856 IAC 2 — ARTICLE 2. CONTROLLED SUBSTANCES

TITLE 856 INDIANA BOARD OF PHARMACY

ARTICLE 2. CONTROLLED SUBSTANCES

Rule 1

856 IAC 2-1-1 856 IAC 2-1-1 Definitions

Rule 1. Definitions

856 IAC 2-1-1 Definitions

Authority: IC 35-48-3-1

Affected: IC 4-21.5; IC 35-48-2-1

Sec. 1. Definitions. As used herein, the following terms shall have the meanings specified:

(a) The term "Act" means the Indiana Uniform Controlled Substances Act of 1973. IC 1971, 35-24.1 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(b) The term "basic class" means, as to controlled substances listed in Schedules I and II [856 IAC 2-2-2 and 856 IAC 2-2-3] :

(1) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in Section 2.11(b) [856 IAC 2-2-2(b)] of this chapter;

(2) Each of the opium derivatives, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Section 2.11(c) [856 IAC 2-2-2(c)] of this part;

(3) Each of the hallucinogenic substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in Section 2.11(d) [856 IAC 2-2-2(d)] of this part;

(4) Each of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(i) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium;

(ii) Apomorphine;

(iii) Codeine;

(iv) Ethylmorphine;

(v) Hydrocodone;

(vi) Hydromorphone;

(vii) Metopon;

(viii) Morphine;

(ix) Oxycodone;

(x) Oxymorphone;

(xi) Thebaine;

(xii) Mixed alkaloids of opium listed in Section 2.12(b)(2) [856 IAC 2-2-3(b)(2)] of this part;

(xiii) Cocaine; and

(xiv) Ecgonine;

(5) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation, listed in Section 2.12(c) [856 IAC 2-2-3(c)] as amended, of this part;

(6) Methamphetamine, including salts, isomers, and salts of isomers.

(7) Amphetamine, its salts, optical isomers and salts of its optical isomers;

(8) Phenmetrazine and its salts; and

(9) Methylphenidate.

(c) The term "Administration" means the Drug Enforcement Administration, formerly the Bureau of Narcotics and Dangerous Drugs.

(d) The term "agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. It does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman.

(e) The term "controlled premises" means–

(1) Places where original or other records or documents required under the Act [IC 35-48] are kept or required to be kept, and

(2) Places including factories, warehouses, or other establishments, conveyances, where persons registered under the Act [IC 35-48] or exempted from registration under the Act [IC 35-48] may lawfully hold, manufacture, or distribute, dispense, administer, or otherwise dispose of controlled substances.

(f) The term "Administrator" means the Director of the Federal Drug Enforcement Administration who has been delegated authority under the Controlled Substances Act of 1970 (84 Stat. 1242; 21 U.S.C. 801) by the Attorney General of the United States (28 C.F.R. 0.100), as amended.

(g) The term "hearing" means any hearing held pursuant to the provisions of IC 1971, 4-22-1 through 4-22-1-30 [Repealed by P.L.18-1986, SECTION 2. See IC 4-21.5.] as amended and 4-22-2, for the purpose of granting, denying, or revoking, or suspending a registrant or application for registrant or a hearing amending these rules pursuant to IC 1971, 35-24.1 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(h) The term "individual practitioner" means a physician, dentist, veterinarian, or other individual licensed, registered or otherwise permitted by the State of Indiana or the United States, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

(i) The term "institutional practitioner" means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the state of Indiana or the United States, to dispense a controlled substance in the course of practice, but does not include a pharmacy.

(j) The term "person" includes any individual, corporation, government or governmental subdivision or agency, business, trust partnership, association or other legal entity.

(k) The term "pharmacist" means any practitioner licensed as a pharmacist by the State of Indiana to dispense controlled substances and shall include pharmacist interns licensed by the State of Indiana, to dispense controlled substances under the supervision of a pharmacist licensed by the State of Indiana.

(l) The term "prescription" means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).

(m) The terms "register" and "registration" refers only to registration required and permitted by IC 1971, 35-24.1-3-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(n) The term "registrant" means any person who is registered or exempted from registration pursuant to IC 1971, 35-24.1-3-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(o) Any term not defined in this section shall have the definition set forth in IC 1971, 35-24.1-1-1 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.01; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-1-2 856 IAC 2-1-2 Controlled substances advisory committee; function; hearings

856 IAC 2-1-2 Controlled substances advisory committee; function; hearings

Authority: IC 35-48-3-1

Affected: IC 4-21.5; IC 35-48-2-1

Sec. 2. Function. The Controlled Substances Advisory Committee shall serve as a consultative and advisory body to the Board in all matters relative to additions, deletions and transfers of substances to or among schedules of control established by IC 1971, 35-24.1 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

In addition, the advisory committee may, as representatives of the Board, conduct hearings regarding control of substances, and it shall, as representatives of the Board, conduct hearings and make recommended findings in matters affecting the denial, suspension, or revocation of registrations. All adjudicatory hearings shall be conducted in a manner consistent with the provision of IC 1971, 35-24.1-3-4 through IC 1971, 35-24.1-3-5 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48] , and IC 1971, 4-22-1 [Repealed by P.L.18-1986, SECTION 2. See IC 4-21.5.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.11; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-1-3 856 IAC 2-1-3 Meetings; organization

856 IAC 2-1-3 Meetings; organization

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 3. Meetings and Organization. The controlled substances advisory committee shall meet not later than sixty (60) days after the appointment of their entire membership and thereafter shall meet upon the request of the Board. The committees shall select, from among their members, a chairman, vice-chairman, and secretary who shall serve terms of one year from the date of selection. In any case in which a committee officer shall be unable to serve a full term, the committee shall select another to serve in his own right a full term.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.12; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-1-4 856 IAC 2-1-4 Duties of officers

856 IAC 2-1-4 Duties of officers

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 4. Duties of Officers. The chairman of the committee, or the vice-chairman in the absence of the chairman, shall preside at all meetings of the committee. In addition, the chairman or his designee shall preside over all hearings conducted by the committee on behalf of the Board.

The secretary of the committee shall be responsible for keeping the minutes of all meetings and he shall further be charged with the responsibility of assuring that a complete and accurate record is made of all hearings conducted before the committee. To this end, he may, with the consent of the Board, arrange for the attendance of such stenographers or court reporters as are necessary for the recording of such hearings.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.13; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-1-5 856 IAC 2-1-5 Rulemaking powers

856 IAC 2-1-5 Rulemaking powers

Authority: IC 35-48-3-1

Affected: IC 4-22-2; IC 35-48-2-1

Sec. 5. Rules of Conduct. The advisory committee may, with the approval of the Board, make such other rules regulating its conduct and procedure as are necessary and proper for the orderly conduct of its business.

All such rules, when they may affect procedure or substance of matters which may come before the Board for adjudication, after promulgation in accordance with IC 1971, 4-22-2 as amended, shall be in writing and shall be made available upon request to parties appearing before the committee.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.14; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-1-6 856 IAC 2-1-6 Recommendations and findings

856 IAC 2-1-6 Recommendations and findings

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 6. Recommendations and findings. Recommendations and findings to be in writing. Whenever, in the discharge of its duties, the advisory committee shall be required to make recommendations or findings upon matters heard before the committee, such recommendations to the Board shall be in writing and shall include a summary of relevant evidence, opinions, and laws upon which such recommendations or findings are based.

(Indiana Board of Pharmacy; Reg 28,Ch I,Sec 1.15; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 2

856 IAC 2-2-1 856 IAC 2-2-1 Controlled substances code numbers

Rule 2. Controlled Substances Code Number–Schedules I through IV

856 IAC 2-2-1 Controlled substances code numbers

Authority: IC 35-48-3-1

Affected: IC 35-48-3-1

Sec. 1. Controlled Substances Code Number. (a) Each controlled substance, or basic class thereof, listed in Schedules I through IV [856 IAC 2-2-2 – 856 IAC 2-2-5] has been assigned a "Controlled Substances Code Number" for purposes of identification of the substances or class on certain Certificates of Registration issued by the Indiana State Board of Pharmacy pursuant to Section 3.42 [856 IAC 2-3-19] of the Chapter. Certain applicants for registration must include the appropriate numbers on the application as required in Section 3.32(d) [856 IAC 2-3-13(d)] of this Chapter.

(b) Except as stated in paragraph (a) of this section, no applicant or registrant is required to use the Controlled Substances Code Number for any purpose.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.01; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-2 856 IAC 2-2-2 Schedule I

856 IAC 2-2-2 Schedule I

Authority: IC 35-48-2-14; IC 35-48-3-1

Affected: IC 35-48-2-4

Sec. 2. (a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the controlled substances code number set forth opposite it.

(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(1) Acetylmethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9601

(2) Allylprodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .9602

(3) Alphacetylmethadol (except levo-alphalmethadol also known as levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM). . . . 9603

(4) Alphameprodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . 9604

(5) Alphamethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . .9605

(6) Benzethidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 9606

(7) Betacetylmethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .9607

(8) Betameprodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . 9608

(9) Betamethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .. . . . .9609

(10) Betaprodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . 9611

(11) Clonitazene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 9612

(12) Dextromoramide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 9613

(13) Dextrorphan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 9614

(14) Diampromide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . 9615

(15) Diethylthiambutene. . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . .. . . . . . . . 9616

(16) Difenoxin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9168

(17) Dimenoxadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9617

(18) Dimepheptanol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 9618

(19) Dimethylthiambutene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9619

(20) Dioxaphetyl butyrate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9621

(21) Dipipanone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..9622

(22) Ethylmethylthiambutene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9623

(23) Etonitazene. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 9624

(24) Etoxeridine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9625

(25) Furethidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . ..9626

(26) Hydroxypethidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9627

(27) Ketobemidone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . .9628

(28) Levomoramide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9629

(29) Levophenacylmorphan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9631

(30) Morpheridine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9632

(31) Noracymethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .. . .9633

(32) Norlevorphanol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9634

(33) Normethadone. . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..9635

(34) Norpipanone. . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9636

(35) Phenadoxone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9637

(36) Phenampromide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9638

(37) Phenomorphan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9647

(38) Phenoperidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..9641

(39) Piritramide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9642

(40) Proheptazine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 9643

(41) Properidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9644

(42) Propiram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . .9649

(43) Racemoramide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9645

(44) Trimeperidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..9646

(c) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Acetrophine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9319

(2) Acetyldihydrocodeine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . 9051

(3) Benzylmorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9052

(4) Codeine methylbromide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9070

(5) Codeine-N-Oxide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .9053

(6) Cyprenorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9054

(7) Desomorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .. . .9055

(8) Dihydromorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .9145

(9) Drotebanol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .9335

(10) Etorphine (Except Hydrochloride Salt). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . 9056

(11) Heroin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .9200

(12) Hydromorphinol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9301

(13) Methyldesorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .9302

(14) Methylidihydromorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .9304

(15) Morphine methylbromide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .9305

(16) Morphine methylsufonate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .9306

(17) Morphine-N-Oxide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9307

(18) Myrophine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .. .9308

(19) Nicocodeine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . .9309

(20) Nicomorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . .. .9312

(21) Normorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. . . . . . . . . ..9313

(22) Pholcodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .9314

(23) Thebacon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . .. . . .9315

(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this subsection only, "isomer" includes the optical, position, and geometric isomers):

(1) 4-Bromo-2, 5-Dimethoxyamphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7391

Some trade or other names:

4-Bromo-2, 5-Dimethoxy-a-methylphenethylamine; 4-Bromo-2, 5-DMA

(2) 2, 5-Dimethoxyamphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. . . 7396

Some trade or other names:

2, 5-Dimethoxy-a-methylphenethylamine; 2,5-DMA

(3) 4-Methoxyamphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7411

Some trade or other names:

4-Methoxy-a-methylphenethylamine: Paramethoxyamphetamine: PMA

(4) 5-methoxy-3, 4-methylenedioxy amphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7401

(5) 4-methyl-2, 5-dimethoxyamphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 7395

Some trade and other names:

4-methyl-2,5-dimethoxy-a-methylphenethylamine: "DOM"; and "STP".

(6) 3, 4-methylenedioxy amphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7400

(7) 3, 4, 5-trimethoxy amphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7390

(8) Bufotenine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7433

Some trade and other names:

3-(B-Dimethylaminoethyl)-5-hydroxyindol; 3-(2-Dimethylaminoethyl)-5-indolo; N, N-dimenthylserotonin; 5-hydroxy-N, N-dimethyltryptamine; mappine.

(9) Diethyltryptamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7434

Some trade and other names: N, N-Diethyltryptamine, DET.

(10) Dimethyltryptamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . .7435

Some trade or other names: DMT

(11) Ibogaine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7260

Some trade and other names:

7-Ethyl-6, 6a, 7, 8, 9, 10, 12, 13-octahydro-2-methoxy-6, 9-methano-5H-pyrido (1', 2': 1, 2) azepino 4, 5-b) indole; tabernanthe iboga.

(12) Lysergic acid diethylamide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... . 7315

(13) Marihuana. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7360

(14) Mescaline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . 7381

(15) Peyote. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . 7415

Meaning all parts of the plant presently classified botanically as Lophophora Williamsii Lemaire, whether growing or not; the seeds thereof; any extract from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or extracts.

(Interprets 21 U.S.C. 812(c), Schedule I(c) (12))

(16) N-ethyl-3-piperidyl benzilate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7482

(17) N-methyl-3-piperidyl benzilate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7484

(18) Psilocybin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7437

(19) Psilocyn. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7438

(20) Tetrahydrocannabinols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . 7370

Synthetic equivalents of the substances contained in plant, or in the resinous extractives of Cannabis, sp. and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity such as the following:

Δ¹ cis or trans tetrahydrocannabinol, and their optical isomers.

Δ⁶ cis or trans tetrahydrocannabinol and their optical isomers.

Δ^{3, 4} cis or trans tetrahydrocannabinol, and its optical isomers.

(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions are covered.)

(21) Thiophene Analog of Phencyclidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .7470

Some trade or other names:

1-(1-(2-thienyl) cyclohexyl) piperidine); 2-Thienyl Analog of Phencyclidine, TPCP.

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Mecloqualone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2572

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.11; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed Jun 9, 1977, 8:55 a.m.: Unpublished; filed May 31, 1994, 5:00 p.m.: 17 IR 2335; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-3 856 IAC 2-2-3 Schedule II

856 IAC 2-2-3 Schedule II

Authority: IC 35-48-2-14; IC 35-48-3-1

Affected: IC 35-48-2-6

Sec. 3. (a) Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the controlled substances code number set forth opposite it.

(b) Substances, vegetable origin, or chemical synthesis. Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding naloxone and its salts and naltrexone and its salts but including the following:

(A) Raw opium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9600

(B) Opium extracts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9610

(C) Opium fluid extracts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9620

(D) Powdered opium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9639

(E) Granulated opium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9640

(F) Tincture of opium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9630

(G) Apomorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9030

(H) Codeine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9050

(I) Ethylmorphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9190

(J) Etorphine hydrochloride. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9059

(K) Hydrocodone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9193

(L) Hydromorphone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9194

(M) Metopon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..9260

(N) Morphine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9300

(O) Oxycodone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9143

(P) Oxymorphone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9652

(Q) Thebaine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 9333

(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subdivision (1), except that these substances shall not include the isoquinoline alkaloids of opium.

(3) Opium poppy and poppy straw (9650).

(4) Coca Leaves (9040) and salt, compound, derivative, or preparation of coca leaves, and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine (9041) or ecgonine (9180).

(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid, or powder form which contains the phenanthrine alkaloids of the opium poppy) 9670.

(c) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(1) Alphaprodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9010

(2) Anileridine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9020

(3) Benzitramide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . .9800

(4) Dihydrocodeine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9120

(5) Diphenoxylate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 9170

(6) Fentanyl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9801

(7) Isomethadone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . .9226

(8) Levo-alphacetylmethadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9648

Some trade and other names:

levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM.

(9) Levomethorphan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9210

(10) Levorphanol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .9220

(11) Metazocine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9240

(12) Methadone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9250

(13) Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-dyphenyl butane. . . . . . . . . . . . . . . . . . .. .9254

(14) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenyl-propane-carboxylic acid. . . . . . . . . . . . . .9802

(15) Pethidine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9230

(16) Pethidine-Intermediate-A,4-cyano-1- methyl-4-phenylpiperidine. . . . . . . . . . . . . . . . . . . . . . . . 9232

(17) Pethidine-Intermediate-B,ethyl-4-phenylpiperidine-4-carboxylate. . . . . . . . . . . . . . . . . . . . . . 9233

(18) Pethidine-Intermediate-C,1-methyl-4- phenylpiperidine-4-carboxylic acid. . . . . . . . . . . . . . . . . .. 9234

(19) Phenazocine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9715

(20) Piminodine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9730

(21) Racemethorphan. . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . 9732

(22) Racemorphan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9733

(d) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers. . . . . . . . . . . . . . . . . . 1100

(2) Methamphetamine, including its salts, isomers, and salts of isomers. . . . . . . . . . . . . . . . . . . . . 1105

(3) Phenmetrazine and its salts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1631

(4) Methylphenidate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1724

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Methaqualone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2565

(2) Amobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2125

(3) Secobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . .2315

(4) Pentobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2270

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.12; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed Jun 9, 1977, 8:55 a.m.: Unpublished; filed May 31, 1994, 5:00 p.m.: 17 IR 2336; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-4 856 IAC 2-2-4 Schedule III

856 IAC 2-2-4 Schedule III

Authority: IC 35-48-3-1

Affected: IC 35-48-2-8

Sec. 4. (a) Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.

(b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II, which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under 1308.32, and any other drug of the quantitative composition shown in that list for those drugs or that is the same, except that it contains a lesser quantity of controlled substances. . . . . . .1405

(2) Benzphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1228

(3) Chlorphentermine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1645

(4) Clortermine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 1647

(5) Mazindol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1605

(6) Phendimetrazine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1615

(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system:

(1) Any compound, mixture, or preparation containing:

(A) Amobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2125

(B) Secobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2315

(C) Pentobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2270

or any salt thereof and one (1) or more other active medicinal ingredient that are not listed in any schedule.

(2) Any suppository dosage form containing:

(A) Amobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2125

(B) Secobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2315

(C) Pentobarbital. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2270

or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository.

(3) Any substance that contains any quantity of a derivative of barbituric acid or any salt thereof. . 2100

(4) Chlorhexadol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . .2510

(5) Ketamine, its salts, isomers, and salts of isomers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7285

Some other names for ketamine: (-2(2-chlorophenyl) -2- (methylamino) - cyclohexanone

(6) Lysergic acid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7300

(7) Lysergic acid amide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7310

(8) Methyprylon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2575

(9) Sulfondiethylmethane. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2600

(10) Sulfonethylmethane. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . 2605

(11) Sulfonmethane. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2610

(d) Nalorphine (a narcotic drug). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9400

(e) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof:

(1) Not more than one and eight-tenths (1.8) grams of codeine, per one hundred (100) milliliters or not more than ninety (90) milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. . . . . . . . . . . . . . . . . . . . . . . 9803

(2) Not more than one and eight-tenths (1.8) grams of codeine, per one hundred (100) milliliters or not more than ninety (90) milligrams per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts. . . . . . . . . . . . . .. .9804

(3) Not more than three hundred (300) milligrams of dihydrocodeinone, per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium . . . .9805

(4) Not more than three hundred (300) milligrams of dihydrocodeinone, per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit, with one (1) or more active, nonnarcotic ingredients, in recognized therapeutic amounts . .. . . . . . . . . . 9806

(5) Not more than one and eight-tenths (1.8) grams of dihydrocodeine, per one hundred (100) milliliters or not more than ninety (90) milligrams per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts . . . . . . . . . . . . . . . . .9807

(6) Not more than three hundred (300) milligrams of ethylmorphine, per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts . . . . . . . . . . . . . . . . . 9808

(7) Not more than five hundred (500) milligrams of opium per one hundred (100) milliliters or per one hundred (100) grams or not more than twenty-five (25) milligrams per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts . . . .9809

(8) Not more than fifty (50) milligrams of morphine, per one hundred (100) milliliters or per one hundred (100) grams with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9810

(f) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any quantity of anabolic steroids, including its salts, isomers, and salts of isomers whenever the existence of such salts of isomers is possible within the specific chemical designation . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .4000

(g) For hallucinogenic substances, dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a United States Food and Drug Administration-approved drug product . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . .. . . .7369

(Some other names for dronabinol: (6aR-trans) - 6a, 7, 8, 10a - tetrahydro-6,6,9 - trimethyl - 3-pentyl- 6H - dibenzo[b,d]pyrano-1-ol, or (1) Δ⁹ - (trans) - tetrahydrocan-nabinol.)

(Indiana Board of Pharmacy; Reg 28, Ch II, Sec 2.13; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed Jun 9, 1977, 8:55 a.m.: Unpublished; filed May 26, 2000, 8:52 a.m.: 23 IR 2503; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-5 856 IAC 2-2-5 Schedule IV

856 IAC 2-2-5 Schedule IV

Authority: IC 35-48-3-1

Affected: IC 35-48-2-10

Sec. 5. (a) Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.

(b) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Barbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. .. 2145

(2) Chloral betaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. 2460

(3) Chloral hydrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . 2465

(4) Chlordiazepoxide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2744

(5) Clonazepam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .2737

(6) Clorazepate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 2768

(7) Diazepam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . 2765

(8) Ethchlorvynol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .2540

(9) Ethinamate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . 2545

(10) Flurazepam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2767

(11) Mebutamate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .2800

(12) Meprobamate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2820

(13) Methohexital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2264

(14) Methylphenobarbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 2250

(15) Oxazepam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .2835

(16) Paraldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2585

(17) Petrichloral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . .2591

(18) Phenobarbital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2285

(c) Fenfluramine. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible:

(1) Fenfluramine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . .1670

(d) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Diethylpropion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .1608

(2) Phentermine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1640

(3) Pemoline (including organometallic complexes and chelates thereof) . . . . . . . . . . . . . . . . . . . . 1530

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.14; filed Jul 9, 1974, 9:29 am: Unpublished; filed Jun 9, 1977, 8:55 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-6 856 IAC 2-2-6 Schedule V

856 IAC 2-2-6 Schedule V

Authority: IC 35-48-3-1

Affected: IC 35-48-2-12

Sec. 6. (a) Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.

(b) Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs or salts thereof, which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

(1) Not more than 200 milligrams of codeine, per 100 milliliters or per 100 grams.

(2) Not more than 100 milligrams of dihydrocodeine, per 100 milliliters or per 100 grams.

(3) Not more than 100 milligrams of ethylmorphine, per 100 milliliters or per 100 grams.

(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.

(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.15; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-7 856 IAC 2-2-7 Application for exception of stimulant or depression compound; revocation

856 IAC 2-2-7 Application for exception of stimulant or depression compound; revocation

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 7. Application for exception of a stimulant or depressant compound. (a) Any person seeking to have any compound, mixture, or preparation containing any depressant or stimulant substance listed in Chapter 2, Section 2.13(b) or (c) [856 IAC 2-2-4(b) or (c)] or in Section 2.14 [856 IAC 2-2-5] excepted from the application of all or any part of the Act [IC 35-48] pursuant to IC 1971, 35-24.1-2-8(e) or 10(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, may apply to the Indiana Board of Pharmacy for such exception.

(b) An application for an exception under this section shall be approved by the Board, provided that such application shall contain a copy of the Administration's approval for such request for an exception from the Federal Controlled Substances Act.

(c) Within a reasonable period of time after the receipt of an application for an exception under this section, the Indiana State Board of Pharmacy shall notify the applicant of its acceptance or non-acceptance of the application, and if not accepted, the reason therefor. The Indiana State Board of Pharmacy need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraph (b) of this section.

(d) The Indiana Board of Pharmacy may at any time revoke any exception granted pursuant to IC 1971, 35-24.1-2-8(e) or 10(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] , as amended, upon a finding that such exception from the Federal Controlled Substances Act was terminated, suspended or revoked. The revocation of the exception granted under this Act [IC 35-48] shall become effective upon the Board's notifying the person to whom such exception was granted by certified mail of such revocation.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.21; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-8 856 IAC 2-2-8 Excepted stimulant or depressant compounds

856 IAC 2-2-8 Excepted stimulant or depressant compounds

Authority: IC 35-48-3-1

Affected: IC 35-48-2-8; IC 35-48-2-10

Sec. 8. The Indiana Board of Pharmacy may except any compound, mixture, or preparation containing any depressant or stimulant substance listed in Section 2.13(b) or (c) [856 IAC 2-2-4(b) or (c)] , or in Section 2.14 [856 IAC 2-2-5] from the application of all or any part of the Act pursuant to IC 1971, 35-24.1-2-8(e) or 10(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, the drugs which were excepted by the Bureau or Administration on April 1, 1973 under section 202(d) of the Federal Controlled Substances Act (21 U.S.C. 812(d)) have been excepted by the Indiana State Board of Pharmacy from the application of IC 1971, 25-24.1-3, 6 and 8 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, and the application of Section 3.74(d) [856 IAC 2-3-33(d)] (rule) for administrative purposes only. The excepting of these drugs by the Indiana State Board of Pharmacy should not be construed as an adoption or rejection of the criteria by which these drugs were originally excepted. Any deviation from the quantitative composition of any of the listed drugs shall require a petition for exception in order for that drug to be excepted.

The following is a list of the excepted stimulant or depressant compounds under these regulations [856 IAC 2-2] .

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.22; filed Jul 9, 1974, 9:29 am: Unpublished; filed Jun 9, 1977, 8:55 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-9 856 IAC 2-2-9 Application for exclusion of stimulant or depression compound; revocation

856 IAC 2-2-9 Application for exclusion of stimulant or depression compound; revocation

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 9. Application for exclusion of a stimulant or depressant compound. (a) Any person seeking to have any non-narcotic substance which may, under the Federal Food, Drug, and Cosmetic Act or state law, be lawfully sold over-the-counter without a prescription, excluded from any schedule, pursuant to IC 1971, 35-24.1-2-1(g) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, may apply to the Indiana Board of Pharmacy for such exclusion.

(b) An application for an exclusion under this section shall be approved by the Board, provided that such application shall contain a copy of the Administration's approval for such request for an exclusion from the Federal Controlled Substances Act.

(c) Within a reasonable period of time after the receipt of an application for an exclusion under this section, the Indiana State Board of Pharmacy shall notify the applicant of its acceptance or non-acceptance of the application, and if not accepted, the reason therefor. The Indiana State Board of Pharmacy need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraph (b) of this section.

(d) The Indiana State Board of Pharmacy may at any time revoke any exclusion granted pursuant to IC 1971, 35-24.1-2-1(g) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] , as amended, upon a finding that such exclusion from the Federal Controlled Substances Act was terminated, suspended or revoked. The revocation of the exclusion granted under this Act [IC 35-48] shall become effective upon the board's notifying the person to whom such exclusion was granted by certified mail of such revocation.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.23; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-10 856 IAC 2-2-10 Excluded nonnarcotic substances, stimulant or depressant compounds

856 IAC 2-2-10 Excluded nonnarcotic substances, stimulant or depressant compounds

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 10. Excluded non-narcotic substances, stimulant, or depressant compounds. (a) The Indiana Board of Pharmacy may exclude any non-narcotic substance from a schedule if such substance may, under the Federal Food, Drug and Cosmetic Act or state law, be lawfully sold over-the-counter without a prescription pursuant to IC 1971, 35-24.1-2-1(g) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, the drugs which were excluded by the Bureau or Administration on January 1, 1974 under section 201(g)(1) of the Federal Controlled Substances Act (21 U.S.C. 811(g) (1)) have been excluded by the Indiana State Board of Pharmacy from the schedules of IC 1971, 35-24.1-2-4, 6, 8, 10, and 12 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] , as amended. The exclusion of these drugs by the Indiana State Board of Pharmacy should not be construed as an adoption or rejection of the criteria by which these drugs were originally excluded. Any deviation from the quantitative composition of any of the listed drugs shall require a petition for exclusion in order for that drug to be excluded. The following is a list of the presently excluded non-narcotic substances under these regulations.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.24; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-11 856 IAC 2-2-11 Exempt chemical preparations

856 IAC 2-2-11 Exempt chemical preparations

Authority: IC 35-48-3-1

Affected: IC 35-48-2-1

Sec. 11. Exempt Chemical Preparations. (a) The chemical preparations and mixtures specifically listed in subparagraph (b) of this Section have been exempted by the Indiana Board of Pharmacy from the application of IC 1971, 35-24.1-3-2, 3, 6 and 8 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, which preparation or mixture is intended for laboratory, industrial, educational or special research purposes and not for general administration to a human being or other animal. The exemption to be valid must be in strict compliance with the requirements imposed for the preparation or mixture prescribed in Part 1308, Section 1308.24 of Title 21 of the Code of Federal Regulations, effective January 1, 1973, and no exemption granted pursuant to this Section affects the criminal liability for illegal manufacture, distribution, or possession of controlled substances contained in the exempt chemical preparation. Distribution, possession and use of an exempt chemical preparation are lawful for registrants and non-registrants only as long as such distribution, possession or use is intended for laboratory, industrial or educational purposes and not for immediate or subsequent administration to a human being or other animal.

(b) The following preparations and mixtures in the form and quantity listed in the application submitted (indicated as the "date of application") are designated as exempt chemical preparations for the purposes set forth in this Section.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.25; filed Jul 9, 1974, 9:29 am: Unpublished; filed Jun 9, 1977, 8:55 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-12 856 IAC 2-2-12 Rulemaking hearings

856 IAC 2-2-12 Rulemaking hearings

Authority: IC 35-48-3-1

Affected: IC 4-22-2; IC 35-48-3-1

Sec. 12. Hearings for rule making. In any case where the Indiana Board of Pharmacy shall hold a hearing on the issuance, amendment, or repeal of rules pursuant to IC 1971, 35-24.1-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, the procedures for such hearing and accompanying proceedings shall be governed generally by the rule making procedures set forth in IC 1971, 4-22-2 as amended, and such procedures, if relating to standards and schedules, be of record in accordance with IC 1971, 35-24.1-2-1 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.31; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-13 856 IAC 2-2-13 Purpose of public hearings

856 IAC 2-2-13 Purpose of public hearings

Authority: IC 35-48-3-1

Affected: IC 35-48-3-1

Sec. 13. Purpose of hearing. Whenever proceedings are initiated pursuant to IC 1971, 35-24.1-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, of this chapter, the Indiana Board of Pharmacy shall hold a hearing of record for the purpose of receiving factual evidence and expert opinion regarding the issues involved in the issuance, amendment or repeal of a rule issuable pursuant to IC 1971, 35-24.1-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

On the date set for hearing any interested party in person or by attorney shall be afforded an adequate opportunity to participate in the formulation of the proposed rule or rules through the presentation of facts or argument or the submission of written data or views. All relevant matter presented shall be given full consideration by the Board.

The Board may adopt procedures in addition to those required by this Act [IC 35-48] including the holding of conferences and inviting and permitting the submission of suggestions, facts, argument and views of interested persons in advance of the drafting of the proposed rule or rules.

(Indiana Board of Pharmacy; Reg 28,Ch II,Sec 2.32; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-2-14 856 IAC 2-2-14 Exempt anabolic steroid products

856 IAC 2-2-14 Exempt anabolic steroid products

Authority: IC 35-48-2-14

Affected: IC 35-48-2

Sec. 14. The following anabolic steroid containing compounds, mixtures, or preparations have been exempted from this rule and are not controlled substances:

(Indiana Board of Pharmacy; 856 IAC 2-2-14; filed May 31, 1994, 5:00 p.m.: 17 IR 2337; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 3

856 IAC 2-3-1 856 IAC 2-3-1 Registration information furnished upon request

Rule 3. Registration Information–Special Instructions

856 IAC 2-3-1 Registration information furnished upon request

Authority: IC 35-48-3-1

Affected: IC 35-48-3-1

Sec. 1. Information; special instructions. Information regarding procedures under these rules and instructions supplementing these rules will be furnished upon request by writing to the Indiana State Board of Pharmacy.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.02; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-2 856 IAC 2-3-2 Persons required to register

856 IAC 2-3-2 Persons required to register

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 2. Persons required to register. Every person who manufactures, distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance shall obtain annually a registration unless exempted by law or pursuant to sections 3.14–3.17 [856 IAC 2-3-5 – 856 IAC 2-3-8] of this chapter. Only persons actually engaged in such activities are required to obtain registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration).

As soon after the effective date of these rules as is practicable, the Board shall issue a provisional certificate to all persons when in possession of a valid State of Indiana or Federal certificate of registration authorizing such persons to manufacture, distribute, dispense, prescribe or possess controlled substances. The provisional certificates shall be valid until the Board shall declare that applications for annual renewals shall begin and until such applications have been acted upon by the Board. During the first renewal period, when it is instituted, applications shall be required from all prospective registrants in alphabetically ordered increments according to a schedule to be adopted by the Board.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.11; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-3 856 IAC 2-3-3 Independent activities; separate registration required; exceptions

856 IAC 2-3-3 Independent activities; separate registration required; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3; IC 35-48-3-4

Sec. 3. Separate registration for independent activities. (a) The following groups of activities are deemed to be independent of each other:

(1) Manufacturing controlled substances;

(2) Distributing controlled substances;

(3) Dispensing controlled substances listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] ;

(4) Conducting research (other than research described in sub-paragraph (6) of this paragraph) with controlled substances listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] ;

(5) Conducting instructional activities with controlled substances listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] ;

(6) Conducting research with narcotic drugs listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] for the purpose of continuing the dependence on such drugs of a narcotic drug dependent person in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program pursuant to a Notice of Claimed Investigational Exemption for a New Drug approved by the Food and Drug Administration;

(7) Conducting research and instructional activities with controlled substances listed in Schedule I [856 IAC 2-2-2] ; and

(8) Conducting chemical analysis with controlled substances listed in any Schedule.

(b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities except as provided in this paragraph. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities:

(1) A person registered to manufacture any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture;

(2) A person registered to manufacture any controlled substance listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] shall be authorized to conduct chemical analysis and pre-clinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture;

(3) A person registered to conduct research with a basic class of controlled substance listed in Schedule I [856 IAC 2-2-2] shall be authorized to manufacture such class if and to the extent that such manufacture is set forth in a research protocol federally approved by the Drug Enforcement Administration and to distribute such class to other persons registered or authorized to conduct research with such class or registered or authorized to conduct chemical analysis with controlled substances;

(4) A person registered or authorized to conduct chemical analysis with controlled substances shall be authorized to manufacture such substances for analytical or instructional purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis or instructional activities or research with such substances and to persons exempted from registration pursuant to section 3.16 [856 IAC 2-3-7] , and to conduct instructional activities with controlled substances; and

(5) A person registered or authorized to conduct research (other than research described in paragraph (a)(6) of this section) with controlled substances listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] shall be authorized to conduct chemical analysis with controlled substances listed in those schedules in which he is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to distribute such substances to other persons registered or authorized to conduct chemical analysis, exempted from registration pursuant to Section 3.16 [856 IAC 2-3-7] , and to conduct instructional activities with controlled substances;

(6) A person registered to dispense controlled substances listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] shall be authorized to conduct research (other than research described in paragraph (a) (6) of this section) and to conduct instructional activities with those substances.

(7) A person registered as a manufacturer shall be authorized to conduct one, all or several of the activities and coincident activities enumerated and described in paragraphs (b)(1), (b)(2), (b)(3), (b)(4), and (b)(5) under a single registration if set forth in his application and pertaining to those controlled substances or schedules as set forth in his application. (For example, a manufacturer under a single registration may perform all or any of the following activities, by way of illustration and not limitation; (a) manufacture and distribute any controlled substance or basic class, (b) chemical analysis, (c) Schedule I [856 IAC 2-2-2] research pursuant to a federally approved protocol, (d) Schedule II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] research, and (e) instructional activity if set forth in his application and for those controlled substances or schedules as set forth for each activity.

(c) A single registration to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I [856 IAC 2-2-2] may conduct research with any substance listed in Schedule I [856 IAC 2-2-2] for which he has filed and had approved a research protocol, by the Federal Drug Enforcement Administration.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.12; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-4 856 IAC 2-3-4 Separate registrations for separate locations; exceptions

856 IAC 2-3-4 Separate registrations for separate locations; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 4. (a) A separate registration is required for each principal place of business or professional practice at one (1) general physical location where controlled substances are manufactured, distributed, dispensed, or possessed by a person.

(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register under IC 35-48-3-3.

(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders.

(3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.

(Indiana Board of Pharmacy; Reg 28, Ch III, Sec 3.13; filed Jul 9, 1974, 9:29 a.m.: unpublished; filed Feb 11, 1981, 9:05 a.m.: 4 IR 377; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; filed Jul 30, 2021, 3:42 p.m.: 20210825-IR-856200455FRA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-4.5 856 IAC 2-3-4.5 Registration of ambulance service providers

856 IAC 2-3-4.5 Registration of ambulance service providers

Authority: IC 35-48-3-1

Affected: IC 16-18-2; IC 35-48

Sec. 4.5. (a) The following definitions apply throughout this section:

(1)"Advanced emergency medical technician" has the meaning set forth in IC 16-18-2-6.5.

(2)"Ambulance" has the meaning set forth in IC 16-18-2-13.

(3)"Ambulance service provider" has the meaning set forth in 836 IAC 1-1-1.

(4)"Contracting hospital" means a licensed hospital pharmacy that has a written agreement with one (1) or more ambulance service providers to provide stocks of controlled substances to such providers.

(5)"Health care practitioner" means a licensed physician, physician assistant, or advanced nurse practitioner.

(6)"Medical director" has the meaning set forth in 836 IAC 1-1-1.

(7)"Paramedic" has the meaning set forth in IC 16-18-2-266.

(8)"Stock" means the controlled substances that are held by an ambulance service provider.

(9)"Sub-stock" means the controlled substances that are stored on a specific ambulance, or those controlled substances that are stored by an ambulance service provider that is owned or operated by, or utilizing a contract with, a hospital pharmacy.

(b) Each ambulance service provider that purchases, stores, or dispenses any controlled substance shall obtain a registration. A separate registration is required for each principal place of business where controlled substances are stored. A separate registration is not required for each ambulance owned or operated by the provider. Agents or employees of the provider are not required to register if such agent or employee is acting in the usual course of business or employment.

(c) A hospital pharmacy may, but is not required to:

(1) enter into a written agreement with an ambulance service provider to provide, sell or deliver stocks of controlled substances, to such provider for use in an ambulance; or

(2) enter into a written agreement with an ambulance service provider to act as an agent for such provider and supply a sub-stock of controlled substances for use in the provider's ambulances.

(d) A hospital pharmacy may, but is not required to, provide only those controlled substances approved by the medical director.

(e) All registrants under this section shall do the following:

(1) Purchase, possess, deliver or cause to be administered only those controlled substances approved by the medical director.

(2) Permit only a person who is approved by the medical director and is a licensed health care practitioner, advanced emergency medical technician, or paramedic to administer a controlled substance within the individual's approved scope of practice.

(f) A registrant owned or operated by a hospital may also:

(1) utilize the hospital pharmacy's registration for the delivery of controlled substances for use in any authorized ambulance;

(2) maintain the provider's controlled substances as part of the hospital's controlled substances sub-stock; and have [sic]

(3) the hospital act as the agent for the provider.

(g) Registrants shall ensure the following:

(1) Controlled substances shall be safeguarded properly and kept securely at the registered address on file with the board.

(2) All stocks or sub-stocks will be made available for inspection by authorized representatives of the board or emergency medical services commission staff.

(3) Access to controlled substances stocks shall be limited to the minimum number of individuals actually required to manage the administration, delivering, and handling of such controlled substances efficiently.

(4) A plan is submitted to the board for review and approval that details the location or locations of all stocks or sub-stocks, the safeguarding or access to, and security standards for all controlled substances.

(5) A quality assurance plan for the administration of controlled substances is submitted to the department.

(6) Only a reasonable quantity of controlled substances as approved by the medical director in the written medication list as required by 836 IAC 2-2-3 or listed in medical protocols is stored as sub-stocks.

(7) Monitor controlled substances for diversion and loss and report any initial loss or theft to the board within twenty-four (24) hours and any final determination of loss or theft within thirty (30) days.

(h) All controlled substances stock shall be secured and stored in accordance with sections 30, 31, and 33 of this rule.

(i) Registrants shall comply with the following storage and security requirements for sub-stocks in ambulances:

(1) Access to any sub-stock of controlled substances shall be limited to advanced emergency medical technicians or paramedics within their approved scope of practice and require at least two (2) locks with different keys or other secured access.

(2) Controlled substances must be secured in a locked box within a locked stationary cabinet under two (2) separate, secured, and independent locking systems.

(3) The key or keys to access the cabinet where controlled substances are stored must be maintained under the direct control of an advanced emergency medical technician or paramedic within their approved scope of practice.

(4) Controlled substances may be maintained in the direct possession and control of an advanced emergency medical technician or paramedic within their approved scope of practice while such individual is on duty; however, at no time shall controlled substances be carried in any personal automobile.

(5) A written change of shift inventory for any sub-stock shall be conducted when custody of controlled substances passes during a shift change.

(6) Alternative forms of securing or maintaining controlled substances in ambulances are subject to the approval of the board. The registrant must describe the alternative methods, state reasons why the alternative method is necessary and fully describe procedures for safeguarding and controlling controlled substances and limiting access to only authorized individuals.

(j) Controlled substances may only be administered pursuant to a licensed health care practitioner's order or a protocol authorized by the medical director. Controlled substances stock shall only be ordered or purchased upon authorization of the medical director.

(k) An individual making any administration of a controlled substance pursuant to an order or protocol shall make a record of the administration on all required forms of the registrant. Such documentation shall be made during or immediately following the run.

(l) The health care practitioner ordering or confirming the administration of a controlled substance shall make and maintain a record of such administration to include:

(1) health care practitioner's name and signature, or if administered under authorization of written medical protocol, noted as per protocol;

(2) date, time, and run identification;

(3) patient name;

(4) paramedic service provider name;

(5) advanced emergency medical technician or paramedic name;

(6) patient's chief complaint and presenting problem;

(7) name of controlled substance;

(8) dosage and route of administration;

(9) quantity administered; and

(10) receiving hospital name and record number.

(m) Each individual receiving an order or using a protocol to administer a controlled substance shall make a record of the administration to include:

(1) ordering physician identification;

(2) date, time, and run identification;

(3) patient name;

(4) paramedic service provider name;

(5) advanced emergency medical technician or paramedic name;

(6) patient's chief complaint and presenting problem;

(7) name of controlled substance;

(8) dosage and route of administration;

(9) quantity administered; and

(10) receiving hospital name and record number.

This record shall be the prehospital care report and any necessary supplement. A copy of the prehospital record shall be submitted to the receiving facility as well as a verbal report of the controlled substance administration.

(n) An individual administering a controlled substance shall maintain an administration inventory record for all controlled substances. This record shall be returned to the registrant before any controlled substances can be replenished.

(o) Registrants shall comply with all record keeping requirements as found in IC 35-48 and this article. Registrants shall also maintain the following records related to sub-stocks:

(1) Date and the amount of the controlled substance delivered to a sub-stock.

(2) Signature of the individual who delivered the controlled substance sub-stock.

(3) Signature of the individual receiving the controlled substance sub-stock. Only advanced emergency medical technicians and paramedics may receive sub-stock.

(4) Vehicle identification number or location of sub-stock.

(5) Remaining amount of controlled substance on hand.

(p) A separate record shall be maintained of all nonadministered losses from any stock or sub-stock.

(q) The registrant shall maintain a perpetual inventory for all controlled substances stock and sub-stock.

(r) Controlled substances may be destroyed or properly disposed of provided that:

(1) a notation is made on the administration record;

(2) the destruction is witnessed by a second licensed health care practitioner, advanced emergency medical technician, or paramedic, but if no such person is available, then witnessed by an emergency medical technician; and

(3) all destroyed or disposed product must be irretrievable and in accordance with current proper disposal practice.

(s) The medical director shall be accountable for education, protocol development, and oversight on the proper use and administration of the controlled substances and for maintaining a quality assurance plan and protocols.

(t) The registrant is responsible for the proper safeguarding, handling and accountability of controlled substances and for ensuring that all reports and reporting procedures are carried out. The registrant shall designate which executive or operating individual is responsible for controlled substance oversight.

(Indiana Board of Pharmacy; 856 IAC 2-3-4.5; filed Jul 30, 2021, 3:42 p.m.: 20210825-IR-856200455FRA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-5 856 IAC 2-3-5 Exemption of agents or employees; affiliated practitioners; paramedics

856 IAC 2-3-5 Exemption of agents or employees; affiliated practitioners; paramedics

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 5. (a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment.

(b) An individual practitioner (other than an intern, a resident, or a foreign-trained physician) who is an agent or employee of another practitioner registered to dispense controlled substances may, when acting in the usual course of his or her employment, administer and dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered himself or herself. For example, a pharmacist employed by a pharmacy need not be registered individually to fill a prescription for controlled substances in a pharmacy if so registered.

(c) An individual practitioner who is an intern, a resident, or a foreign-trained physician may dispense, administer, and prescribe controlled substances as follows under the registration of the hospital or other institution that is registered and by whom he or she is employed in lieu of being registered himself or herself, provided that:

(1) Such dispensing or prescribing is done in the usual course of his professional practice.

(2) Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she is practicing.

(3) The hospital or other institution by whom he is employed has determined that the individual practitioner is so permitted to dispense, administer, or prescribe drugs by the jurisdiction.

(4) Such individual practitioner is acting only within the scope of his employment with the hospital or institution.

(5) The hospital or other institution authorizes the intern, resident, or foreign-trained physician to dispense or prescribe under the hospital registration and designates a specific internal code number for each intern, resident, or foreign-trained physician so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution's Drug Enforcement Agency (DEA) registration number, preceded by a hyphen (e.g., AP 0123456-10 or AP 0123456-A12).

(6) A current list of internal codes and the corresponding individual practitioner is kept by the hospital or other institution and is made available to the public upon request for the purpose of verifying the authority of the prescribing individual practitioner.

(Indiana Board of Pharmacy; Reg 28, Ch III, Sec 3.14; filed Jul 9, 1974, 9:29 a.m.: unpublished; filed Feb 11, 1981, 9:05 a.m.: 4 IR 378; errata, 4 IR 536; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; filed Jul 30, 2021, 3:42 p.m.: 20210825-IR-856200455FRA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-6 856 IAC 2-3-6 Exemption of military or public health service personnel

856 IAC 2-3-6 Exemption of military or public health service personnel

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 6. Exemption of certain military and other personnel. (a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or Public Health Service who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his official duties. Such officials shall follow procedures set forth in Part 6 [856 IAC 2-6] of this chapter regarding prescriptions, but shall state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his Social Security identification number.

(b) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.15; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-7 856 IAC 2-3-7 Exemption of law enforcement officers; registration of law enforcement laboratories

856 IAC 2-3-7 Exemption of law enforcement officers; registration of law enforcement laboratories

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 7. Exemption of law enforcement officials. (a) The requirement of registration is waived for the following persons in the circumstances described in this section:

(1) Any officer or employee of the Drug Enforcement Administration, any officer of the U.S. Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other Federal officer who is lawfully engaged in the enforcement of any Federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his official duties; and

(2) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his official duties.

(b) Any official exempted by this section may, when acting in the course of his official duties, possess any controlled substance and distribute any such substance to any other official who is also exempted by this section and acting in the course of his official duties.

(c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with IC 1971, 35-24.1-5-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, or in the course of any criminal investigation involving the person from whom the substance was procured.

(d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories must obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in IC 1971, 35-24.1-5-6(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended. For the purpose of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.16; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-8 856 IAC 2-3-8 Exemption of civil defense officials

856 IAC 2-3-8 Exemption of civil defense officials

Authority: IC 35-48-3-1

Affected: IC 35-48-3-3

Sec. 8. Exemption of civil defense officials. (a) The requirement of registration is waived for any offical of a civil defense or disaster relief organization who, in the course of his official duties, is authorized to:

(1) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or

(2) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the U.S. General Services Administration and in accordance with the rules of the U.S. Office of Emergency Preparedness.

(b) The requirement of registration is waived for any official of a civil defense or disaster relief organization during a state of emergency or disaster within his jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his official duties during such emergency or disaster, is authorized to:

(1) Dispense controlled substances; or

(2) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form," as described in this section.

(c) Civil Defense Emergency Order Forms shall be furnished by the U.S. Office of Emergency Preparedness and will contain the name of the civil defense or disaster relief organization. Such forms may be used and are valid only during a state of emergency or disaster proclaimed by the President or by a concurrent resolution of the Congress for the area in which the organization using such forms has civil defense or disaster relief jurisdiction, who shall state his position and the nature and legal designation of the emergency or disaster. Such forms may be filled by any person registered under the Act [IC 35-48] . The Organization shall, upon the execution of a Civil Defense Emergency Order Form, be deemed to be registered under the Act [IC 35-48] for purposes or recordkeeping pursuant to Part 4 [856 IAC 2-4] .

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.17; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-9 856 IAC 2-3-9 Registration fees

856 IAC 2-3-9 Registration fees

Authority: IC 25-26-13-4

Affected: IC 25-26-13-4

Sec. 9. (a) For each registration or reregistration to manufacture controlled substances, the registrant shall pay a fee of one hundred dollars ($100).

(b) For each registration or reregistration to distribute controlled substances, the registrant shall pay a fee of one hundred dollars ($100).

(c) For each registration or reregistration to dispense or to conduct research or instructional activities with controlled substances listed in 856 IAC 2-2-3 through 856 IAC 2-2-6, the registrant shall pay a fee of one hundred dollars ($100).

(d) For each registration or reregistration to conduct research or instructional activities with controlled substances listed in 856 IAC 2-2-2, the registrant shall pay a fee of one hundred dollars ($100).

(e) For each registration or reregistration to conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay a fee of one hundred dollars ($100).

(f) For each registration or reregistration for a practitioner seeking to prescribe, administer, or dispense controlled substances, the registrant shall pay a fee of sixty dollars ($60).

(Indiana Board of Pharmacy; Reg 28, Ch III, Sec 3.21; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed Jul 8, 1981, 9:00 a.m.: 4 IR 1499; filed Jul 20, 1984, 10:00 a.m.: 7 IR 2379; filed Aug 21, 1986, 10:30 a.m.: 10 IR 63; filed Jun 6, 1996, 9:00 a.m.: 19 IR 3106; readopted filed Oct 17, 2001, 3:25 p.m.: 25 IR 940; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-10 856 IAC 2-3-10 Time and method of payment; refund (Repealed)

856 IAC 2-3-10 Time and method of payment; refund (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Nov 30, 2001, 11:00 a.m.: 25 IR 1344)

856 IAC 2-3-11 856 IAC 2-3-11 Persons exempt from fee

856 IAC 2-3-11 Persons exempt from fee

Authority: IC 35-48-3-1

Affected: IC 35-48-3-1

Sec. 11. Persons exempt from fee. (a) The Indiana State Board of Pharmacy shall exempt from payment of a fee for registration or re-registration the following persons:

(1) Any official or agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who or which is authorized to procure or purchase controlled substances for official use; and

(2) Any official, employee, or other civil officer or agency of the United States, or any State, or any political subdivision or agency thereof, who or which is authorized to purchase controlled substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct research, instructional activities, or chemical analysis with such substances, or any combination thereof, in the course of his or its official duties or employment.

(b) In order to claim exemption from payment of a registration or re-registration fee, the registrant shall have completed the certification on the appropriate form, wherein the registrant's superior (if an individual) or officer (if an agency) certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess, or handle controlled substances.

(c) Exemption from payment of a registration or re-registration fee does not relieve the registrant of any other requirements or duties prescribed by law.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.23; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-12 856 IAC 2-3-12 Time for registration or re-registration application

856 IAC 2-3-12 Time for registration or re-registration application

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 12. Time for application for registration; expiration date. (a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted by the Indiana Board of Pharmacy.

(b) Any person who is registered may apply to be re-registered not more than 60 days, before the expiration date his registration.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.31; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-13 856 IAC 2-3-13 Application forms; reregistration forms

856 IAC 2-3-13 Application forms; reregistration forms

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 13. (a) If any person is required to be registered, and is not so registered and is applying for registration, the following apply:

(1) To manufacture and perform other coincident activities (see 856 IAC 2-3-3(b)(7) [section 3(b)(7) of this rule] ) with controlled substances, he or she shall apply on Form CSR-1A.

(2) To dispense, or to conduct research (other than research described in 856 IAC 2-3-3(a)(6) [section 3(a)(6) of this rule] ) with, or to conduct instructional activities with, controlled substances listed in Schedules II through V under 856 IAC 2-2-3 through 856 IAC 2-2-6, he or she shall apply on Form CSR-1.

(3) To conduct research with narcotic drugs listed in Schedules II through V under 856 IAC 2-2-3 through 856 IAC 2-2-6, as described in 856 IAC 2-3-3(a)(6) [section 3(a)(6) of this rule] , he or she shall apply on Form CSR-1.

(4) To conduct research with controlled substances listed in Schedule I under 856 IAC 2-2-2, he or she shall apply on Form CSR-1 in accordance with an approved Schedule I under 856 IAC 2-2-2 research protocol. Such protocol shall be subject to inspection by the Indiana board of pharmacy.

(5) To conduct instructional activities with controlled substances listed in Schedule I under 856 IAC 2-2-2, he or she shall apply as a researcher on Form CSR-1 with two (2) copies of a statement describing the nature, extent, and duration of such instructional activities attached to the form.

(6) To conduct chemical analysis with controlled substances listed in any schedule, he or she shall apply on Form CSR-1.

(7) To distribute controlled substances, he or she shall apply on Form CSR-1.

(b) If any person is registered and is applying for reregistration, the following apply:

(1) To manufacture and perform other coincident activities (see 856 IAC 2-3-3(b)(7) [section 3(b)(7) of this rule] ), with controlled substances, he or she shall apply on Form CSRII-A.

(2) To dispense, or to conduct research (other than research described in 856 IAC 2-3-3(a)(6) [section 3(a)(6) of this rule] ) with, or to conduct instructional activities with, controlled substances listed in Schedules II through V under 856 IAC 2-2-3 through 856 IAC 2-2-6, he or she shall apply on Form CSR-II.

(3) To conduct research with narcotic drugs listed in Schedules II through V under 856 IAC 2-2-3 through 856 IAC 2-2-6, as described in 856 IAC 2-3-3(a)(6) [section 3(a)(6) of this rule] , he or she shall apply on Form CSR-II.

(4) To continue to conduct research with controlled substances listed in Schedule I under 856 IAC 2-2-2 under one (1) or more approved research protocols, by the Drug Enforcement Administration, he or she shall apply on Form CSR-II.

(5) To continue to conduct instructional activities with controlled substances listed in Schedule I under 856 IAC 2-2-2 under one (1) or more approved instructional statements, he or she shall apply as a researcher on Form CSR-II.

(6) To conduct chemical analysis with controlled substances listed in any schedule, he or she shall apply on Form CSR-II.

(7) To distribute controlled substances, he or she shall apply on Form CSR-II.

(c) Applications for registration may be obtained by writing to the controlled substance division of the Indiana board of pharmacy. Applications for reregistration will be mailed, as applicable, to each registered person approximately sixty (60) days before the expiration date of his or her registration; if any registered person does not receive such forms within forty-five (45) days before the expiration date of his or her registration, he or she must promptly give notice of such fact and request such forms by writing to the controlled substance division of the Indiana board of pharmacy.

(d) Each application for registration to handle any basic class of controlled substance listed in Schedule I under 856 IAC 2-2-2 (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in Schedule II under 856 IAC 2-2-3, or to conduct research with any narcotic controlled substance listed in Schedule II under 856 IAC 2-2-3, shall include the controlled substances code number, as set forth in Part I [856 IAC 2-1] , for each basic class or substance to be covered by such registration.

(e) Each application shall include all information called for on the form unless the item is not applicable, in which case this fact shall be indicated.

(f) Each application, attachment, or other document filed as part of an application shall be signed by:

(1) the applicant, if an individual;

(2) a partner of the applicant, if a partnership; or

(3) an officer or authorized representative of the applicant, if a corporation, corporate division, association, trust, or other entity.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.32; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 30, 2001, 11:00 a.m.: 25 IR 1342; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-14 856 IAC 2-3-14 Filing of application; joint filing (Repealed)

856 IAC 2-3-14 Filing of application; joint filing (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Nov 30, 2001, 11:00 a.m.: 25 IR 1344)

856 IAC 2-3-15 856 IAC 2-3-15 Acceptance for filing; defective applications; requests for additional information (Repealed)

856 IAC 2-3-15 Acceptance for filing; defective applications; requests for additional information (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Nov 30, 2001, 11:00 a.m.: 25 IR 1344)

856 IAC 2-3-16 856 IAC 2-3-16 Additional information; failure to supply

856 IAC 2-3-16 Additional information; failure to supply

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 16. Additional information. The Indiana State Board of Pharmacy may require an applicant to submit such documents or written statements of fact relevant to the application as the Board deems necessary and as provided by IC 1971, 35-24.1-3-3(a) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable period of time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Indiana State Board of Pharmacy in granting or denying the application.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.35; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-17 856 IAC 2-3-17 Amendment or withdrawal of application

856 IAC 2-3-17 Amendment or withdrawal of application

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 17. Amendments to and withdrawal of applications. An application may be amended or withdrawn without permission of the Indiana Board of Pharmacy at any time.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.36; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-18 856 IAC 2-3-18 Inspection and review of application by board

856 IAC 2-3-18 Inspection and review of application by board

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 18. Administrative review generally. The Indiana Board of Pharmacy may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to IC 1971, 35-24.1-5-2 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended. The Indiana Board of Pharmacy shall review the application for registration and other information regarding an applicant in order to determine whether the applicable standards of IC 1971, 35-24.1-3 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, have been met by the applicant.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.41; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-19 856 IAC 2-3-19 Certificate of registration; denial of registration

856 IAC 2-3-19 Certificate of registration; denial of registration

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 19. Certificate of registration; denial of registration. (a) The Indiana State Board of Pharmacy shall issue a Certificate of Registration Form CSR-3 to an applicant if the issuance of registration or re-registration is required under the applicable provisions of IC 1971, 35-24.1-3 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended. In the event that the issuance of registration or re-registration is not required, the Indiana State Board of Pharmacy may deny the application. Before denying any application, the Indiana State Board of Pharmacy shall issue an order to show cause pursuant to Section 3.46 [856 IAC 2-3-23] and, if requested by the applicant, shall hold a hearing on the application pursuant to Section 3.51, through Section 3.53 [856 IAC 2-3-24 – 856 IAC 2-3-26] .

(b) The Certificate of Registration shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Controlled Substances Code Number (as set forth in Part 2 [856 IAC 2-2] of this Act) of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall maintain the Certificate of Registration in a readily retrievable manner and shall permit inspection of the Certificate of Registration and shall permit inspection of the certificate by any official, agent, or employee of the Board or any agency engaged in enforcement of laws relating to controlled substances.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.42; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-20 856 IAC 2-3-20 Suspension or revocation of registration

856 IAC 2-3-20 Suspension or revocation of registration

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 20. Suspension or revocation of registration. (a) The Indiana Board of Pharmacy may suspend any registration pursuant to IC 1971, 35-24.1-3-4 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, for any period of time he determines.

(b) The Indiana Board of Pharmacy may revoke any registration pursuant to IC 1971, 35-24.1-3-4 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(c) Before revoking or suspending any registration, the Indiana Board of Pharmacy shall issue an order to show cause, such order shall be sent by certified mail to address of the registrant, advising registrant of his rights to a hearing, Form CSR-4, pursuant to section 3.46 [856 IAC 2-3-23] . Notwithstanding the requirements of this section, however, the Indiana Board of Pharmacy may suspend any registration pending a final order pursuant to section 3.44 [856 IAC 2-3-21] .

(d) Upon service of the final order of the Indiana Board of Pharmacy following a hearing or waiver thereof suspending or revoking registration, the registrant shall immediately deliver his Certificate of Registration to the Indiana Board of Pharmacy. Also, upon service of the final order of the Indiana Board of Pharmacy suspending or revoking registration, the registrant shall, as instructed by the Indiana Board of Pharmacy:

(1) Deliver all controlled substances in his possession to the Indiana Board of Pharmacy or to authorized agents of the Indiana Board of Pharmacy; or

(2) Place all controlled substances in his possession under seal as described in IC 1971, 35-24.1-3-4(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(e) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration to the Indiana Board of Pharmacy. Also, the registrant shall, as instructed by the Indiana Board of Pharmacy:

(1) Deliver to the Indiana Board of Pharmacy or to authorized agents of the Indiana Board of Pharmacy all of the particular controlled substance or substances affected by the revocation or suspension which are in his possession; or

(2) Place all of such substances under seal as described in IC 1971, 35-24.1-3-4(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.43; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-21 856 IAC 2-3-21 Suspension pending final order

856 IAC 2-3-21 Suspension pending final order

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 21. Suspension of registration pending final order. (a) The Indiana Board of Pharmacy may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where it finds that there is an imminent danger to the public health or safety. If the Indiana Board of Pharmacy so suspends, it shall serve with the order to show cause pursuant to section 3.46 [856 IAC 2-3-23] an order of immediate suspension which shall contain a statement of its findings regarding the danger to public health or safety.

(b) Upon service of the order of immediate suspension, the registrant shall promptly return his Certificate of Registration to the Indiana Board of Pharmacy. Also, upon service of the order of the Indiana Board of Pharmacy immediately suspending registration, the registrant shall, as instructed by the Indiana Board of Pharmacy:

(1) Deliver all affected controlled substances in his possession to the Indiana Board of Pharmacy or to authorized agents of the Indiana Board of Pharmacy; or

(2) Place all of such substances under seal as described in IC 1971, 35-24.1-3-4(c) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(c) Any suspension shall continue in effect until the conclusion of all preceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Indiana Board of Pharmacy or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his registration at a time earlier than specified in the order to show cause pursuant to section 3.46 [856 IAC 2-3-23] , which request shall be granted by the Indiana Board of Pharmacy who shall fix a date for such hearing as early as reasonably possible.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.44; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-22 856 IAC 2-3-22 Extension of registration pending re-registration order

856 IAC 2-3-22 Extension of registration pending re-registration order

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 22. Extension of registration pending final order. In the event that an applicant for re-registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for re-registration at least 30 days before the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Indiana Board of Pharmacy so issues its final order. The Indiana Board of Pharmacy may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for re-registration at least 30 days before expiration of the existing registration, with or without request by the registrant, if the Indiana Board of Pharmacy finds that such extension is not inconsistent with the public health and safety.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.45; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-23 856 IAC 2-3-23 Order to show cause

856 IAC 2-3-23 Order to show cause

Authority: IC 35-48-3-1

Affected: IC 35-48-3-5

Sec. 23. Order to show cause. (a) If, upon examination of the application for registration from any applicant and other information regarding the applicant, the Indiana Board of Pharmacy is unable to make the determinations required by the applicable provisions of IC 1971, 35-24.1-3-3 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] , as amended, to register the applicant, the Indiana Board of Pharmacy shall serve upon the applicant an order to show cause why the registration should not be denied.

(b) If, upon information regarding any registrant, the Indiana Board of Pharmacy determines that the registration of such registrant is subject to suspension or revocation pursuant to IC 1971, 35-24.1-3-4 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] , as amended, the Indiana Board of Pharmacy shall serve upon the registrant an order to show cause why a registration should not be revoked or suspended.

(c) The order to show cause shall call upon the applicant or registrant to appear before the Indiana Board of Pharmacy at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.

(d) The Indiana Board of Pharmacy shall hold a hearing at the time and place stated in the order, pursuant to section 3.51 [856 IAC 2-3-24] .

(e) When authorized by the section 3.51 [856 IAC 2-3-24] any agent of the Indiana Board of Pharmacy may serve the order to show cause.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.46; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-24 856 IAC 2-3-24 Evidentiary hearing

856 IAC 2-3-24 Evidentiary hearing

Authority: IC 35-48-3-1

Affected: IC 35-48-3-6

Sec. 24. The controlled substances advisory committee shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.51; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 30, 2001, 11:00 a.m.: 25 IR 1343; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-25 856 IAC 2-3-25 Hearing procedures

856 IAC 2-3-25 Hearing procedures

Authority: IC 35-48-3-1

Affected: IC 4-21.5; IC 35-48-3-6

Sec. 25. Hearing for granting, denial, revocation, or suspension of application. (a) In any case where the advisory committee shall hold a hearing on any registration or application therefor, the procedures for such hearing shall be governed generally by the adjudication procedures of IC 1971, 4-22-1-1 to 4-22-1-30 [Repealed by P.L.18-1986, SECTION 2. See IC 4-21.5.] , as amended, and by sections 3.52-3.53 [this section and 856 IAC 2-3-26] .

(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act [IC 35-48] or any other law of this State.

(c) At any such hearing the advisory committee shall designate one of its members as presiding officer.

(d) At any such hearing a quorum of the advisory committee consisting of a majority of its membership shall hear the evidence and the disputed issues of law and they shall after the conclusion of the hearing, prepare for the Board recommended findings, facts, and conclusions of law.

(e) The committee's recommended findings and facts and conclusions of law shall be acted on by the Board in the manner required by IC 1971, 4-22-1 [Repealed by P.L.18-1986, SECTION 2. See IC 4-21.5.] .

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.52; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-26 856 IAC 2-3-26 Modification or waiver of rules

856 IAC 2-3-26 Modification or waiver of rules

Authority: IC 35-48-3-1

Affected: IC 35-48-3-6

Sec. 26. Waiver or modification of rules.The presiding officer at the advisory committee hearings or of the Indiana Board of Pharmacy (with respect to matters pending before him) may modify or waive any rule in this part by notice in advance of the hearing, if he determines than no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served and if all parties consent. Such notice of modification or waiver shall be made a part of the record of the hearing.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.53; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-27 856 IAC 2-3-27 Modification of registration

856 IAC 2-3-27 Modification of registration

Authority: IC 35-48-3-1

Affected: IC 35-48-3-6

Sec. 27. Modification in registration. Any registrant may apply to modify his registration to authorize the handling of additional controlled substances or to change his name or address by submitting a letter of request to the Indiana Board of Pharmacy. The letter shall contain the registrant's name, address, registration number, and the substances and/or schedule to be added to his registration or the name or address and shall be signed by the same person who signed the most recent application for registration or re-registration. If the registrant is seeking to handle additional controlled substances listed in Schedule I [856 IAC 2-2-2] for the purpose of research or instructional activities, a Federally approved research protocol describing each research project involving the additional substances shall be subject to inspection by the Indiana Board of Pharmacy or he shall attach two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate. No fee shall be required to be paid for the modification. The request for modification shall be handled in the same manner as an application for registration.

If the modification of registration is approved, the Indiana Board of Pharmacy shall issue a new certificate of registration to the registrant, who shall maintain it with the old certificate of registration until the expiration date.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.61; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-28 856 IAC 2-3-28 Termination of registration; notice to board

856 IAC 2-3-28 Termination of registration; notice to board

Authority: IC 35-48-3-1

Affected: IC 35-48-3-6

Sec. 28. Termination of registration. The registration of any person shall terminate if and when such person dies, ceases legal existence, or discontinues business or professional practice. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Indiana Board of Pharmacy promptly of such fact.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.62; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-29 856 IAC 2-3-29 Transfer of registration

856 IAC 2-3-29 Transfer of registration

Authority: IC 35-48-3-1

Affected: IC 35-48-3-6

Sec. 29. Transfer of registration. No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the Indiana Board of Pharmacy may specifically designate and then only pursuant to its written consent.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.63; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-30 856 IAC 2-3-30 Security requirements; approval of security system

856 IAC 2-3-30 Security requirements; approval of security system

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 30. Security requirements generally. (a) All applicants and registrants shall provide and maintain effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Indiana Board of Pharmacy shall use the security requirements set forth in Sections 3.72-3.76 [856 IAC 2-3-31 – 856 IAC 2-3-35] as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in Sections 3.72 [856 IAC 2-3-31] , 3.73 [856 IAC 2-3-32] , and 3.75 [856 IAC 2-3-34] may be used in lieu of the materials and construction described in those sections.

(b) Substantial compliance with the standards set forth in Sections 3.72-3.76 [856 IAC 2-3-31 – 856 IAC 2-3-35] may be deemed sufficient by the Indiana Board of Pharmacy after evaluation of the overall security system and needs of a registrant or applicant. In evaluating the overall security system of a registrant or applicant, the Indiana Board of Pharmacy may consider any of the following factors as it may deem relevant to the need for strict compliance with security requirements:

(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);

(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units usable powders or nonusable powders);

(3) The quantity of controlled substance handled;

(4) The location of the premises and the relationship such location bears on security needs;

(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;

(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;

(7) The type of closures on vaults, safes, and secure enclosures;

(8) The adequacy of key control systems and/or combination lock control systems;

(9) The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources;

(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;

(11) The adequacy of supervision over employees having access to manufacturing and storage areas;

(12) The procedures for handling business guests, visitors, maintenance personnel, and non-employee service personnel;

(13) The availability of local police protection or of the registrant's or applicant's security personnel, and;

(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.

(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a non-controlled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Sections 3.72-3.76 [856 IAC 2-3-31 – 856 IAC 2-3-35] when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.

(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Sections 3.72-3.76 [856 IAC 2-3-31 – 856 IAC 2-3-35] may submit any plans, blueprints, sketches or other materials regarding the proposed security system to the Indiana Board of Pharmacy.

(e) Approval by the Drug Enforcement Administration of any security system, proposed security system, plans, blueprints, sketches or other material as being in substantial compliance with the requirements as set forth in 301.72-301.76 of Title 21 of the Code of Federal Regulations shall be deemed in compliance with Sections 3.71 through 3.75 [856 IAC 2-3-30 – 856 IAC 2-3-34] of these regulations, where applicable.

(f) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 20, 1971, shall be deemed to comply substantially with the standards set forth in Sections 3.71 [this section] , 3.72 [856 IAC 2-3-31] , 3.73 [856 IAC 2-3-32] , and 3.75 [856 IAC 2-3-34] .

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.71; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-31 856 IAC 2-3-31 Storage areas; security controls for nonpractitioners

856 IAC 2-3-31 Storage areas; security controls for nonpractitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 31. Physical security controls for nonpractitioners: Storage Areas. (a) Schedules I and II [856 IAC 2-2-2 and 856 IAC 2-2-3] . Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedule I or II [856 IAC 2-2-2 or 856 IAC 2-2-3] shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe or steel cabinet.

(i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques.

(ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and

(iii) Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Indiana Board of Pharmacy or the Drug Enforcement Administration may approve.

(2) A vault constructed before, or under construction on October 1, 1973, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or

(3) A vault constructed after October 1, 1973:

(i) The walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2-inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;

(ii) The door and frame unit of which vault shall conform to the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;

(iii) Which vault, if operations require it to remain open for frequent access, is equipped with "day-gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;

(iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or State police agency which has a legal duty to respond or a 24-hour control station operated by the registrant or such other protection as the Indiana Board of Pharmacy or the Drug Enforcement Administration may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;

(v) The door of which vault is equipped with contact switches; and

(vi) Which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Indiana Board of Pharmacy or the Drug Enforcement Administration.

(b) Schedules III, IV, and V [856 IAC 2-2-4 – 856 IAC 2-2-6] . Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedules III, IV, and V [856 IAC 2-2-4 – 856 IAC 2-2-6] shall be stored in one of the following secure storage areas:

(1) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a)(1) of this section;

(2) A vault which complies with the requirements set forth in either paragraph (a)(2) or (3) of this section or

(3) A building or area located within a building, which building or area:

(i) Has walls or perimeter fences of sufficient height and construction to provide security from burglary;

(ii) Has substantial doors which may be securely locked during non-working hours by a multiple-position combination or key lock;

(iii) Is equipped with an alarm which, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or State police agency which has a legal duty to respond or a 24-hour control station operated by the registrant or such other protection as the Indiana Board of Pharmacy or the Drug Enforcement Administration may approve; and

(iv) In which all controlled substances are segregated from all other merchandise and kept under constant surveillance during normal business hours.

(c) Multiple storage areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g., returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.

(d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

(e) Compliance with the requirements prescribed in Part 301, Section 301.72 of Title 21 of the Code of Federal Regulations, effective April 1, 1973, shall be deemed in compliance with this section.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.72; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-32 856 IAC 2-3-32 Manufacturing areas; security controls for nonpractitioners

856 IAC 2-3-32 Manufacturing areas; security controls for nonpractitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 32. Physical security controls for nonpractitioners: Manufacturing areas. All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule shall be conducted in accordance with the following:

(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or a local or State Police agency which has a legal duty to respond, or a 24-hour control station operated by registrant.

(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted: Provided: that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.

(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.

(d) Compliance with the requirements prescribed in Part 301, Section 301.73 of Title 21 of the Code of Federal Regulations, effective April 1, 1973, shall be deemed in compliance with this section.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.73; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-33 856 IAC 2-3-33 Additional security controls for nonpractitioners

856 IAC 2-3-33 Additional security controls for nonpractitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 33. Other security controls for nonpractitioners: (a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance the registrant shall make a good faith inquiry either with the Indiana Board of Pharmacy or with the D.E.A. to determine that the person is registered to possess the controlled substance.

(b) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Indiana Board of Pharmacy of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

(c) The registrant shall notify in writing the Indiana Board of Pharmacy of any theft or significant loss of any controlled substances upon discovery of such theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.

(d) The registrant shall not distribute any controlled substance listed in Schedules II through V [856 IAC 2-2-3 – 856 IAC 2-2-6] as a complimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the customer, and (3) only in reasonable quantities. Such request must contain the name, address and state and federal registration number of the customer and the name and quantity of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of Part 3.5 [856 IAC 2-3-24 – 856 IAC 2-3-26] hereof shall be complied with for any distribution of a controlled substance listed in Schedule II [856 IAC 2-2-3] . For purposes of this paragraph, the term "customer" includes a person to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance by the person.

(e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in Section 3.72 [856 IAC 2-3-31] . In addition, the registrant shall employ precautions (e.g., assuring that shipping containers do not indicate that contents are controlled substances) to guard against storage or in-transit losses.

(f) When distributing controlled substances through agents (e.g., detailmen), a registrant is responsible for providing and requiring adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.74; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-34 856 IAC 2-3-34 Storage; security controls for practitioners

856 IAC 2-3-34 Storage; security controls for practitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 34. Physical security controls for practitioners. (a) Controlled substances listed in Schedule I [856 IAC 2-2-2] shall be stored in a securely locked substantially constructed cabinet.

(b) Controlled substances listed in Schedules II, III, IV, and V [856 IAC 2-2-3 – 856 IAC 2-2-6] shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners (as defined) in Chapter I, 1.01 [856 IAC 2-1-1] may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

Controlled substances (institutional practitioners–ward and floor stock) listed in Schedule II [856 IAC 2-2-3] and narcotic drugs in Schedule III [856 IAC 2-2-4] shall be stored in a securely locked substantially constructed cabinet or device. Controlled substances (institutional practitioners ward and floor stock) listed in Schedules III, IV, and V [856 IAC 2-2-4 – 856 IAC 2-2-6] may be dispersed in their ward or floor stock in such a manner as to obstruct theft or diversion of these controlled substances.

(c) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.75; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-3-35 856 IAC 2-3-35 Additional security controls for practitioners

856 IAC 2-3-35 Additional security controls for practitioners

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 35. Other security controls for practitioners. (a) The registrant shall not employ as an agent or employee who has access to controlled substances any person who has had an application for registration denied, or has had his registration revoked, or has been convicted of a violation of State or Federal law relative to the manufacture, distribution, dispensing or possession of controlled substances.

(b) The registrant shall notify the Indiana Board of Pharmacy of the theft or significant loss of any controlled substances upon discovery of such loss or theft.

(Indiana Board of Pharmacy; Reg 28,Ch III,Sec 3.76; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 4

856 IAC 2-4-1 856 IAC 2-4-1 Records and inventories

Rule 4. Records and Inventories of Registrants

856 IAC 2-4-1 Records and inventories

Authority: IC 35-48-3-1

Affected: IC 35-48-3-7

Sec. 1. (a) Every registrant shall keep records and maintain inventories in conformance with the record keeping and inventorying requirements of federal law and regulation.

(b) For purposes of this article, "readily retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some manner visually identifiable apart from other items appearing on the records. Manufacturers, distributors, and research records or electronic data processing printouts shall be made available within five (5) working days after a request by the Indiana board of pharmacy for such records or information on controlled substances transactions.

(c) Each registered pharmacy shall maintain, for a period of two (2) years, its prescriptions of controlled substances by maintaining any of the following:

(1) Three (3) separate files as follows:

(A) A file for schedule II drugs dispensed.

(B) A file for schedules III, IV, and V drugs dispensed.

(C) A file for prescriptions for all other drugs dispensed.

(2) Two (2) separate files as follows:

(A) A file for all noncontrolled drugs dispensed.

(B) Another file for all controlled drugs dispensed in schedules II, III, IV, and V. If this method is used, the prescriptions in the file for schedules III, IV, and V must be stamped with the letter "C" in red ink, not less than one (1) inch high, in the lower right-hand corner.

(3) Two (2) separate files as follows:

(A) A file for schedule II drugs dispensed.

(B) Another file for schedules III, IV, and V drugs, including all other noncontrolled drugs dispensed. If this method is used, the prescriptions in the file of schedules III, IV, and V drugs must be stamped with the letter "C" in red ink, not less than one (1) inch high, in the lower right-hand corner.

However, if a pharmacy employs an automated data processing system or other electronic record keeping system for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" under subdivisions (2) and (3) is waived.

(d) Electronically transmitted prescriptions must be maintained in accordance with applicable federal regulations.

(Indiana Board of Pharmacy; Reg 28, Ch IV, Sec 4.01; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 26, 2000, 8:52 a.m.: 23 IR 2504; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 5

856 IAC 2-5-1 856 IAC 2-5-1 Order form requirements

Rule 5. Order Forms

856 IAC 2-5-1 Order form requirements

Authority: IC 35-48-3-1

Affected: IC 35-48-3-8

Sec. 1. Order Form Requirements Generally. Compliance with the requirements prescribed in section 308 of the Federal Controlled Substances Act (21 U.S.C. 828), and in Part 305 of Title 21 of the Code of Federal Regulations, effective April 1, 1973 shall be deemed compliance with the requirements of IC 1971, 35-24.1-3-7 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch V,Sec 5.01; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 6

856 IAC 2-6-1 856 IAC 2-6-1 Scope of rules governing prescriptions

Rule 6. Issuance, Filling and Filing Prescriptions

856 IAC 2-6-1 Scope of rules governing prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 1. Scope of Part 6. Rules governing the issuance, filling and filing of prescriptions pursuant to IC 1971, 35-24.1-3-8 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, are set forth generally in that section and specifically by the sections of this part [856 IAC 2] .

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.01; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-1.5 856 IAC 2-6-1.5 Signature requirements

856 IAC 2-6-1.5 Signature requirements

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 1.5. All references to "signed" in this rule shall include either:

(1) manually written in pen or indelible pencil; or

(2) electronically signed in accordance with applicable federal regulations.

(Indiana Board of Pharmacy; 856 IAC 2-6-1.5; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-2 856 IAC 2-6-2 Persons entitled to issue prescriptions

856 IAC 2-6-2 Persons entitled to issue prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 2. (a) A prescription for a controlled substance may be issued only by an individual practitioner who is:

(1) authorized to prescribe controlled substances by the state; and

(2) either registered or exempted from registration pursuant to 856 IAC 2-3-5(b) or 856 IAC 2-3-6.

(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an individual practitioner or a practitioner's authorized agent.

(c) Controlled substances prescriptions issued by individual practitioners in adjoining states to Indiana or other states are considered valid prescriptions if the practitioner issuing the prescription has a current and valid Drug Enforcement Administration certificate registration number. It is the pharmacist's responsibility as with all controlled substances prescriptions, to be sure beyond reasonable doubt in his or her professional judgment that the practitioner is issuing the prescription in good faith and has a valid Drug Enforcement Administration certificate of registration.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.02; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 30, 2001, 11:00 a.m.: 25 IR 1343; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-3 856 IAC 2-6-3 Purpose of prescription; prohibitions

856 IAC 2-6-3 Purpose of prescription; prohibitions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 3. Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose in a reasonable quantity by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription, within the meaning and intent of IC 1971, 35-24.1-3-8 [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended, and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.

(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his dependence upon such drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.03; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-4 856 IAC 2-6-4 Issuance of prescriptions; information required

856 IAC 2-6-4 Issuance of prescriptions; information required

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 4. (a) All prescriptions for controlled substances shall be dated as of, and signed, the day when issued and shall bear the full name and address of the patient, and the name, address, and federal controlled substance registration number of the practitioner. A practitioner may sign a prescription either in writing or electronically in accordance with applicable federal regulations. Where an oral order is not permitted, prescriptions shall be:

(1) written with ink, indelible pencil, computer printer, or typewriter and manually signed by the practitioner; or

(2) electronically written, signed, and transmitted in accordance with applicable federal regulations.

(b) Nonelectronically prescribed prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations, or applicable federal regulations.

(c) An intern, resident, or foreign-trained physician exempted from registration under 856 IAC 2-3-5(c) shall include on all prescriptions issued by him or her the federal controlled substance registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in 856 IAC 2-3-5(c) in lieu of the registration number of the practitioner required by this section. Each prescription shall have the name of the intern, resident, or foreign-trained physician stamped or printed on it, as well as the signature of the physician.

(d) An official exempted from registration under 856 IAC 2-3-6 shall include on all prescriptions issued by him or her, his or her branch of service or agency (for example, "U.S. Army" or "Public Health Service") and his or her service identification number in lieu of the federal controlled substance registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his or her Social Security identification number. Each prescription shall have the name of the officer stamped, typed, or hand-printed on it, as well as the signature of the officer.

(e) A prescription issued electronically by a practitioner exempted under subsections (c) and (d) shall conform to applicable federal regulations.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.04; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-5 856 IAC 2-6-5 Persons entitled to fill prescriptions

856 IAC 2-6-5 Persons entitled to fill prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 5. Persons entitled to fill prescriptions. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or by a registered institutional practitioner.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.05; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-6 856 IAC 2-6-6 Dispensing of narcotics for maintenance purposes

856 IAC 2-6-6 Dispensing of narcotics for maintenance purposes

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 6. Dispensing of narcotic drugs for maintenance purposes. The administering or dispensing directly (but not prescribing) of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of treatment of his dependence upon such drugs in the course of conducting a clinical investigation authorized by State or Federal law in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his professional practice or research" in IC 1971, 35-24.1-1-1(u) [Repealed by Acts 1976, P.L.148, SECTION 24; Acts 1977, P.L.26, SECTION 25. See IC 35-48.] as amended.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.06; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-7 856 IAC 2-6-7 Schedule II controlled substances; prescription required; exceptions

856 IAC 2-6-7 Schedule II controlled substances; prescription required; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48

Sec. 7. (a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, only pursuant to a prescription signed by the prescribing individual practitioner, except as provided in subsection (d).

(b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to section 6 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, as defined in subsection (e), a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner provided the following:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner.

(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in section 4 of this rule, except for the signature of the prescribing individual practitioner.

(3) If the prescribing individual practitioner is not known to the pharmacist, he or she must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his or her phone number as listed in the telephone directory and/or other good faith efforts to assure his or her identity.

(4) Within seven (7) days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of section 4 of this rule, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven (7) day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription that had earlier been reduced to writing. The pharmacist shall notify the Indiana board of pharmacy if the prescribing individual fails to deliver a written prescription to him or her, failure of the pharmacist to do so shall void the authority conferred by this subdivision to dispense without a written prescription of a prescribing individual practitioner.

(e) For the purpose of authorizing an oral prescription of a controlled substance listed in schedule II of IC 35-48 as amended, "emergency situation" means those situations in which the prescribing practitioner determines the following:

(1) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.

(2) No appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under schedule II of IC 35-48 as amended.

(3) It is not reasonably possible for the prescribing practitioner to provide a written prescription or electronically transmitted prescription to the person dispensing the substance, prior to the dispensing.

(Indiana Board of Pharmacy; Reg 28, Ch VI,Sec 6.11; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 26, 2000, 8:52 a.m.: 23 IR 2505; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-8 856 IAC 2-6-8 Schedule II controlled substances; refilling prescriptions

856 IAC 2-6-8 Schedule II controlled substances; refilling prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 8. Refilling prescriptions–Schedule II [856 IAC 2-2-3] . The refilling of a prescription for a controlled substance listed in Schedule II [856 IAC 2-2-3] is prohibited.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.12; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-9 856 IAC 2-6-9 Schedule II controlled substances; partial filling of prescriptions

856 IAC 2-6-9 Schedule II controlled substances; partial filling of prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-2-6; IC 35-48-3-9

Sec. 9. (a) The partial filling of a prescription for a controlled substance listed in schedule II under IC 35-48-2-6, as amended, is permissible if the pharmacist is unable to supply the full quantity called for in a prescription written either manually or electronically in accordance with applicable federal regulations, or emergency oral prescription and makes a notation of the quantity supplied on the face of the written prescription, on the written record of the emergency oral prescription or electronically recorded if electronically transmitted. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling. However, if the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

(b) A prescription prescribed, either in writing or electronically in accordance with applicable federal regulations, for a schedule II controlled substance for patients in long-term care facilities may be filled in partial quantities to include individual dosage units. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the:

(1) date of the partial filling;

(2) quantity dispensed;

(3) remaining quantity authorized to be dispensed; and

(4) identification of the dispensing pharmacist.

The total quantity of a schedule II controlled substance dispensed in all partial fillings must not exceed the total quantity prescribed. A schedule II prescription, for a patient in a long-term care facility, shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by the discontinuance of medication.

(c) A prescription for a schedule II controlled substance prescribed, either in writing or electronically in accordance with applicable federal regulations, for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. The pharmacist has a responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription the patient is "terminally ill". A prescription that is partially filled and does not contain the notation "terminally ill" shall be deemed to have been filled in violation of this section. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the:

(1) date of the partial filling;

(2) quantity dispensed;

(3) remaining quantity authorized to be dispensed; and

(4) identification of the dispensing pharmacist.

Prior to any subsequent partial filling, the pharmacist is to determine that the additional partial filling is necessary. The total quantity of a schedule II controlled substance dispensed in all partial fillings must not exceed the total quantity prescribed. A schedule II prescription for a patient with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by the discontinuance of medication.

(Indiana Board of Pharmacy; Reg 28, Ch VI, Sec 6.13; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 8, 1986, 9:55 a.m.: 9 IR 2205; filed Mar 31, 1992, 5:00 p.m.: 15 IR 1391; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-10 856 IAC 2-6-10 Schedule II controlled substances; label information; exceptions

856 IAC 2-6-10 Schedule II controlled substances; label information; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 10. (a) The pharmacist filling a written prescription, an electronically transmitted prescription, or an emergency oral prescription for a controlled substance listed in 856 IAC 2-2-3, Schedule II, shall affix to the package a label showing the following:

(1) The date of filling.

(2) The pharmacy name and address.

(3) The serial number of the prescription.

(4) The name of the patient.

(5) The name of the prescribing practitioner.

(6) Directions for use.

(7) The cautionary statement, "Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed".

(8) Any others if any, contained in the prescription or required by law.

(b) The requirements of subsection (a) do not apply when a controlled substance listed in 856 IAC 2-2-3, Schedule II, is prescribed for administration to an ultimate user who is institutionalized, provided the following:

(1) Not more than a seven (7) day supply of the controlled substance listed in 856 IAC 2-2-3, Schedule II, is dispensed at one (1) time.

(2) The controlled substance listed in 856 IAC 2-2-3, Schedule II, is not in the possession of the ultimate user prior to the administration.

(3) The institution maintains appropriate safeguards and records regarding the proper:

(A) administration;

(B) control;

(C) dispensing; and

(D) storage;

of the controlled substance listed in 856 IAC 2-2-3, Schedule II.

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.14; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-11 856 IAC 2-6-11 Schedule II controlled substances; retention of prescriptions (Repealed)

856 IAC 2-6-11 Schedule II controlled substances; retention of prescriptions (Repealed)

(Repealed by Indiana Board of Pharmacy; filed Nov 30, 2001, 11:00 a.m.: 25 IR 1344)

856 IAC 2-6-12 856 IAC 2-6-12 Schedules III and IV controlled substances

856 IAC 2-6-12 Schedules III and IV controlled substances

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 12. (a) A pharmacist may dispense a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5, which is a prescription drug as determined under the federal Food, Drug, and Cosmetic Act, only pursuant to either a prescription signed by a prescribing individual practitioner or an oral prescription made by a prescribing individual practitioner or a practitioner's authorized agent and promptly reduced to writing by the pharmacist containing all information required in section 4 of this rule, except for the signature of the prescribing individual practitioner.

(b) An individual practitioner may administer or dispense a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5 in the course of his or her professional practice without a prescription, subject to section 6 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule III or IV under 856 IAC 2-2-4 or 856 IAC 2-2-5 pursuant to a prescription signed by a prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in section 4 of this rule, except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to section 6 of this rule.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.21; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 30, 2001, 11:00 a.m.: 25 IR 1343; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-13 856 IAC 2-6-13 Schedules III, IV, and V controlled substances; refilling prescriptions; retrievable information

856 IAC 2-6-13 Schedules III, IV, and V controlled substances; refilling prescriptions; retrievable information

Authority: IC 35-48-3-1

Affected: IC 35-48-2; IC 35-48-3-9

Sec. 13. (a) No prescription for a controlled substance listed in schedule III (IC 35-48-2-8), schedule IV (IC 35-48-2-10), or schedule V (IC 35-48-2-12) shall be filled or refilled more than six (6) months after the date on which such prescription was issued, and no such prescription shall be authorized to be refilled more than five (5) times.

(b) Each refill of a prescription shall be recorded by one (1) of the following methods:

(1) On the back of the original prescription, an electronically transmitted record in accordance with applicable federal regulations, or a uniformly maintained, readily retrievable record.

(2) In the storage memory of an electronic data processing system if such board approved system is used in the pharmacy.

(c) The following prescription information shall be retrievable by using or entering the serial number of the prescription:

(1) The name (and strength, if applicable) and dosage form of the controlled substance.

(2) The date on which the prescription was written, electronically transmitted, or orally transmitted and reduced to writing by the pharmacist.

(3) The date of original filling and the date or dates of all refills.

(4) A notation or notations for the original filling and each and every subsequent refilling sufficient to identify the dispensing pharmacist.

(5) The total number of refills originally authorized and remaining for each individual prescription.

If the pharmacist does nothing more than date and initial the prescription to indicate a refill has been dispensed, the pharmacist shall be deemed to have dispensed a refill for the full face amount (that is the originally prescribed amount) of the prescription.

(d) Additional refills for prescriptions for controlled substances listed in schedule III (IC 35-48-2-8), schedule IV (IC 35-48-2-10), or schedule V (IC 35-48-2-12) may be added to the original prescription pursuant to an authorization transmitted to the pharmacist by the original prescribing practitioner providing the following conditions are met:

(1) The total quantity authorized does not exceed the original face amount of the prescription and five (5) total refills, and none of the refills is for more dose units or a larger quantity than the original face amount of the prescription.

(2) No dispensing takes place pursuant to the original prescription more than six (6) months after the date of the original issue of the prescription.

(3) The pharmacist receiving the authorization records that authorization on the reverse of the original prescription, or in a readily retrievable record, and the following information:

(A) The date of the authorization.

(B) The number of the dose units or quantity authorized.

(C) The number of additional refills authorized.

(D) The initials of the pharmacist receiving the authorization.

(e) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five (5) refill, six (6) month limitation.

(Indiana Board of Pharmacy; Reg 28, Ch VI, Sec 6.22; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 20, 1988, 9:30 a.m.: 11 IR 3564; filed Jul 5, 1995, 10:00 a.m.: 18 IR 2783; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-14 856 IAC 2-6-14 Schedules III, IV and V controlled substances; partial filling of prescriptions

856 IAC 2-6-14 Schedules III, IV and V controlled substances; partial filling of prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 14. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V in the Controlled Substance Act, IC 35-48 as amended is permissible, provided that:

(a) each partial filling is recorded in the same manner as a refilling,

(b) the total quantity dispensed pursuant to an individual prescription including the original and all subsequent partial refills does not exceed the total quantity prescribed, and

(c) no dispensing occurs more than six (6) months after the date on which the prescription was issued.

(Indiana Board of Pharmacy; Reg 28, Ch VI, Sec 6.23; filed Jul 9, 1974, 9:29 am: Unpublished; filed May 20, 1988, 9:30 am: 11 IR 3565; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-15 856 IAC 2-6-15 Schedules III and IV controlled substances; label information; exceptions

856 IAC 2-6-15 Schedules III and IV controlled substances; label information; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 15. Labeling of substances. (a) The pharmacist filling a prescription for a controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statement, "Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed", and other if any, contained in such prescription as required by law.

(b) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is prescribed for administration to an ultimate user who is institutionalized: Provided, That:

(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is dispensed at one time;

(2) The controlled substance listed in schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] is not in the possession of the ultimate user prior to administration;

(3) The institution maintains appropriate safeguards and records, the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III or IV [856 IAC 2-2-4 or 856 IAC 2-2-5] ; and

(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.24; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-16 856 IAC 2-6-16 Schedules III and IV controlled substances; retention of prescriptions

856 IAC 2-6-16 Schedules III and IV controlled substances; retention of prescriptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 16. Filing prescriptions. All prescriptions for controlled substances listed in Schedules III and IV [856 IAC 2-2-4 or 856 IAC 2-2-5] shall be kept in accordance with section 4.01 [856 IAC 2-4-1] of these regulations.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.25; filed Jul 9, 1974, 9:29 am: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-17 856 IAC 2-6-17 Schedule V controlled substances; prescription requirements; refilling; exceptions

856 IAC 2-6-17 Schedule V controlled substances; prescription requirements; refilling; exceptions

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 17. (a) A pharmacist may dispense a controlled substance listed in 856 IAC 2-2-6, Schedule V, pursuant to a prescription as required for controlled substances listed in 856 IAC 2-2-4 and 856 IAC 2-2-5, Schedules III and IV, in section 12 of this rule. A prescription for a controlled substance listed in 856 IAC 2-2-6, Schedule V, may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If no such authorization is given, the prescription may not be refilled. A pharmacist dispensing such substance pursuant to a prescription shall label the substance in accordance with section 15 of this rule and file the prescription in accordance with [section] 16 of this rule.

(b) An individual practitioner may administer or dispense a controlled substance listed in 856 IAC 2-2-6, Schedule V, in the course of his or her professional practice without a prescription, subject to section 15 of this rule.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in 856 IAC 2-2-6, Schedule V, only pursuant to:

(1) a prescription signed by the prescribing individual practitioner;

(2) an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in section 4 of this rule except for the signature of the prescribing individual practitioner); or

(3) an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to section 15 of this rule.

(Indiana Board of Pharmacy; Reg 28,Ch VI,Sec 6.31; filed Jul 9, 1974, 9:29 a.m.: Unpublished; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-6-18 856 IAC 2-6-18 Dispensing without prescription; delivery of devices

856 IAC 2-6-18 Dispensing without prescription; delivery of devices

Authority: IC 35-48-3-1

Affected: IC 35-48-3-9

Sec. 18. (a) A controlled substance listed in schedule V in the Controlled Substance Act, IC 35-48, that does not require a prescription under federal, state, or local law or a device known as a hypodermic syringe or needle, or both, for human use may be dispensed only by a pharmacist or a pharmacist intern under the direct supervision of a pharmacist without a prescription to a purchaser at retail, provided the following:

(1) Not more than:

(A) two hundred forty (240) cubic centimeters (cc) (eight (8) ounces) or forty-eight (48) dosage units of any substance containing opium may be dispensed at retail to the same purchaser in any given forty-eight (48) hour period; or

(B) one hundred twenty (120) cc (four (4) ounces) or twenty-four (24) dosage units of any other substance nor more than forty-eight (48) dosage units may be dispensed at retail to the same purchaser in any given forty-eight (48) hour period.

(2) The purchaser is at least eighteen (18) years of age. However, if the item being purchased is a device known as a hypodermic syringe or needle, or both, for human use, the age restriction shall not apply.

(3) The pharmacist or pharmacist intern requires every purchaser of a controlled substance or device as described in subsection (a) not known to the pharmacist to furnish suitable identification (including proof of age where appropriate).

(4) Separate bound record books for dispensing of:

(A) controlled substances; and

(B) devices under this section;

are maintained by the pharmacist. These books shall contain the name and address of the purchaser, the name and quantity of controlled substance or devices purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance or devices to the purchaser and shall be maintained in accordance with the record keeping requirements of 856 IAC 2-4-1.

(b) Delivery of devices, as described above, to inpatients of institutions is exempt from this section.

(c) The delivery of a device known as a hypodermic syringe-needle other than by a pharmacist or pharmacist intern in a licensed pharmacy or a licensed practitioner in his or her lawful place of practice is prohibited.

(Indiana Board of Pharmacy; Reg 28, Ch VI, Sec 6.32; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 20, 1988, 9:30 a.m.: 11 IR 3565; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

Rule 7

856 IAC 2-7-1 856 IAC 2-7-1 Application

Rule 7. Limited Permits

856 IAC 2-7-1 Application

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 1. (a) A humane society, animal control agency, or governmental entity that intends to operate an animal shelter or other animal impounding facility for the purpose of buying, possessing, and using drugs authorized by IC 35-48-3-2 shall apply for a limited permit in the form and manner required by the board.

(b) The applicant shall provide the following:

(1) Name and address of the facility.

(2) Type of facility.

(3) Documentation describing the ownership of the facility.

(4) Fees set by the board in this rule.

(5) Information about the substances that the facility intends to administer.

(6) Written policies relating to storage, security, and procedures for access, handling, and administration of drugs.

(7) Proof that the employees of the applicant who will handle a controlled substance are sufficiently trained to use and administer the controlled substance.

(8) Proof that a licensed Indiana veterinarian holding a valid Indiana controlled substances registration and federal DEA registration has been retained to provide technical advice to the facility.

(c) No humane society, animal control agency, or governmental entity that intends to operate an animal shelter or other animal impounding facility for the purpose of buying, possessing, and using drugs authorized by IC 35-48-3-2 shall engage in any activity for which a permit is required until the permit is granted by the board.

(Indiana Board of Pharmacy; 856 IAC 2-7-1; filed Aug 21, 2003, 4:45 p.m.: 27 IR 181; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-2 856 IAC 2-7-2 Permit fees

856 IAC 2-7-2 Permit fees

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 2. The board shall charge and collect the following fees:

(1) Application for a limited permit, fifty dollars ($50).

(2) Annual renewal of limited permit, twenty-five dollars ($25).

(Indiana Board of Pharmacy; 856 IAC 2-7-2; filed Aug 21, 2003, 4:45 p.m.: 27 IR 182; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-3 856 IAC 2-7-3 Renewal of permit

856 IAC 2-7-3 Renewal of permit

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 3. The renewal of the limited permits issued under this section shall be on the same schedule as other humane societies, animal control agencies, or governmental entities that hold controlled substance registrations issued by the board.

(Indiana Board of Pharmacy; 856 IAC 2-7-3; filed Aug 21, 2003, 4:45 p.m.: 27 IR 182; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-4 856 IAC 2-7-4 Storage, handling, and use of controlled substances

856 IAC 2-7-4 Storage, handling, and use of controlled substances

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 4. (a) Limited permit holders and their agents, representatives, and employees must comply with the requirements of this rule for the storage and handling of controlled substances.

(b) All facilities at which controlled substances are stored, handled, or used shall:

(1) be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas large enough to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) have a quarantine area for storage of controlled substances that are:

(A) outdated, damaged, deteriorated, misbranded, or adulterated; or

(B) in immediate or sealed secondary containers that have been opened;

(4) be maintained in a clean and orderly condition; and

(5) be free from infestation by insects, rodents, birds, or vermin of any kind.

(c) All facilities used for storage of controlled substances by registrants under this section shall comply with the security requirements as provided by 856 IAC 2-3-31.

(d) All controlled substances shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such controlled substances or with requirements in the current edition of an official compendium of drug information.

(e) If no storage requirements are established for a controlled substance, the controlled substance may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(f) Controlled substances that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other controlled substances until they are destroyed by a designated agent of the board or returned to their supplier.

(g) Any controlled substance whose immediate or sealed outer or sealed secondary containers have been opened or used shall be:

(1) identified as such; and

(2) quarantined and physically separated from other controlled substances until they are either destroyed by a designated agent of the board or returned to the supplier.

(h) Limited permit holders shall establish and maintain inventories and records of all controlled substances stored or used at the facility.

(i) Inventories and records shall be made available for inspection and photocopying by any authorized official of any governmental agency charged with enforcement of this rule for a period of two (2) years following disposition of the controlled substances.

(j) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of any governmental agency charged with enforcement of this rule.

(Indiana Board of Pharmacy; 856 IAC 2-7-4; filed Aug 21, 2003, 4:45 p.m.: 27 IR 182; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-5 856 IAC 2-7-5 Training of staff

856 IAC 2-7-5 Training of staff

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 5. (a) Only employees of the limited permit holder are eligible for training to store, handle, and use controlled substances. Volunteers are prohibited from storing, handling, or using controlled substances.

(b) The following training is required:

(1) Completion of a comprehensive training program approved by the controlled substance advisory committee.

(2) Any additional training as required by the supervising veterinarian or site administrator.

(c) A veterinarian licensed to practice in Indiana, holding a valid Indiana controlled substances registration and federal DEA registration, must verify in writing that the employee has been trained adequately to store, handle, or use controlled substances. The written verification must be maintained at the facility in a reasonably retrievable manner.

(d) The limited permit holder or site administrator shall maintain documentary proof of training in a reasonably retrievable manner at the facility for review by an authorized official of any governmental agency charged with enforcement of this rule.

(Indiana Board of Pharmacy; 856 IAC 2-7-5; filed Aug 21, 2003, 4:45 p.m.: 27 IR 183; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-6 856 IAC 2-7-6 Protocol for administration of controlled substances

856 IAC 2-7-6 Protocol for administration of controlled substances

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 6. In the event the consulting veterinarian is not physically present during the administration of controlled substances by employees of the limited permit holder, the veterinarian shall be available for consultation by telephonic or other electronic device.

(Indiana Board of Pharmacy; 856 IAC 2-7-6; filed Aug 21, 2003, 4:45 p.m.: 27 IR 183; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)

856 IAC 2-7-7 856 IAC 2-7-7 Limitations on permit

856 IAC 2-7-7 Limitations on permit

Authority: IC 35-48-3-2

Affected: IC 35-48-3-2

Sec. 7. (a) Except as provided in subsection (b), only controlled substances for which the humane society, animal control agency, or governmental entity has received a permit may be stored, handled, and used at the facility.

(b) A licensed veterinarian who stores, handles, or uses controlled substances at the humane society, animal control agency, or governmental entity other than those authorized under the facility's limited permit, must apply for and obtain a controlled substance registration for the facility in the veterinarian's name.

(c) The veterinarian who holds the registration noted in subsection (b) is responsible for the proper storage, handling, and use of the controlled substances authorized for use under the veterinarian's controlled substance registration.

(Indiana Board of Pharmacy; 856 IAC 2-7-7; filed Aug 21, 2003, 4:45 p.m.: 27 IR 183; readopted filed Dec 1, 2009, 9:13 a.m.: 20091223-IR-856090782RFA; readopted filed Nov 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA; readopted filed Nov 18, 2019, 11:41 a.m.: 20191218-IR-856190076RFA; readopted filed Feb 15, 2024, 1:16 p.m.: 20240313-IR-856230795RFA)