, among other duties, accepting the recalled medicinal cannabis;

(b) Procedures for identifying and isolating the affected medicinal cannabis to prevent or minimize its distribution cardholders and other cannabis businesses;

(d) A communications plan to notify those affected by the recall, including:

The manner in which the dispensary shall notify other cannabis businesses in possession of medicinal cannabis subject to the recall; and
The use of press releases and other appropriate notifications to ensure that cardholders shall be notified of the recall if affected medicinal cannabis was dispensed to cardholders.

(e) Procedures for notifying the cabinet; and

(f) Procedures for entering information relating to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

(6) A dispensary shall follow the procedures outlined in its recall plan unless the dispensary obtains prior written approval of the cabinet or the cabinet notifies the dispensary in writing to perform other procedures. A dispensary shall conduct recall procedures in a manner that maximizes the recall of affected medicinal cannabis and minimizes risks to public health and safety.

(7) Upon receiving notification of a recall from a cannabis business or the cabinet, a dispensary shall cease dispensing the affected medicinal cannabis immediately.

(8) A dispensary shall coordinate the disposal of recalled medicinal cannabis with the cabinet. The cabinet or its authorized agents may oversee the disposal to ensure that the recalled medicinal cannabis is disposed of in a manner that shall not pose a risk to public health and safety.

(9) The dispensary shall enter information relevant to the recall into the Commonwealth's designated electronic monitoring system and seed to sale tracking system as part of the inventory, which may include:

(a) The total amount of recalled medicinal cannabis, including types, harvest batches, and production batches, if applicable;

(b) The total amount of recalled medicinal cannabis returned to the dispensary, including types, forms, harvest batches, and production batches, if applicable;

(d) From whom the recalled medicinal cannabis was received;

(e) The means of transport of the recalled medicinal cannabis;

(f) The reason for the recall;

(h) The manner of disposal of the recalled medicinal cannabis, including:

The names of the individuals overseeing the disposal of the recalled medicinal cannabis;
The name of the disposal company, if applicable;
The method of disposal;
The date of disposal; and
The amount disposed of by types, forms, harvest batches, and production batches, if applicable.

(10) The cabinet may initiate a mandatory recall upon receipt of information that a condition relating to the medicinal cannabis sold by the dispensary poses a risk to public health and safety.

Section 17. Duty to Report.

(1) At the time a dispensary submits a license renewal application to the cabinet, it shall also report to the cabinet by electronic mail to kymedcanreporting@ky.gov:

(a) A list of the cannabis businesses whose medicinal cannabis products are sold at the dispensary;

(b) A list of the forms of medicinal cannabis sold at the dispensary and their average sale price;

(c) The amount of medicinal cannabis purchased by the dispensary during the current licensure period, including a breakdown by product type;

(d) The amount of medicinal cannabis sold by the dispensary during the current licensure period, including a breakdown by product type;

(e) Any significant issues with the supply and demand of medicinal cannabis experienced by the dispensary; and

(f) The number of current employees, their respective job titles, and hourly wage.

(2) A dispensary shall participate in surveys distributed by the cabinet throughout a licensure period and provide full and complete responses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements and procedures for medicinal cannabis dispensaries in the Commonwealth. This administrative regulation establishes those requirements and procedures.
History: 50 Ky.R. 1829, 2437; 51 Ky.R. 306; eff. 8-28-2024.

915 KAR 1:080 Transportation and delivery of medicinal cannabis {#sec-915-kar-1-080 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:080}

Section 1. Transportation of Medicinal Cannabis Between Cannabis Businesses.

(1) A cannabis business shall only transport medicinal cannabis, including seeds, seedlings, and plants, to other cannabis businesses as follows:

(a) A cannabis business shall use a global positioning system (GPS) to ensure safe, efficient delivery of the medicinal cannabis to other cannabis businesses;

(b) Vehicles permitted to transport medicinal cannabis shall:

Be equipped with a locked storage compartment that is part of the transport vehicle or have a locked storage container that has a separate key or combination pad;
Have no markings that would either identify or indicate that the vehicle is being used to transport medicinal cannabis;
Maintain a current state vehicle registration;
Be equipped with an alarm system and a minimum of two (2) video cameras as required by subsection (1)(c) of this section; and
Be insured as required by Kentucky law, specifically KRS 304.39-110;

(c) A transport vehicle shall be staffed with a delivery driver, contain a minimum of two (2) video cameras, one (1) with a clear view of the driver and one (1) with a clear view of the location of the medicinal cannabis, and comply with the following:

The delivery driver shall have a copy of the cannabis business license for the business transporting the medicinal cannabis;
Each delivery driver shall have access to a secure form of communication, such as a cellular telephone, at all times that the vehicle contains medicinal cannabis to contact cannabis businesses and law enforcement through the 911 emergency system;
Each delivery driver shall conspicuously wear an employee identification badge at all times during transport of medicinal cannabis and shall, upon demand, produce it to the cabinet or its authorized agents, law enforcement, or other federal or state government officials if necessary to perform the government officials' functions and duties;
Each delivery driver shall have a valid driver's license; and
While on duty, a delivery driver shall not wear any clothing or symbols that may indicate ownership or possession of medicinal cannabis;

(d) A delivery driver shall proceed in a transport vehicle from a cannabis business facility, where the medicinal cannabis is loaded, directly to the other cannabis business, where the medicinal cannabis is unloaded, without making unnecessary stops. A delivery driver may deliver medicinal cannabis to multiple cannabis businesses during one (1) transport;

(e) A cannabis business shall immediately report to the cabinet, by electronic mail to kymedcanreporting@ky.gov, any vehicle accidents, diversions, losses, or other reportable events that occur during transport of medicinal cannabis;

(f) A transport vehicle shall be subject to inspection by the cabinet or its authorized agents, law enforcement, or other federal or state government officials if necessary to perform the government officials' functions and duties. A transport vehicle may be inspected by the cabinet or its authorized agents while on the premises of a cannabis business during the course of an inspection or investigation;

(g) A cannabis business shall generate a printed or electronic transport manifest that accompanies every transport vehicle transporting medicinal cannabis to other cannabis businesses and it shall contain:

The date the transport manifest was created;
The name, address, telephone number, and license number of the cannabis business transporting the medicinal cannabis and the name of and contact information for a representative of the cannabis business who has direct knowledge of the transport;
If applicable, the name, address, and telephone number of the contracted third party that is transporting medicinal cannabis on behalf of the cannabis business and the name of and contact information for a representative of the third party who has direct knowledge of the transport;
The name, address, telephone number, and license number of the cannabis business receiving the delivery;
The quantity, by weight or unit, of the medicinal cannabis being transported to a cannabis business along with the unique identifier for each harvest batch, production batch, or package;
A statement regarding whether the medicinal cannabis being transported to a cannabis business has been tested and, if so, the unique identifier for the harvest batch or production batch test;
The date and approximate time of departure;
The date and approximate time of arrival;
The transport vehicle's make and model and license plate number;
The name of each person accompanying the transport;
The driver's license number of the delivery driver;
The signature of the delivery driver once delivery has been accomplished; and
The name and signature of a representative of the cannabis business receiving the medicinal cannabis that confirms receipt of the delivery;

(h) When a delivery driver delivers medicinal cannabis to multiple cannabis businesses during one (1) transport, the transport manifest shall correctly reflect the specific medicinal cannabis in transit to each cannabis business location;

(i) A cannabis business shall provide a copy of the transport manifest to the cannabis business receiving the medicinal cannabis described in the transport manifest. To maintain confidentiality, a cannabis business may prepare separate manifests for each recipient;

(j) All medicinal cannabis in transport shall be shielded from public view and placed in a locked storage compartment that is part of the transport vehicle or in a locked storage container that has a separate key or combination pad; and

(k) A cannabis business shall, if requested, provide a copy of any printed or electronic transport manifest to the cabinet or its authorized agents, law enforcement, or other federal or state government officials if necessary to perform the government officials' functions and duties.

(2) Evidence of adverse loss during transport.

(a) If a cannabis business transporting medicinal cannabis discovers a discrepancy in the transport manifest, the cannabis business shall:

Conduct an investigation to determine the cause of the discrepancy and memorialize the findings in writing, which shall be provided to the cabinet within seven (7) calendar days of receiving a request from the cabinet; and;
Amend the cannabis business's standard plan of operation, if necessary, to prevent future discrepancies between the quantity or description of inventory listed in the transport manifest and the quantity or description of inventory delivered.

(b) If a cannabis business transporting medicinal cannabis discovers evidence of, or reasonably suspects, a theft or diversion of medicinal cannabis during transport, the cannabis business shall report its findings or suspicions to the cabinet within eight (8) hours of discovery by electronic mail to kymedcanreporting@ky.gov.

(3) An employee or agent of a safety compliance facility, cultivator, processor, producer, or third-party contractor who transports medicinal cannabis samples from a cultivator, processor, or producer to a safety compliance facility shall:

(a) Protect the physical integrity of the sample;

(b) Keep the composition of the sample intact; and

(c) Protect the sample against factors that interfere with the validity of testing results, including the factors of time and temperature.

(4) A cannabis business may contract with a third-party for transportation and delivery to other cannabis businesses if:

(a) The third-party contractor complies with the transportation requirements of this section;

(b) The cannabis business conducts a criminal background check into the criminal history of each employee or agent of the third-party contractor that will transport medicinal cannabis on its behalf and shall not allow an employee or agent to work for the cannabis business who:

Was convicted of a disqualifying felony offense; or
Is younger than twenty-one (21) years of age;

(c) The cannabis business provides the third-party contractor with a copy of its license and identification badges for the third-party contractor's employees or agents who will transport medicinal cannabis. The badges shall be conspicuously worn at all times during transport of medicinal cannabis and shall contain:

The individual's name, photo, an employee identification number, and the license number of the cannabis business;
A phone number and email address for the cannabis business; and
A phone number and email address for the Kentucky Medical Cannabis Program;

(d) The cannabis business notifies the cabinet by electronic mail to kymedcanreporting@ky.gov of all third parties it has contracted with to transport medicinal cannabis prior to the third party commencing with any transportation of medicinal cannabis and confirms that it has satisfied the requirements of subsection (b) and (c) of this subsection. The cannabis business shall provide the cabinet with any additional information requested by the cabinet regarding the contracted third party's operations.

Section 2. Delivery Services Provided by Dispensaries.

(1) A dispensary may operate a delivery service for registered qualified patients and designated caregivers.

(2) To deliver medicinal cannabis, medicinal cannabis accessories, and educational material to registered qualified patients and designated caregivers, a dispensary shall:

(a) Follow all requirements for dispensing and selling medicinal cannabis to registered qualified patients and designated caregivers in accordance with KRS Chapter 218B and 915 KAR 1:070 prior to delivery;

(b) Accomplish delivery on the date agreed upon by the dispensary and the registered qualified patient or designated caregiver;

(d) Prepare a delivery manifest for each delivery or series of deliveries that includes the names of the delivery driver and any additional employees accompanying the transport, address for each delivery, estimated date and time of delivery, and actual date and time of delivery;

(e) Prepare a receipt for each delivery containing:

The dispensary's name, address, and license number;
The name and address of the registered qualified patient or designated caregiver;
The date the medicinal cannabis was dispensed;
The form and the quantity of medicinal cannabis dispensed;
Any medicinal cannabis accessories or educational materials included in the delivery order; and
The amount paid by the registered qualified patient or designated caregiver for the medicinal cannabis and other items;

(f) At the time of delivery, check the registry identification card of the registered qualified patient or designated caregiver to verify the person accepting delivery is the same person who placed the order. The registered qualified patient or designated caregiver who placed the order shall sign the receipt to confirm receipt of all items delivered and receive a copy of the receipt;

(g) Only deliver medicinal cannabis, medicinal cannabis accessories, and educational material to the Kentucky address identified for the individual in the Commonwealth's designated electronic monitoring system; and

(h) Allow delivery drivers to deliver medicinal cannabis to multiple registered qualified patients and designated caregivers during one (1) transport. When delivery drivers deliver to multiple registered qualified patients and designated caregivers during one (1) transport, the transport manifest shall correctly reflect the specific medicinal cannabis in transit to each individual.

(3) Delivery vehicle and delivery driver requirements.

(a) Transport vehicles used for the delivery of medicinal cannabis by dispensaries to registered qualified patients or designated caregivers shall:

Be equipped with a locked storage compartment that is part of the transport vehicle or have a locked storage container that has a separate key or combination pad;
Have no markings that would either identify or indicate that the vehicle is being used to transport medicinal cannabis;
Maintain a current state vehicle registration;
Be equipped with an alarm system and a minimum of two (2) video cameras as required by subsection (3)(b) of this section; and
Be insured as required by Kentucky law, specifically KRS 304.39-110.

(b) A transport vehicle shall be staffed with a delivery driver and contain a minimum of two (2) video cameras, one (1) with a clear view of the driver and one (1) with a clear view of the location of the medicinal cannabis.

Have a copy of the cannabis business license for the dispensary delivering the medicinal cannabis;
Have an employee identification badge issued by the dispensary that shall be conspicuously worn at all times during delivery of medicinal cannabis;
Have a valid driver's license; and
Not make unnecessary stops.

(d) All medicinal cannabis in transport for delivery to registered qualified patients or designated caregivers shall be shielded from public view and placed in a locked storage compartment that is part of the transport vehicle or in a locked storage container that has a separate key or combination pad.

(e) If a transport vehicle delivering medicinal cannabis is involved in an accident or experiences any type of failure rendering the vehicle immobile or requiring the use of a tow truck, the delivery driver shall notify the cabinet immediately by electronic mail to kymedcanreporting@ky.gov.

History

RELATES TO: KRS Chapter 218B, 304.39-110
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing procedures for the secure transportation, including delivery services provided by dispensaries, of medicinal cannabis by cannabis businesses. This administrative regulation establishes those procedures.
History: 50 Ky.R. 1839, 2447; 51 Ky.R. 314; eff. 8-28-2024.

915 KAR 1:090 Advertising {#sec-915-kar-1-090 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:090}

Section 1. Advertising by Cannabis Businesses.

(1) Cannabis businesses shall not advertise medicinal cannabis sales in print, broadcast, online, by paid in-person solicitation of customers, or by any other advertising device, except that a cannabis businesses may:

(a) Place appropriate signs on its property identifying the business;

(b) Place listings in business directories;

(d) Sponsor health or not-for-profit charity or advocacy events; and

(e) Maintain an informational Web site and social media presence as provided in Section 2 of this administrative regulation.

(2) Cultivators, processors, and producers shall not display any signage, logos, products, or other identifying characteristics on the outside of their respective facilities to alert the public that medicinal cannabis is grown, processed, produced, or stored at the facility.

(3) A cannabis business shall not make any deceptive, false, or misleading assertions or statements on any advertising, advertising device, sign, listing, or informational material.

Section 2. Informational Web site and Social Media Presence.

(1) A cannabis business may maintain an informational Web site and social media presence that provides:

(a) A description of the business and services offered;

(b) A listing of medicinal cannabis or medicinal cannabis products cultivated, processed, produced, or sold by the cannabis business, as well as listing the respective product prices and inducements allowed pursuant to 915 KAR 1:070, Section 5(5);

(d) Certificates of analysis provided by safety compliance facilities for its respective harvest batches and production batches.

(2) The Web site and social media presence may also provide contact information for the cannabis business and a listing of the dispensaries where its medicinal cannabis or medicinal cannabis products are sold, if applicable.

(3) A cannabis business shall provide the cabinet with a list of all informational Web sites and social media accounts maintained by the cannabis business, including links to the respective webpages, and shall not block or prohibit the cabinet from accessing those informational Web sites and any social media postings. A cannabis business shall continually update the list required under this subsection and notify the cabinet of any changes within two (2) business days of the activation or deactivation of any informational Web site or social media account.

(4) An informational Web site or social media presence for a cannabis business shall not:

(a) Contain statements that are deceptive, false, or misleading;

(b) Contain any content that can reasonably be considered to target individuals under the age of eighteen (18), including images of minors, cartoons, toys, or similar images and items typically marketed towards minors, or references to products that are commonly associated with minors or marketed by minors;

(c) Encourage the transportation of medicinal cannabis products across state lines or otherwise encourage illegal activity; and

(d) Display consumption of medicinal cannabis in a manner that does not provide an educational benefit.

(5) An informational Web site or social media presence for a cannabis business shall conspicuously display the following statements:

(a) "Medicinal cannabis is for use by cardholders only"; and

(b) "Keep out of reach of children".

(6) A cannabis business that maintains an informational Web site or social media presence shall utilize appropriate measures to ensure that individuals attempting to access the allowable content are eighteen (18) years of age or older.

Section 3. Removal of Objectionable and Non-conforming Advertising.

(1) A cannabis business shall remove any advertising, advertising device, sign, listing, sponsorship, or online material that the cabinet determines to be in violation of this administrative regulation.

(2) The cabinet shall provide written notice to a cannabis business of any violation of this administrative regulation and specify a reasonable time period for the cannabis business to remove any advertising, advertising device, sign, listing, sponsorship, or online material that the cabinet finds objectionable.

Section 4. Advertising to Other Cannabis Businesses.

(1) Cultivators, processors, producers, or dispensaries may directly promote their business, services, medicinal cannabis, medicinal cannabis products, medicinal cannabis accessories, educational materials, and product information to other cultivators, processors, producers, or dispensaries.

(2) A safety compliance facility shall only promote its medicinal cannabis testing services and other activities allowed by KRS 218B.125 to other cannabis businesses.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing restrictions on advertising, marketing, and signage for cannabis businesses. This administrative regulation establishes those restrictions.
History: 50 Ky.R. 1839, 2447; 51 Ky.R. 314; eff. 8-28-2024.

915 KAR 1:100 Packaging and labeling of medicinal cannabis {#sec-915-kar-1-100 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:100}

Section 1. General Requirements for Packaging and Labeling of Medicinal Cannabis.

(1) Packaging and labeling of any medicinal cannabis or medicinal cannabis product shall not bear:

(a) Any resemblance to the trademarked, characteristic, or product-specialized packaging of any commercially available food or beverage product or be visually reminiscent of major brands of edible noncannabis products;

(b) Any statement, artwork, or design that could reasonably lead an individual to believe that the package contains anything other than medicinal cannabis;

(c) The logo of the cabinet or any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead an individual to believe that the product has been endorsed, manufactured, or approved for use by any state, county, or municipality or any agency thereof; or

(d) Any cartoon, image, graphic, or feature that may make the package attractive to minors.

(2) Medicinal cannabis shall be prepared, packaged, and labeled by a cannabis business at its licensed locations. The original seal of a package may not be broken, except:

(a) For testing at a safety compliance facility;

(b) By a dispensary for the purpose of displaying product examples for the benefit of cardholders; or

Section 2. Packaging of Medicinal Cannabis for Sale to Cardholders.

(1) Pursuant to KRS 218B.140(1)(c)(13), a cannabis business shall comply with 15 U.S.C. secs. 1471 to 1476 when packaging and labeling medicinal cannabis and medicinal cannabis products for sale to cardholders.

(2) When packaging medicinal cannabis and medicinal cannabis products for sale to cardholders, a cannabis business shall ensure each product package:

(a) Is child-resistant and requires at least a two (2) step process of initial opening;

(b) Has a tamper-evident seal;

(d) Contains the following warnings:

The typical length of time for the medicinal cannabis to take effect;
The statements in bold "For medicinal use by cardholders only. KEEP OUT OF REACH OF CHILDREN"; and
For raw plant material packaged for sale to a cardholder, the statement "NOT INTENDED FOR CONSUMPTION BY SMOKING";

(e) Discloses the strain of medicinal cannabis, including whether it is a sativa, indica, or hybrid, form of medicinal cannabis, and standard amount of delta-9 tetrahydrocannabinol (THC), terpenes, and cannabidiol (CBD) in the medicinal cannabis, including:

If the medicinal cannabis product is intended for oral consumption as an edible, oil, or tincture, potency shall be stated as milligrams per serving for total THC and total CBD, as applicable, and milligrams per package for total THC and total CBD, as applicable; and
For concentrates and raw plant material, total THC, total terpenes, and total CBD, as applicable, shall be stated in percentages;

(f) Discloses the amount of medicinal cannabis the product is considered the equivalent to, if applicable;

(g) Discloses any possible allergens;

(h) Is light-resistant and opaque;

(i) Clearly and conspicuously displays the standardized symbol in navy blue provided in Appendix A, which is incorporated by reference, indicating that a product contains medicinal cannabis;

(j) Is resealable, if applicable;

(k) Contains the name and license number of the cannabis business packaging the medicinal cannabis;

(l) Protects the medicinal cannabis from contamination;

(m) Does not impart any toxic or deleterious substance to the medicinal cannabis; and

(n) Provides the telephone number for the National Poison Control Center.

Section 3. Labeling of Medicinal Cannabis for Sale to Cardholders.

(1) Medicinal cannabis and medicinal cannabis products prepared for sale to cardholders shall include a label, with writing no smaller than one-sixteenth of an inch in height, that is firmly affixed to the packaging holding medicinal cannabis or firmly affixed to any outer packaging if used.

(2) The label required by this section shall:

(a) Be made of weather-resistant and tamper-resistant materials;

(b) Be legible;

(d) List any ingredients;

(e) List the specific amount of THC and CBD in the medicinal cannabis included in the package as stated on the certificate of analysis for the medicinal cannabis's harvest batch or production batch. For concentrates, the specific amount of THC and CBD shall be expressed in milligrams and by percentage, as applicable;

(f) List the percentage of total terpenes and the most prevalent terpenes expressed in the medicinal cannabis, as applicable. For concentrates, the specific amount of terpenes shall be expressed in milligrams and by percentage, as applicable;

(g) Provide the name and license number of the cannabis business that cultivated the medicinal cannabis;

(h) Provide the name and license number of the cannabis business that processed the medicinal cannabis, if applicable;

(i) Provide the identifier that is unique to the particular harvest batch or production batch of medicinal cannabis in the package;

(j) List the date the medicinal cannabis was harvested or processed, as applicable;

(k) List the date the medicinal cannabis was packaged;

(l) List the name and license number of the safety compliance facility that tested the medicinal cannabis and the date the medicinal cannabis was tested;

(m) List the expiration date of the medicinal cannabis;

(n) List the method of extraction, if applicable;

(o) If the product contains multiple servings, contain the statement in bold "MULTIPLE SERVINGS";

(p) Include directions for use for concentrates and THC infused medicinal cannabis products; and

(q) If the medicinal cannabis product is intended for oral consumption as an edible, oil, or tincture, provide a nutritional fact panel, the number of individual servings contained within the package, and the amount of THC per serving, which shall not exceed ten (10) milligrams per serving.

(3) Quick response (QR) codes. The label required by this section may contain a QR code that links to information required under this section.

(a) The QR code shall be:

Labeled as "Specific Product Information" directly above or below the QR code; and
Large enough to be smart-phone readable.

(b) The information available through use of a QR code may include:

The name and license number of the cannabis business that cultivated the medicinal cannabis;
The name and license number of the cannabis business that processed the medicinal cannabis, if applicable;
The name and license number of the cannabis business that packaged the medicinal cannabis;
The method of extraction, if applicable; and
The date the medicinal cannabis was packaged.

(c) If a cannabis business makes any of the items listed in subsection 3(b) of this section available through use of a QR code on the product label, the cannabis business shall not be required to include that information directly on the product label.

(4) A dispensary shall affix a sticker to each package of medicinal cannabis sold at its licensed location that contains the dispensary's name, license number, and telephone number.

Section 4. Packaging and Labeling Requirements for Sale or Transfer of Medicinal Cannabis Between Cannabis Businesses.

(1) All medicinal cannabis sold or otherwise transferred between cannabis businesses for the purpose of processing or packaging and labeling for retail sale to cardholders shall:

(a) Regarding packaging:

Fully enclose the medicinal cannabis so that it cannot be seen from outside the packaging;
Protect the medicinal cannabis from contamination; and
Not impart any toxic or deleterious substance to the medicinal cannabis; and

(b) Be accompanied by all tracking tags required by the state's designated seed to sale tracking system for the medicinal cannabis contained in the transfer. The tracking tag required by the state's designated seed to sale tracking system shall be firmly affixed to the outer most packaging of the respective package containing the medicinal cannabis identified by the tag. A transport manifest shall also accompany transfers of medicinal cannabis between cannabis businesses as required by 915 KAR 1:080(1)(g).

(2) Any sale or transfer of medicinal cannabis between cannabis businesses shall be documented in the Commonwealth's designated electronic monitoring system and seed to sale tracking system.

Section 5. Voluntary Packaging and Labeling Compliance Review.

(1) Cannabis businesses shall comply with the packaging and labeling requirements established in this administrative regulation.

(2) Cannabis businesses may submit proposed packaging and labels for medicinal cannabis and medicinal cannabis products intended for sale to cardholders to the cabinet for a voluntary compliance review. Cannabis businesses shall submit proposed packaging and labels in the manner prescribed by the cabinet and made available through the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(3) At the time of submission, a cannabis business requesting a voluntary compliance review for a product shall provide to the cabinet:

(a) Documentation from the packaging company confirming the proposed packaging is child-resistant and has at least a two (2) step process of initial opening;

(b) A clear digital proof or photograph of the product packaging with a file size no greater than twenty-five (25) megabytes;

(c) A clear digital proof or photograph of the product label with a file size no greater than twenty-five (25) megabytes; and

(d) The category of product being submitted, such as raw plant material, concentrate, or infused product.

(4) If the cabinet determines that a voluntary compliance review request is lacking sufficient information upon which to make a determination, the cabinet shall notify the cannabis business in writing of the additional information and documentation needed to complete the review. The cannabis business shall have seven (7) calendar days from the date of the notice to provide the requested information and documentation to the cabinet. If a cannabis business fails to provide the requested information to the cabinet by the deadline, the cabinet shall not provide a compliance determination to the cannabis business for the product submitted.

(5) The nonrefundable fee for the voluntary compliance review established in this section is $200 per product submission and shall be paid by the cannabis business at the time of submission by credit card or automated clearing house (ACH) transfer.

(6) The cabinet shall complete a product packaging and labeling compliance review within twenty-one (21) calendar days of submission to the cabinet, unless additional information is requested by the cabinet as provided in subsection (4) of this section.

(7) Upon completion of its review, the cabinet shall:

(a) For compliant submissions, provide the cannabis business with an electronic notification stating the submitted product packaging and label is in compliance with 915 KAR 1:100. This compliance determination shall only apply to the specific product package and label submitted to the cabinet for review and shall not apply to any variations of that product package or label; or

(b) For non-compliant submissions, provide the cannabis business with an electronic notification stating the submitted product packaging and label is not in compliance with 915 KAR 1:100 and the reasons for that determination. A cannabis business may correct a product package and label previously found to be non-compliant by the cabinet and resubmit that package and label for an additional voluntary compliance review upon payment of the fee established in subsection (5) of this section.

Section 6. Incorporation by Reference.

(1) "Appendix A: Standardized symbol indicating a product contains medicinal cannabis", dated January 4, 2024, is incorporated by reference.

(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, Office of the Secretary, 275 East Main Street, Frankfort, Kentucky 40621, Monday through Friday, 8:30 a.m. to 4:30 p.m.. This material may also be viewed on the Kentucky Medical Cannabis Program's Web site at https://kymedcan.ky.gov.

History

RELATES TO: KRS Chapter 218
STATUTORY AUTHORITY: KRS 218B.140, 15 U.S.C. secs. 1471 to 1476
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing standards for the packaging and labeling of medicinal cannabis transferred, sold, or distributed by cannabis businesses. This administrative regulation establishes those standards.
History: 50 Ky.R. 1842, 2450; 51 Ky.R. 315; eff. 8-28-2024.

915 KAR 1:110 Medicinal cannabis testing {#sec-915-kar-1-110 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:110}

Section 1. General Requirements.

(1) To ensure the suitability and safety for human consumption of medicinal cannabis and medicinal cannabis products, cultivators, processors, and producers shall test medicinal cannabis in accordance with Section 2 of this administrative regulation.

(2) A laboratory shall not test medicinal cannabis under this administrative regulation without being issued a license to operate as a safety compliance facility. A safety compliance facility shall only send medicinal cannabis samples for testing to another licensed safety compliance facility in the Commonwealth.

(3) Batch size.

(a) Cultivators and producers shall separate all harvested medicinal cannabis into harvest batches not to exceed twenty (20) pounds with the exception of any raw plant material to be sold to a processor or producer for the purposes of turning the raw plant material into concentrate which may be separated into harvest batches of no more than fifty (50) pounds.

(b) Processors and producers shall separate all medicinal cannabis product into production batches not to exceed five (5) liters of liquid medicinal cannabis concentrate or nine (9) pounds for nonliquid medicinal cannabis products and, for final medicinal cannabis products, no greater than 1,000 grams of delta-9-tetrahydrocannabinol.

(4) An authorized cannabis business employee or agent collecting any samples for testing shall follow the standard operating procedures established by the contracted safety compliance facility conducting the testing for:

(a) Sampling; and

(b) Documenting the chain of custody.

(5) Testing frequency.

(a) Harvest batch samples shall be obtained and tested post-harvest and prior to sell, transfer, or delivery of the medicinal cannabis from the respective harvest batch.

(b) Production batch samples shall be obtained and tested in their final form prepackaging and prior to sale, transfer, or delivery of the medicinal cannabis from the respective production batch.

(6) Prohibitions.

(a) Cultivators and producers shall not sell, transfer, or deliver any medicinal cannabis from a harvest batch to a dispensary, processor, cultivator, or producer until a sample of the harvest batch has passed all tests required by Section 2 of this administrative regulation.

(b) Processors and producers shall not sell, transfer, or deliver any medicinal cannabis from a production batch to a dispensary, processor, cultivator, or producer until a sample of the production batch has passed all tests required by Section 2 of this administrative regulation.

(c) Dispensaries shall not dispense or sell medicinal cannabis to cardholders until a sample of its harvest or production batch has passed all tests required by Section 2 of this administrative regulation.

(d) Following the collection of a sample from a harvest batch or production batch, medicinal cannabis shall not undergo any additional processing, transforming, or other changes that alter the substance of the medicinal cannabis or otherwise would result in different test results. Any medicinal cannabis that undergoes additional processing, transforming, or other changes that alters the substance of the medicinal cannabis following sample collection shall be tested as required by Section 2 of this administrative regulation prior to any sale, transfer, or delivery to a dispensary, processor, or producer.

(7) The cabinet may select and collect a sample or test sample from a cannabis business at any time. The cabinet may require a cultivator, processor, producer, or dispensary to submit a sample or test sample to a safety compliance facility upon request when the cabinet has reason to believe the medicinal cannabis is unsafe for cardholder consumption or inhalation or has not been tested in accordance with KRS Chapter 218B and Section 2 of this administrative regulation. A cultivator, processor, producer, or dispensary shall provide the samples for testing at their own expense.

(8) Except as authorized in Section 5 of this administrative regulation, cannabis businesses shall properly dispose of and shall not use, sell, or otherwise transfer medicinal cannabis that fails to meet any testing standard or requirement set forth in this administrative regulation. Cannabis businesses shall dispose of this medicinal cannabis waste in accordance with the 915 KAR 1:030, 915 KAR 1:040, 915 KAR 1:060, and 915 KAR 1:070, as applicable.

Section 2. Medicinal Cannabis Tests.

(1) In accordance with Section 3 of this administrative regulation, finished medicinal cannabis products intended for sale by dispensaries to cardholders shall be tested for:

(a) Tetrahydrocannabinol (THC) and cannabinoid concentration;

(b) Terpenoid type and concentration;

(d) Residual pesticides;

(e) Heavy metals;

(f) Microbial impurities;

(g) Mycotoxins;

(h) Water activity (for harvest batches);

(i) Yeast and mold; and

(j) Vitamin E acetate.

(2) The cabinet may conduct additional tests on samples or test samples at its discretion.

(3) For harvest batches consisting of raw plant material not intended for sale to cardholders in its current form, the following tests shall be performed prior to sale or transfer of the harvest batch to another licensed cannabis business:

(a) Residual pesticides; and

(b) THC and cannabinoid concentration.

(4) For production batches consisting of non-finished medicinal cannabis products not intended for sale to cardholders in its current form, the following tests shall be performed prior to sale or transfer of the production batch to another licensed cannabis business:

(a) Residual solvents and processing chemicals;

(b) Heavy metals; and

(5) Harvest batches and production batches tested pursuant to subsections (3) and (4) of this Section that pass those tests shall not be required to be retested for those items in their final form if those batches were not physically or chemically altered following the prior sale or transfer.

Section 3. Maximum Allowable Limits for Medicinal Cannabis Tests.

(1) Cannabinoid and terpenoid concentration. KRS Chapter 218B, specifically KRS 218B.095, KRS 218B.105, KRS 218B.115, and KRS 218B.120, establishes the maximum delta-9 tetrahydrocannabinol content for raw plant material and medicinal cannabis products in the Commonwealth. Cultivators, processors, and producers shall test harvest batch and production batch samples for levels of total THC and cannabinoid concentration and terpenoid type and concentration.

(a) For THC and cannabinoid concentration, the testing shall include:

Total THC;
Total cannabidiol (CBD);
Total cannabinoids;
Tetrahydrocannabinolic acid (THCa);
Delta-9-tetrahydrocannabinol (Delta-9-THC);
Delta-8-tetrahydrocannabinol (Delta-8-THC);
Cannabidiolic acid (CBDA);
Cannabidiol (CBD);
Cannabinol (CBN);
Cannabigerolic acid (CBGa);
Cannabigerol (CBG);
Tetrahydrrocannabivarin (THCV); and
Cannabichromene (CBC);

(b) For terpenoid type and concentration, the testing shall establish the percentage of total terpenes and the most prevalent terpenes expressed in the sample; and.

(c) In accordance with KRS 218B.140(1)(c)(9), cultivators and producers shall track the terpene content of the twelve (12) major terpenoids within each strain of medicinal cannabis that they cultivate in the Commonwealth and provide a written summary of this information to the cabinet upon request.

(2) Residual solvents and processing chemicals. Production batch samples shall be tested for residual solvents and processing chemicals and shall not exceed the maximum allowable concentration for each solvent or chemical used as set forth in Appendix A, which is incorporated by reference.

(3) Residual Pesticides. Harvest batch samples and production batch samples shall be tested for residual pesticides and shall not exceed the maximum allowable concentration for each pesticide used as set forth in Appendix B, which is incorporated by reference.

(4) Heavy Metals. All harvest batch and production batch samples shall be tested for heavy metals, which shall include arsenic, cadmium, lead, and mercury, as follows:

(a) For inhaled medicinal cannabis products, including administration by metered dose nasal spray or pressurized metered dose inhaler, harvest and production batches shall be tested for the following heavy metal analytes and shall comply with the maximum allowable concentration:

Arsenic, maximum allowable concentration: zero and two-tenths (0.2) parts per million (ppm);
Cadmium, maximum allowable concentration: zero and two-tenths (0.2) ppm;
Lead, maximum allowable concentration: zero and five-tenths (0.5) ppm; and
Mercury, maximum allowable concentration: zero and one-tenths (0.1) ppm; and

(b) For medicinal cannabis products not intended to be inhaled, harvest and production batches shall be tested for the following heavy metal analytes and shall comply with the maximum allowable concentration:

Arsenic, maximum allowable concentration: zero and four-tenths (0.4) ppm;
Cadmium, maximum allowable concentration: zero and four-tenths (0.4) ppm;
Lead, maximum allowable concentration: one (1) ppm; and
Mercury, maximum allowable concentration: one and two-tenths (1.2) ppm.

(5) Microbial impurities. Harvest batch samples and production batch samples shall be tested for the presence of microbial impurities. Harvest batch and production batch samples shall be deemed to have passed the microbial impurities testing if:

(a) Total Escherichia coli is not detected above one hundred (100) colony forming units/gram;

(b) Shiga toxin–producing Escherichia coli is not detected in one (1) gram;

(d) Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, and A. terreus are not detected in one (1) gram.

(6) Mycotoxins. Harvest batch and production batch samples shall be tested for the following mycotoxins: aflatoxin B1, B2, G1, and G2 ochratoxin A. A production batch shall be deemed to have passed mycotoxin testing if:

(a) Total of aflatoxin B1, B2, G1, and G2 does not exceed twenty (20) microgram per kilogram (µg/kg) of substance; and

(b) Ochratoxin A does not exceed twenty (20) µg/kg of substance.

(7) Water activity. Harvest batch samples shall be tested to determine the level of water activity. Harvest batch samples shall have a water activity (aw) rate of less than 0.65.

(8) Yeast and mold. Harvest batch and production batch samples shall be tested to determine the level of yeast and mold. Harvest batch and production batch samples shall have a total combined yeast and mold not to exceed 10,000 colony forming units per gram.

(9) Vitamin E acetate. Production batches shall be tested for any detectable level of vitamin E acetate.

Section 4. Failed Testing.

(1) A harvest batch or production batch sample that fails any initial testing may be reanalyzed by the safety compliance facility using the reserve sample for that harvest or production batch.

(2) A harvest batch or production batch shall fail testing if the respective sample exceeds any maximum allowable limit established in Section 3 of this administrative regulation or the maximum allowable delta-9 tetrahydrocannabinol content for raw plant material and medicinal cannabis products established in KRS Chapter 218B:

(a) During an initial test where no reanalysis is requested; or

(b) Upon reanalysis as described in this section.

(3) If a harvest batch or production batch sample fails a test or a reanalysis, the harvest batch or production batch:

(a) May be remediated or sterilized if allowed by Section 5 of this administrative regulation; or

(b) If it cannot be remediated or sterilized in accordance with Section 5 of this administrative regulation, the harvest or production batch shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(4) Medicinal cannabis from a harvest or production batch that failed testing shall not be combined with another harvest or production batch. Mixed products shall be considered adulterated and shall not be sold, transferred, or otherwise delivered to a cannabis business.

Section 5. Remediation.

(1) THC concentration.

(a) If a harvest batch sample exceeds the THC content limit imposed on raw plant material in KRS 218B.095, 218B.105, 218B.115, or 218B.120, the harvest batch shall be deemed medicinal cannabis waste and destroyed by the cultivator or producer in accordance with 915 KAR 1:030.

(b) If a production batch sample exceeds the THC content limits imposed on edibles, oils, tincture, and other medicinal cannabis products by KRS 218B.095, 218B.115, or 218B.120, the production batch may be remediated using procedures that would reduce the concentration of THC to allowable levels provided that the remediation method does not impart any toxic or deleterious substance to the medicinal cannabis in the production batch.

(c) A production batch that is remediated in accordance with this subsection shall be sampled and tested in accordance with Sections 2 and 3 of this administrative regulation.

(d) A processor or producer shall inform the safety compliance facility conducting the retesting prior to samples being taken that the production batch has previously failed testing and is being retested after undergoing remediation. Any remediation methods or remediation solvents used on the production batch being retested shall be disclosed to the safety compliance facility conducting the retesting.

(e) A production batch that exceeds the required THC content limits that is not remediated or that if remediated fails testing shall be deemed medicinal cannabis waste and destroyed by the processor or producer in accordance with 915 KAR 1:040.

(2) Residual solvents and processing chemicals.

(a) If a production batch sample fails residual solvent testing, the production batch may be remediated using procedures that would reduce the concentration of solvents to less than the action level provided that the remediation method does not impart any toxic or deleterious substance to the medicinal cannabis in the production batch.

(b) A production batch that is remediated in accordance with this subsection shall be sampled and tested in accordance with Sections 2 and 3 of this administrative regulation.

(c) A processor or producer shall inform the safety compliance facility conducting the retesting prior to samples being taken that the production batch has previously failed testing and is being retested after undergoing remediation or decontamination. Any remediation methods or remediation solvents used on the production batch being retested shall be disclosed to the safety compliance facility conducting the retesting.

(d) A production batch that fails solvent testing that is not remediated or that if remediated fails testing shall be deemed medicinal cannabis waste and destroyed by the processor or producer in accordance with the 915 KAR 1:040.

(3) Residual Pesticides. A harvest batch or production batch that fails residual pesticide testing shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(4) Heavy metals. A harvest batch or production batch that fails heavy metals testing shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with the 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(5) Microbial impurities.

(a) If a harvest batch or production batch sample fails microbial impurities testing, the harvest batch or production batch may be further processed if the processing method effectively sterilizes the batch and does not impart any toxic or deleterious substance to the medicinal cannabis in the batch.

(b) A harvest batch or production batch that is sterilized in accordance with this subsection shall be sampled and tested in accordance with Sections 2 and 3 of this administrative regulation.

(c) A cultivator, processor, or producer shall inform the safety compliance facility conducting the retesting prior to samples being taken that the harvest or production batch has previously failed testing and is being retested after undergoing sterilization. Any sterilization methods or sterilization solvents used on the harvest or production batch being retested shall be disclosed to the safety compliance facility conducting the retesting.

(d) A harvest batch or production batch that fails microbiological contaminant testing after undergoing a sterilization process in accordance with this subsection shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(6) Mycotoxins. A harvest batch or production batch that fails mycotoxins testing shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(7) Water activity. If a harvest batch sample fails water activity testing, the harvest batch may be further dried and cured by the cultivator or producer. A harvest batch that is further dried and cured shall be sampled and retested in accordance with Sections 2 and 3 of this administrative regulation.

(8) Yeast and mold. A harvest batch or production batch sample that fails yeast and mold testing shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(9) Vitamin E acetate. A harvest batch or production batch that fails vitamin E acetate testing shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(10) Where remediation is allowed, a harvest or production batch shall only be remediated twice. If the harvest or production batch fails testing after a second remediation attempt and the second retesting, the harvest or production batch shall be deemed medicinal cannabis waste and destroyed by the cultivator, processor, or producer in accordance with 915 KAR 1:030 or 915 KAR 1:040 as applicable for their respective business.

(11) Prior to taking any remediation efforts, cultivators, processors, and producers shall:

(a) Create and maintain detailed written procedures for all remediation processes used by the cannabis business and provide those procedures to the cabinet upon request within three (3) business days of receiving the request or during an inspection; and

(b) Document all remediation, sterilization, resampling, retesting, and disposal of medicinal cannabis that fails testing required by Section 2 of this administrative regulation.

Section 6. Certificate of Analysis.

(1) A safety compliance facility shall:

(a) Generate a certificate of analysis (COA) for each harvest batch and production batch sample that the safety compliance facility analyzes; and

(b) Ensure the COA contains the results of all required analyses performed for the harvest batch or production batch sample.

(2) The COA shall contain, at minimum:

(a) The safety compliance facility's name, address, and license number;

(b) The cultivator, processor, or producer's name, address, and license number;

(d) Sample identifying information, including matrix type and unique sample identifiers;

(e) Sample history, including the date collected, the date received by the safety compliance facility, and the date of all sample analyses and corresponding testing results;

(f) The analytical methods, analytical instrumentation used, and corresponding limit of detection (LOD) and limits of quantitation (LOQ);

(g) An attestation from an authorized employee of the safety compliance facility that all testing required by Section 2 of this administrative regulation was performed; and

(h) Analytes detected during the analyses of the harvest batch or production batch sample that are unknown, unidentified, or injurious to human health if consumed, if any.

(3) The safety compliance facility shall report test results for each representative harvest batch or production batch sample on the COA as an overall "pass" or "fail" for the entire batch as follows:

(a) When reporting qualitative results for each analyte, the safety compliance facility shall indicate "pass" or "fail";

(b) When reporting quantitative results for each analyte, the testing facility shall use the appropriate units of measurement for testing the analyte;

(d) When reporting results for any analytes that were detected below the analytical method LOQ, indicate "<LOQ," notwithstanding cannabinoid and terpenoid results;

(e) When reporting results for any analytes that were not detected or detected below the LOD, indicate "ND"; and

(f) Indicate "NT" for any test that the safety compliance facility did not perform.

(4) The safety compliance facility shall retain a reserve sample for each harvest or production batch consisting of any portion of a sample that was not used in the testing process. The reserve sample shall be kept for a minimum of forty-five (45) calendar days after the analyses, after which time it may be destroyed as medicinal cannabis waste by the safety compliance facility in accordance with 915 KAR 1:060.

(5) The safety compliance facility shall securely store the reserve sample in a manner that minimizes the risk of sample degradation, contamination, and tampering.

(6) The safety compliance facility shall provide any reserve samples to the cabinet upon request within three (3) business days of receiving the request.

(7) All certificates of analysis prepared by safety compliance facilities shall be documented in the Commonwealth's designated electronic monitoring system and seed to sale tracking system in accordance with instructions provided by the cabinet.

(8) On any informational Web site that they maintain in accordance with 915 KAR 1:090, Section 2, cultivators, processors, and producers shall publish or provide links to the COAs that they receive from safety compliance facilities for their respective harvest batches and production batches. The information required to be provided under this subsection shall be presented in a way that cardholders can easily access the specific COA for the harvest batch or production batch referenced on the medicinal cannabis product label.

Section 7. Incorporation by Reference.

(1) The following material is incorporated by reference:

(a) "Appendix A: List of residual solvents for medicinal cannabis testing", dated January 4, 2024; and

(b) "Appendix B: List of residual pesticides for medicinal cannabis testing", dated January 4, 2024.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing requirements for random sample testing of medicinal cannabis to ensure quality control. This administrative regulation establishes those requirements and procedures.
History: 50 Ky.R. 1845, 2453; 51 Ky.R. 317; eff. 8-28-2024.

Chapter 2 Patients, Caregivers, and Practitioners

915 KAR 2:001 Definitions for 915 KAR Chapter 2 {#sec-915-kar-2-001 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:001}

Section 1. Definitions.

(1) "Bona fide practitioner-patient relationship" is defined by KRS 218B.010(1).

(2) "Cabinet" means the Cabinet for Health and Family Services.

(3) "Cardholder" is defined by KRS 218B.010(5).

(4) "Certificate of analysis" means a document that confirms that the test performed by a safety compliance facility on a harvest batch or production batch meets the testing requirements set forth by the cabinet.

(5) "Cultivator" is defined by KRS 218B.010(6).

(6) "Designated caregiver" is defined by KRS 218B.010(8).

(7) "Dispensary" is defined by KRS 218B.010(9).

(8) "Disqualifying felony offense" is defined by KRS 218B.010(11).

(9) "Medicinal cannabis" is defined by KRS 218B.010(15).

(10) "Medicinal cannabis practitioner" is defined by KRS 218B.010(17).

(11) "Medicinal cannabis product" is defined by KRS 218B.010(18).

(12) "Minor" is defined by KRS 218B.010(19).

(13) "Out-of-state registry identification card" is defined by KRS 218B.010(20).

(14) "Producer" is defined by KRS 218B.010(23).

(15) "Qualified patient" is defined by KRS 218B.010(25).

(16) "Qualifying medical condition" is defined by KRS 218B.010(26).

(17) "Registered qualified patient" is defined by KRS 218B.010(28).

(18) "Registry identification card" is defined by KRS 218B.010(29).

(19) "Safety compliance facility" is defined by KRS 218B.010(30).

(20) "Serious violation" is defined by KRS 218B.010(33).

(21) "State licensing board" is defined by KRS 218B.010(35).

(22) "Telehealth" is defined by KRS 218B.010(36).

(23) "Visiting qualified patient" is defined by KRS 218B.010(38).

(24) "Written certification" is defined by KRS 218B.010(39).

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations to administer the medicinal cannabis program in the commonwealth. This administrative regulation establishes definitions of terms used by the cabinet in administrative regulations pertaining to qualified patients, visiting qualified patients, designated caregivers, and the medicinal cannabis program.
History: 50 Ky.R. 2122; eff. 8-28-2024.

915 KAR 2:010 Procedures for registry identification cards {#sec-915-kar-2-010 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:010}

Section 1. Patient and Caregiver Registry.

(1) Except for persons who possess valid out-of-state registry identification cards and documentation of having been diagnosed with a qualifying medical condition as defined by KRS 218B.010(26), a person shall not possess, purchase, acquire, or otherwise engage in the use of medicinal cannabis in Kentucky without first applying for and receiving a registry identification card issued by the cabinet.

(2) The eligibility requirements for qualified patients, designated caregivers, and visiting qualified patients to receive a registry identification card from the cabinet are established in KRS 218B.055, including not being convicted of a disqualifying felony offense. The qualifications that a patient or caregiver shall meet to receive a registry identification card are continuing qualifications.

(3) The cabinet shall maintain a patient and caregiver registry for the Kentucky Medical Cannabis Program as part of the state's designated electronic monitoring system. To receive a registry identification card, qualified patients, visiting qualified patients, and designated caregivers shall complete an application in accordance with this administrative regulation.

(4) The cabinet shall adhere to the confidentiality requirements for cardholders and information provided by qualified patients, visiting qualified patients, and designated caregivers established in KRS 218B.135.

(5) Except as provided in KRS 218B.060(3)(b), the expiration date for registry identification cards shall be one (1) year after the date of issuance. A registry identification card shall not be valid beyond the expiration date.

Section 2. Application for a Registry Identification Card.

(1) An applicant shall only use the applicable registry identification card application form prescribed by the cabinet and made available through the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov.

(2) An applicant shall submit a registry identification card application to the cabinet in the manner prescribed by the application instructions and this administrative regulation.

(3) Pursuant to KRS 218B.055(6), a registry identification card application submitted by or on behalf of qualified patients shall include:

(a) The full name, address, telephone number, email address, date of birth, Social Security number, and driver's license number of the qualified patient, except that if the applicant is homeless an address where the applicant may be reached shall be provided to the cabinet;

(b) A written certification issued to the qualified patient by a medicinal cannabis practitioner;

(d) The full name, address, telephone number, email address, and date of birth of not more than two (2) individuals chosen by the qualified patient to be designated as a caregiver if the qualified patient chooses to designate a caregiver, except that if an individual has been appointed as a guardian, limited guardian, conservator, or limited conservator under KRS Chapter 387, the qualified patient shall choose that individual as a designated caregiver;

(e) The application fee for a qualified patient;

(f) An option for the qualified patient to receive notifications from the cabinet of any clinical studies needing human subjects for research on the use of medicinal cannabis in accordance with KRS 218B.055(9);

(g) An attestation that:

The qualified patient authorizes the cabinet to share cardholder information with licensed dispensaries for the purpose of sales and validating registry identification cards; and
The qualified patient authorizes the cabinet to share cardholder information with law enforcement for the purpose of validating registry identification cards; and

(h) A notarized signature page signed by the qualified patient attesting that:

The qualified patient verifies and affirms that all of the information provided in and with his or her application is true and accurate;
The qualified patient understands that if the cabinet later determines any of the information provided in his or her application to be false, misleading, or inaccurate, the cabinet may suspend or revoke any registry identification card issued to the qualified patient and any caregiver designated by the qualified patient; and
The qualified patient shall not divert medicinal cannabis to anyone who is not permitted to possess medicinal cannabis pursuant to KRS Chapter 218B and understands the potential penalties for doing so, including criminal prosecution and revocation of any registry identification card issued to the qualified patient by the cabinet.

(4) Pursuant to KRS 218B.055(7), a registry identification card application submitted by or on behalf of qualified patients under the age of eighteen (18) shall, in addition to the information required under subsection (3) of this section, submit:

(a) Documentation of diagnosis of a qualifying medical condition by a practitioner other than the medicinal cannabis practitioner who provided the written certification for the use of medicinal cannabis; and

(b) A statement signed by the custodial parent or legal guardian with responsibility for health care decisions for the minor qualified patient stating that the custodial parent or legal guardian agrees to:

Allow the minor qualified patient to use medicinal cannabis;
Serve as the minor qualified patient's designated caregiver; and
Control the acquisition, possession, dosage, and frequency of use of medicinal cannabis by the minor qualified patient.

(5) Except as provided in Section 5(4) of this administrative regulation, a caregiver may submit a registry identification card application following issuance of a registry identification card to the qualified patient who designated the caregiver in his or her registry identification card application. A caregiver shall submit a registry identification card application for each registered qualified patient that designated the caregiver in his or her application. Except as provided in KRS 218B.055(3)(b), a caregiver shall not assist more than three (3) registered qualified patients with the use of medicinal cannabis at any given time.

(6) A registry identification card application submitted by a caregiver shall include:

(a) The full name, address, telephone number, email address, date of birth, Social Security number, and driver's license number of the caregiver;

(b) The full name and registry identification card number of the qualified patient who designated the applicant to be his or her caregiver;

(d) An attestation that:

The caregiver authorizes the cabinet to share cardholder information with licensed dispensaries for the purpose of sales and validating registry identification cards; and
The caregiver authorizes the cabinet to share cardholder information with law enforcement for the purpose of validating registry identification cards; and

(e) A notarized signature page signed by the caregiver attesting that:

The caregiver verifies and affirms that all of the information provided in and with his or her application is true and accurate;
The caregiver understands that if the cabinet later determines any of the information provided in his or her application to be false, misleading, or inaccurate, the cabinet may suspend or revoke any registry identification card issued to the caregiver by the cabinet;
The caregiver agrees to be designated as the caregiver for the registered qualified patient identified in his or her application; and
The caregiver shall not divert medicinal cannabis to anyone other than the registered qualified patient to whom he or she is connected through the cabinet's registration process and understands the potential penalties for unlawfully diverting medicinal cannabis, including criminal prosecution and revocation of any registry identification card issued to the caregiver by the cabinet.

(7) Pursuant to KRS 218B.055(8), a registry identification card application submitted by or on behalf of visiting qualified patients shall include:

(a) The full name, address, telephone number, email address, date of birth, Social Security number, and driver's license number of the applicant, except that if the applicant is homeless an address where the applicant may be reached shall be provided to the cabinet;

(b) A copy of his or her valid out-of-state registry identification card;

(c) Documentation that he or she has been diagnosed with a qualifying medical condition as defined by KRS 218B.010(26), which shall consist of one (1) or more medical records containing an express statement of diagnosis from a physician or advanced practice registered nurse;

(d) The application fee for a visiting qualified patient;

(e) An attestation that:

The visiting qualified patient authorizes the cabinet to share cardholder information with licensed dispensaries for the purpose of sales and validating registry identification cards; and
The visiting qualified patient authorizes the cabinet to share cardholder information with law enforcement for the purpose of validating registry identification cards; and

(f) A notarized signature page signed by the visiting qualified patient attesting that:

The visiting qualified patient verifies and affirms that all of the information provided in and with his or her application is true and accurate;
The visiting qualified patient understands that if the cabinet later determines any of the information provided in his or her application to be false, misleading, or inaccurate, the cabinet may suspend or revoke any registry identification card issued to the visiting qualified patient; and
The visiting qualified patient shall not divert medicinal cannabis to anyone who is not permitted to possess medicinal cannabis pursuant to KRS Chapter 218B and understands the potential penalties for doing so, including criminal prosecution and revocation of any registry identification card issued to the visiting qualified patient by the cabinet.

Section 3. Renewing Registry Identification Cards.

(1) To renew a registry identification card, an applicant shall use the registry identification card renewal application form prescribed by the cabinet that contains the items required by Section 2 of this administrative regulation. The renewal application shall be made available through the Web site for the Kentucky Medical Cannabis Program, https://kymedcan.ky.gov. An applicant shall submit a registry identification card renewal application to the cabinet in the manner prescribed by the application instructions and this administrative regulation.

(2) A registered qualified patient applying to renew a registry identification card shall submit to the cabinet a written certification issued by a medicinal cannabis practitioner to the patient within sixty (60) calendar days immediately preceding the date of the renewal application submission.

(3) A registered qualified patient shall submit a registry identification card renewal application to the cabinet no later than thirty (30) calendar days prior to the expiration date on the card.

(4) Except as provided in Section 5(4) of this administrative regulation, a designated caregiver may submit a registry identification card renewal application following issuance of a registry identification card to the registered qualified patient who designated the caregiver in his or her renewal application. A designated caregiver shall submit a registry identification card renewal application for each registered qualified patient that designated the caregiver in his or her renewal application.

Section 4. Fees.

(1) To apply for or renew a registry identification card, the application fee shall be:

(a) Twenty-five (25) dollars for qualified patients;

(b) Twenty-five (25) dollars for visiting qualified patients; and

(2) The fees established by this section shall be paid by credit card or automated clearing house (ACH) transfer at the time of application submission to the cabinet. If the applicant is submitting a paper application to the cabinet instead of an electronic application, the fees established by this section shall be paid by inclusion of a check with the application submission or another form of payment as determined by the cabinet and stated in the paper application instructions. All fees to apply for a registry identification card are nonrefundable.

Section 5. Cabinet Action on Applications; Application Denial.

(1) The cabinet shall acknowledge receipt of an initial or renewal application for a registry identification card within fifteen (15) calendar days of receipt. The cabinet shall review each application to determine whether the application is complete.

(2) The cabinet shall provide notification to applicants as to whether an initial or renewal application for a registry identification card has been approved or denied within thirty (30) calendar days of receiving an application and determining it is complete. Any application denials shall be done in accordance with KRS 218B.065(2), (3), (4), (5), (7), and (8), including:

(a) Providing written notice of the denial and the reason(s) to the applicant; and

(b) Providing written notice that the applicant may, within thirty (30) calendar days after the date of the mailing of the cabinet's notice, file a written request for an administrative hearing on the application. Any hearing resulting from the applicant's written request shall be conducted in accordance with KRS Chapter 13B.

(3) Except as provided in subsection (4) of this section, the cabinet shall issue registry identification cards to qualified patients, designated caregivers, or visiting qualified patients within five (5) calendar days of approving their initial or renewal applications. An individual designated as a caregiver shall be issued a registry identification card for each registered qualified patient to whom he or she is connected through the cabinet's registration process.

(4) Pursuant to KRS 218B.065(2)(b), the cabinet shall not issue a valid registry identification card to a qualified patient who is younger than eighteen (18) years of age unless the designated caregiver application for the custodial parent or legal guardian with responsibility for health care decisions for the qualified patient is approved.

(5) Registry identification cards issued by the cabinet shall include the items required by KRS 218B.060(2).

Section 6. Cardholder Responsibilities.

(1) A cardholder shall adhere to and comply with the notification requirements to the cabinet contained in KRS 218B.070(1)(a) through (e) and comply with the requirements for returning or disposing of medicinal cannabis contained in KRS 218B.070(2) and (5). A cardholder shall provide any required notifications to the cabinet by electronic mail to kymedcancards@ky.gov or through the patient and caregiver registry portal.

(2) During the application process, an applicant for a registry identification card shall, upon discovery of any change in facts or circumstances reflected in the application submitted to the cabinet, notify the cabinet in writing of any change or newly discovered fact or circumstance that would have been included in the application if known at the time the application was submitted. The notification required under this section shall be sent byelectronic mail to kymedcancards@ky.gov within twenty-four (24) hours of discovery. Failure to timely notify the cabinet of a change or newly discovered facts or circumstances may result in denial of the application.

(3) A cardholder shall obtain medicinal cannabis and medicinal cannabis products in the Commonwealth from a dispensary licensed by the cabinet.

(4) The cabinet shall conduct cardholder surveys to request information regarding their ability to obtain timely affordable access to medicinal cannabis in their area and other items relevant to the Kentucky Medical Cannabis Program.

Section 7. Revocation or Suspension of a Registry Identification Card.

(1) Pursuant to KRS 218B.075(1), any cardholder who sells, distributes, or dispenses medicinal cannabis to a person who is not permitted to possess or use medicinal cannabis under KRS Chapter 218B shall have his or her registry identification card revoked and shall be subject to other penalties including criminal prosecution.

(2) The cabinet may revoke or suspend a cardholder's registry identification card if the cardholder knowingly commits multiple violations or a serious violation of KRS Chapter 218B or 915 KAR Chapter 2.

(3) The cabinet shall provide written notice by certified mail to the cardholder of any suspension or revocation of his or her registry identification card. The cardholder may, within thirty (30) days after the date of the mailing of the cabinet's notice, file a written request with the cabinet for an administrative hearing regarding the revocation or suspension. The hearing shall be conducted in compliance with the requirements of KRS Chapter 13B.

Section 8. Material Incorporated by Reference.

(1) "Registry Identification Card Application for Qualified Patients, Visiting Qualified Patients, and Designated Caregivers", dated June 26, 2024, is incorporated by reference.

(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, Office of the Secretary, 275 East Main Street, 2nd Floor, Frankfort, Kentucky 40621, Monday through Friday, 8:30 a.m. to 4:30 p.m.

History

RELATES TO: KRS Chapter 13B, Chapter 218B, Chapter 387
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing procedures for the issuance, renewal, suspension, and revocation of registry identification cards, including the creation of an application form. This administrative regulation establishes those procedures.
History: 50 Ky.R. 2124; 51 Ky.R. 70, 320; eff. 8-28-2024.

915 KAR 2:020 Supply limits and equivalency formula {#sec-915-kar-2-020 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:020}

Section 1. Medicinal Cannabis Supply Limits.

(1) For the purpose of establishing supply limits for the Kentucky Medical Cannabis Program:

(a) A daily supply of medicinal cannabis for cardholders consists of 3.75 grams of raw plant material, 1 gram of concentrate, or 130 milligrams of delta-9 tetrahydrocannabinol (THC) infused into a medicinal cannabis product, such as an edible, pill, capsule, oil, liquid, or tincture;

(b) An uninterrupted ten (10) day supply of medicinal cannabis for cardholders consists of 37.5 grams of raw plant material, 9.5 grams of concentrate, or 1,300 milligrams of THC infused into a medicinal cannabis product; and

(c) An uninterrupted thirty (30) day supply of medicinal cannabis for cardholders consists of 112 grams of raw plant material, 28 grams of concentrate, or 3,900 milligrams of THC infused into a medicinal cannabis product.

(2) The following non-consumable medicinal cannabis products shall not count toward a patient's supply limits:

(a) Ointments;

(b) Soaps;

(d) Other topical agents.

(3) In making recommendations for dosage of medicinal cannabis, a medicinal cannabis practitioner may recommend, and a registered qualified patient or his or her designated caregiver may legally purchase and possess, an amount of medicinal cannabis in excess of the thirty (30) day supply of medicinal cannabis established in this section if the medicinal cannabis practitioner reasonably believes that the standard thirty (30) day supply would be insufficient in providing the patient with uninterrupted therapeutic or palliative relief. If a medicinal cannabis practitioner makes the determination to increase the qualified patient's dosage above the thirty (30) day supply limit, the medicinal cannabis practitioner shall:

(a) Document the dosage recommendation and the rationale in the qualified patient's medical record; and

(b) Document the dosage recommendation and the rationale in the qualified patient's written certification in the state's designated medicinal cannabis practitioner registry.

(4) Beginning January 1, 2026, the cabinet shall annually review the supply limits established in this section to determine if any adjustments should be made. In making this determination, the cabinet shall consider standards and procedures that have been found to be best practices relative to the use of medicinal cannabis, any scientific research studies regarding dosage and the health effects of medicinal cannabis, and any input from the Board of Physicians and Advisors, the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, and the Kentucky Center for Cannabis.

Section 2. Standards for Determining Equivalency.

(1) The following potency equivalency formula shall be used for determining the amount of raw plant material that medicinal cannabis products are considered the equivalent to:

(a) Step 1. Weight of raw plant material (in grams) x average THC potency percentage of raw plant material = amount of concentrate (in grams).

(b) Step 2. Convert amount of concentrate in grams to milligrams.

(c) Step 3. Amount of concentrate (in milligrams) x average THC potency percentage of concentrate = preliminary amount of THC infused medicinal cannabis products (in milligrams).

(d) Step 4. Preliminary amount of THC infused medicinal cannabis products (in milligrams) / 5 = final amount of THC infused medicinal cannabis products (in milligrams).

(2) In Step 4 of the equivalency formula, the preliminary amount of THC infused medicinal cannabis products (in milligrams) is reduced by a factor of five (5) based on pharmacokinetic equivalency research showing one (1) milligram of THC in edible form is equivalent to approximately five (5) milligrams of THC in inhalable form.

(3) For example:

(a) 28 grams of raw plant material x 25% average THC potency = 7 grams of concentrate.

(b) 7 grams is equivalent to 7,000 milligrams.

(d) 4,900 milligrams / 5 = 980 milligrams of THC infused medicinal cannabis products.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing supply limits and an equivalency formula for medicinal cannabis. This administrative regulation establishes the supply limits and equivalency formula for the Kentucky Medical Cannabis Program.
History: 50 Ky.R. 2128; eff. 8-28-2024.

915 KAR 2:030 Written certifications {#sec-915-kar-2-030 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:030}

Section 1. Medicinal Cannabis Practitioners.

(1) The cabinet shall maintain a medicinal cannabis practitioner registry for the Kentucky Medical Cannabis Program as part of the state's designated electronic monitoring system.

(2) Medicinal cannabis practitioners shall register with the state's medicinal cannabis practitioner registry in accordance with this administrative regulation and shall properly enter written certifications and dosage recommendations for qualified patients into the registry.

(3) Prior to providing a patient with a written certification, a medicinal cannabis practitioner shall comply with KRS 218B.050(4).

(4) A medicinal cannabis practitioner shall comply with the respective administrative regulation promulgated by his or her state licensing board establishing professional standards for medicinal cannabis practitioners, 201 KAR 9:067 or 201 KAR 20:067, and shall be authorized to provide written certifications for use of medicinal cannabis to qualified patients by his or her state licensing board.

Section 2. Written Certification Form.

(1) When issuing a written certification for the use of medicinal cannabis to a patient, the medicinal cannabis practitioner shall use the form prescribed by the cabinet and available in the medicinal cannabis practitioner registry. The written certification form shall include:

(a) The medicinal cannabis practitioner's full name, license type (such as MD or APRN), license number, office address, telephone number, and email address;

(b) The date of the medicinal cannabis practitioner's examination of the qualified patient;

(d) If the qualified patient is a minor, the custodial parent or legal guardian's full name, date of birth, Social Security number, email address, and phone number;

(e) Identification of the diagnosed qualifying medical condition(s);

(f) Attestations that the medicinal cannabis practitioner has:

Established a bona fide practitioner-patient relationship with the patient;
Diagnosed the patient, or confirmed a diagnosis provided by another healthcare provider, with a qualifying medical condition for which the medicinal cannabis practitioner believes that the patient is likely to receive safe and effective therapeutic or palliative benefit from the use of medicinal cannabis;
Reviewed a report of information from the electronic monitoring system established pursuant to KRS 218A.202 related to the patient for a period of time that covers at least the twelve (12) months immediately preceding the date of the report;
Consulted with the patient, or the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor, with respect to the possible risks and side effects associated with medicinal cannabis, including possible interactions between medicinal cannabis and any other drug or medication that the patient is taking at that time; and
Obtained the consent of the patient's custodial parent or legal guardian responsible for providing consent to treatment if the patient is a minor; and

(g) The medicinal cannabis practitioner's signature and the date signed.

(2) An initial written certification shall be provided by the medicinal cannabis practitioner to the qualified patient during the course of an in-person examination. Subsequent written certifications for the purpose of renewing a registry identification card may be provided electronically or during the course of a telehealth consultation.

(3) A medicinal cannabis practitioner shall comply with the time frame established in KRS 218B.050(6)(d) to record the issuance of a written certification in the state's designated medicinal cannabis practitioner registry.

(4) For the purpose of initially applying for a registry identification card, an initial written certification shall be valid in accordance with KRS 218B.050(6)(c).

(5) Pursuant to KRS 218B.055(10), for the purpose of renewing a registry identification card, a written certification issued by a medicinal cannabis practitioner shall be valid if issued within sixty (60) days immediately preceding the date of a renewal application.

(6) When entering a written certification into the state's designated medicinal cannabis practitioner registry, a medicinal cannabis practitioner shall enter any recommendation or limitation as to the form and dosage of medicinal cannabis that can be dispensed to the registered qualified patient.

Section 3. Material Incorporated by Reference.

(1) "Written Certification Form", dated June 26, 2024, is incorporated by reference.

(2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Cabinet for Health and Family Services, Office of the Secretary, 275 East Main Street, 2nd Floor, Frankfort, Kentucky, 40621, Monday through Friday, 8:30 a.m. to 4:30 p.m.

History

RELATES TO: KRS 218A.202, Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations creating a standardized written certification form for use by medicinal cannabis practitioners. This administrative regulation establishes the written certification form for the Kentucky Medical Cannabis Program.
History: 50 Ky.R. 2130; 51 Ky.R. 74, 323; eff. 8-28-2024.

915 KAR 2:040 Procedures to publish list of varieties of medicinal cannabis {#sec-915-kar-2-040 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:040}

Section 1. List of Varieties or Strains of Medicinal Cannabis.

(1) Beginning January 1, 2026, the cabinet shall conduct regular surveys of licensed cultivators and producers in the Commonwealth to obtain:

(a) A current list of cannabis varieties or strains being grown and cultivated in the Commonwealth;

(b) The average total tetrahydrocannabinol (THC) in each variety or strain based on the respective certificates of analysis;

(d) The average terpenoid type and concentration in each variety or strain based on the respective certificates of analysis.

(2) Beginning January 1, 2026, the cabinet shall conduct regular surveys of licensed dispensaries in the Commonwealth to obtain a list of any varieties of medicinal cannabis or medicinal cannabis products requested by cardholders that are not available for sale in the Commonwealth.

(3) On or before December 1, 2026, the cabinet shall review, compile, and publish the information obtained from the surveys required by this section in print materials for cardholders available on the Web site for the Kentucky Medical Cannabis Program at https://kymedcan.ky.gov. Along with listing the cannabis varieties or strains being grown and cultivated in the Commonwealth, the printed materials may include information regarding:

(a) Types of cannabis;

(b) Types and general effects of THC;

(d) Types and general effects of terpenoids or terpenes;

(e) Potential side effects of medicinal cannabis use and consumption;

(f) Forms of medicinal cannabis and average activation times for different products;

(g) Dosage or serving size information;

(h) How to obtain appropriate services or treatment for medicinal cannabis abuse;

(i) How to dispose of unused medicinal cannabis; and

(j) Any other information that the cabinet deems appropriate for inclusion.

(4) The cabinet shall annually review and update the printed materials for cardholders, including the list of cannabis varieties or strains being grown and cultivated in the Commonwealth.

History

RELATES TO: KRS Chapter 218B
STATUTORY AUTHORITY: KRS 218B.140
NECESSITY, FUNCTION, AND CONFORMITY: KRS 218B.140 requires the Cabinet for Health and Family Services to promulgate administrative regulations establishing procedures to publish and annually update a list of cannabis varieties or strains that possess a low but effective level of tetrahydrocannabinol, including the substance cannabidiol. This administrative regulation establishes those procedures.
History: 50 Ky.R. 2132; 51 Ky.R. 324; eff. 8-28-2024.

Title 915 KAR — Cabinet for Health and Family Services - Office of the Secretary - Medicinal Cannabis Program

Chapter 1 General

915 KAR 1:001 Definitions for 915 KAR Chapter 1 {#sec-915-kar-1-001 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:001}

915 KAR 1:010 Initial and renewal applications for cannabis business licenses {#sec-915-kar-1-010 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:010}

915 KAR 1:020 Cannabis business licenses {#sec-915-kar-1-020 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:020}

915 KAR 1:030 Cultivator {#sec-915-kar-1-030 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:030}

915 KAR 1:040 Processor {#sec-915-kar-1-040 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:040}

915 KAR 1:050 Producer {#sec-915-kar-1-050 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:050}

915 KAR 1:060 Safety compliance facility {#sec-915-kar-1-060 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:060}

915 KAR 1:070 Dispensary {#sec-915-kar-1-070 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:070}

915 KAR 1:080 Transportation and delivery of medicinal cannabis {#sec-915-kar-1-080 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:080}

915 KAR 1:090 Advertising {#sec-915-kar-1-090 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:090}

915 KAR 1:100 Packaging and labeling of medicinal cannabis {#sec-915-kar-1-100 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:100}

915 KAR 1:110 Medicinal cannabis testing {#sec-915-kar-1-110 omnilex-key=us-ky-regs-official--title-915--915 KAR 1:110}

Chapter 2 Patients, Caregivers, and Practitioners

915 KAR 2:001 Definitions for 915 KAR Chapter 2 {#sec-915-kar-2-001 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:001}

915 KAR 2:010 Procedures for registry identification cards {#sec-915-kar-2-010 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:010}

915 KAR 2:020 Supply limits and equivalency formula {#sec-915-kar-2-020 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:020}

915 KAR 2:030 Written certifications {#sec-915-kar-2-030 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:030}

915 KAR 2:040 Procedures to publish list of varieties of medicinal cannabis {#sec-915-kar-2-040 omnilex-key=us-ky-regs-official--title-915--915 KAR 2:040}

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