Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Guidance for Industry
Reporting Drug Sample
Information Under Section
6004 of the Affordable Care Act
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 90 days of
publication in the Federal Register of the notice announcing the availability of the draft guidance.
Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket number listed in the notice
of availability that publishes in the Federal Register.
For questions regarding this draft document contact FDA, Center for Drug Evaluation and Research,
Office of Business Informatics at CDER-OBI-ACA6004@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2014
Electronic Submissions
Revised Draft

Guidance for Industry
Reporting Drug Sample
Information Under Section
6004 of the Affordable Care
Act
Additional copies are available from:
Division of Drug Information
Office of Communications
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Avenue
Hillandale Building, 4 th Floor, 4147
Silver Spring, MD 20993
(Tel) 301-796-3400 or 855-543-3784; (Fax) 301-431-6353
druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
or
Office of Communications, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., WO71, Rm. 3128
(Tel) 800-835-4709 or 240-402-7800
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
July 2014
Electronic Submissions
Revised Draft

TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	DISCUSSION .................................................................................................................... 3
A. 	What Definitions Apply? ............................................................................................................... 3
B. 	Who Submits Drug Sample Information? ................................................................................... 4
C. 	How Should Drug Sample Information Be Reported? ............................................................... 5
D. 	What Drug Sample Information Is Included in a Submission?................................................. 5

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Guidance for Industry1
Reporting Drug Sample Information
Under Section 6004 of the Affordable Care Act
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current
thinking on this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of
the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA
staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call
the appropriate number listed on the title page of this guidance.
I. 	INTRODUCTION
This guidance document is intended to assist persons reporting drug sample distribution
information2 to FDA under section 6004 of the Patient Protection and Affordable Care Act
(ACA). The guidance explains, among other things:
• 	The statutory requirement to submit drug sample distribution information
• 	Definitions relevant to drug sample distribution information submissions
• 	Who submits drug sample information
• 	What information is to be submitted
• 	How to submit the information
• 	When to submit the information
• 	FDA’s compliance policies related to drug distribution information submissions
This draft revises the April 3, 2012, draft guidance for industry entitled Compliance Policy on
Reporting Drug Sample Distribution Information. This draft revision updates the information in
the April 2012 guidance to better assist persons using the Gateway to submit drug sample
information under ACA section 6004 and to advise industry of an updated compliance policy.
The revised draft guidance replaces the April 3, 2012, draft guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
1 This guidance has been prepared by the Center for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research.
2 For purposes of this guidance the term drug sample means a unit of a drug, subject to section 503(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), which is not intended to be sold and is intended to promote the sale of
the drug.

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cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. 	BACKGROUND
On March 23, 2010, the ACA was signed into law. Among its many provisions, section 6004
amended the Social Security Act by adding section 1128H (42 U.S.C. 1320a-7i). This new
section requires the submission of certain drug sample information to FDA not later than April 1
of each year, beginning April 1, 2012.
In particular, section 6004 requires manufacturers and authorized distributors of record (ADRs)
of “applicable drugs” to annually report the identity and quantity of drug samples that were
requested and distributed under section 503(d)(2) and (d)(3) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).3 This information must be aggregated by: (1) the name, address,
professional designation, and signature of the practitioner making the drug sample request or of
any individual who makes or signs for the request on behalf of the practitioner; and (2) any other
category of information determined appropriate by the Secretary of the U.S. Department of
Health and Human Services (Secretary).4 The Secretary has delegated to FDA the authority to
issue guidance identifying the information to be submitted under section 6004, and to oversee
and arrange for the collection of such information.
Section 6004 is not part of the Prescription Drug Marketing Act (PDMA) but must be read
together with that Act. Two of the terms used in section 6004 are defined by reference to the
PDMA. In addition, the PDMA and its implementing regulations5 require the collection and
maintenance of information that must be submitted under section 6004. For example, 21 CFR
203.38(b) requires that a manufacturer or ADR maintain records of drug sample distribution for
all samples distributed under section 503(d)(2) or 503(d)(3) of the FD&C Act that are sufficient
to permit tracking of sample units to the point of the licensed practitioner. Under section 6004,
manufacturers and ADRs must now submit much of the same information, aggregated as
specified, to FDA.
On April 3, 2012, FDA issued a draft guidance, entitled Guidance for Industry -- Compliance
Policy on Reporting Drug Sample Distribution Information Under the Affordable Care Act,
concerning section 6004. In that guidance, FDA explained the availability of the Electronic
Submissions Gateway (the Gateway) for submission of drug sample information required by
section 6004, FDA’s temporary compliance policy with regard to those submissions, and FDA’s
intent to issue subsequent guidance. FDA is now issuing this guidance to provide information to
assist persons submitting drug sample information under section 6004, and to advise industry of
a new compliance policy. For technical instruction on using the Gateway system to report drug
3 See 21 U.S.C. 353(d)(2) and (d)(3).
4 See 42 U.S.C. 1320a-7i(a).
5 See 21 CFR part 203 subpart D.

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sample distribution information, please refer to Affordable Care Act (ACA) 6004 – ACA Industry
Submission Specifications User Guide.6
III. 	DISCUSSION
A. 	What Definitions Apply?
As noted above, the reporting requirement in section 6004 of the ACA (adding 1128H to the
Social Security Act) applies to distributions of certain drugs under 503(d)(2) and (d)(3) of the
FD&C Act. FDA intends to use the following definitions in implementing the requirements of
section 6004:
1. 	Applicable drug: An applicable drug is a drug that is subject to section 503(b) of the
FD&C Act (21 U.S.C. 353(b)) and for which payment is available under title XVIII of
the Social Security Act (SSA) or a State plan under title XIX or XXI of the SSA (or a
waiver of such a plan).7
2. 	Authorized distributor of record (ADR): “[T]hose distributors with whom a
manufacturer has established an ongoing relationship to distribute such manufacturer’s
products.” 8 An entity that is an ADR under section 503(d) of the FD&C Act is also an
ADR under section 1128H of the SSA.9,10
3. 	Ongoing relationship: An association that exists when a manufacturer and a distributor
enter into a written agreement under which the distributor is authorized to distribute the
manufacturer’s products for a period of time or for a number of shipments. If the
distributor is not authorized to distribute a manufacturer’s entire product line, the
agreement must identify the specific drug products that the distributor is authorized to
distribute.11 FDA uses this definition in determining whether an entity is an ADR
making distributions under 503(d)(2) or (3).
4. 	Distribute: To sell, offer to sell, deliver, or offer to deliver a drug to a recipient, except
that the term does not include (1) delivering or offering to deliver a drug by a common
6 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM297610.pdf.
7 SSA section 1128H(b)(1) (42 U.S.C. 1320a-7i(b)(1).
8 Effective January 1, 2015, section 583(b) and (c) of the Drug Supply Chain Security Act, (part of the Drug Quality
and Security Act (DQSA), signed into law on November 27, 2013) the definition of ADR was moved to section
503(d)(4) of the FD&C Act.
9 SSA section 1128H(b)(2) (42 U.S.C. 1320a-7i(b)(2)), incorporating the meaning of this term codified in section
503(e)(3) of the FD&C Act (21 U.S.C. 353(e)(3).
10 For more information about the definition of ADR and ongoing relationship for purposes of section 503(d) of the
FD&C Act, see
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134399.pdf.
11 See 21 CFR 203.3(u).

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carrier in the usual course of business as a common carrier; or (2) providing a drug
sample to a patient by a practitioner licensed to provide the drug, or by a health care
professional acting at the direction and under the supervision of such a practitioner; or by
the pharmacy of a hospital or another health care entity acting at the direction of a
licensed practitioner that received a sample in accordance with the FD&C Act and related
regulations.12
5. 	Drug sample: A unit of a prescription drug that is not intended to be sold and is intended
to promote the sale of the drug.13
6. 	Manufacturer: “[T]he person who performs all of the following operations that are
required to produce the product: (1) Mixing, (2) granulating, (3) milling, (4) molding, (5)
lyophilizing, (6) tableting, (7) encapsulating, (8) coating, (9) sterilizing, and (10) filling
sterile, aerosol, or gaseous drugs into dispensing containers.”14
B. 	Who Submits Drug Sample Information?
The requirement to submit drug sample information under section 6004 of the ACA applies to
each manufacturer and ADR of an applicable drug that makes distributions under subsection
(d)(2) or (d)(3) of section 503 of the FD&C Act. In general, this means that both manufacturers
and ADRs of applicable drugs should submit drug sample information to FDA.
We recognize that there may be instances when a manufacturer and ADR both have records
regarding the same drug sample request or distribution. In such cases, only one of the two
entities should submit the required drug sample information to FDA. For example, when a
manufacturer provides an applicable drug sample to an ADR, which in turn distributes the drug
sample to a physician, the distribution to the physician should be reported only once ― by either
the manufacturer or the ADR. Given that manufacturers and their ADRs are required to have
written documentation of their relationship (21 CFR 203.3(b),(u)), we recommend that ADR
agreements specify who is responsible for reporting the required drug sample information to
FDA.
FDA also recognizes that there may be instances when requests for samples are transmitted to a
manufacturer through an ADR, or when multiple ADRs are used to fulfill a single sample request
received by a manufacturer. FDA expects manufacturers to ensure that the submissions for such
drug sample requests and distributions are complete and non-duplicative. FDA believes that
manufacturers are best positioned to determine who will do the reporting for their drug sample
requests and distributions. FDA will not object if a third party is contracted by the manufacturer
to provide the report to FDA, provided the contractor clearly identifies the manufacturer for
12 See 21 CFR 203.3(h).
13 See 21 CFR 203.3(i).
14 See 21 CFR 201.1(b). See also SSA section 1128H(b)(3) (42 U.S.C. 1320a-7i(b)(3)), incorporating the meaning
given to the term “manufacturer” for purposes of section 503(d) FD&C Act.

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whom it is reporting. In each such case, the person or firm submitting a report should identify
the manufacturer for whom the report is being made.
C. 	How Should Drug Sample Information Be Reported?
FDA strongly encourages use of the Electronic Submissions Gateway (Gateway) for the
submission of drug sample data required by section 6004 of the ACA. The Gateway became
available for drug sample reporting under section 6004 in March 2012, and FDA intends to
continue the use of the Gateway for this purpose. For information about the Gateway, which is
also used for a number of other submissions to FDA, see
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. This website
provides useful information, including how to setup a Gateway account.
The Gateway accepts submissions made in XML format. For technical specifications, contact
information, and other helpful information for creating section 6004 submissions, see
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm.
Among other things, this page contains a link for downloading the XML schema for a
submission and an XML example, as well as a user guide and a document that provides answers
to frequently asked questions.
For questions about the Gateway, please contact esgreg@gnsi.com. For all other questions about
making a section 6004 submission, please contact cder-obi-aca6004@fda.hhs.gov.
D. 	What Drug Sample Information Should Be Included in a Submission?
Under section 6004 of the ACA, manufacturers and ADRs of applicable drugs must submit the
identity and quantity of drug samples requested and the identity and quantity of drug samples
distributed, aggregated by the name, address, professional designation, signature of the
practitioner making the request, and signature of the practitioner or the practitioner’s designee
receiving the distributed drug samples. As noted above, we request that the required information
be submitted only once; the manufacturer and its ADRs should determine who is best suited to
make these submissions.
We read section 6004 as requiring that manufacturers and ADRs provide information about the
identity and quantity of all drug sample requests and distributions made under sections 503(d)(2)
and 503(d)(3) of the FD&C Act. Below, we discuss our interpretation of certain terms in section
6004, the aggregation of drug sample reports, and the period to be covered by each report.
1. 	Background – Requirements of the PDMA and Section 6004 of the ACA
In general, the information reported to FDA under section 6004 should be based on
information that a manufacturers or ADR collected under the PDMA. As set forth in the
PDMA regulations, drug samples may be requested only by practitioners licensed in their
state to prescribe the requested drugs.15 A written request containing the practitioner’s
15 See 21 CFR 203.30 and 203.31.

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name, address, professional designation, identity of the drug sample requested, quantity
of drug sample requested, and signature of the practitioner making the request must be
received by the manufacturer or ADR for each drug sample distribution.16 Drug samples
may be delivered to a practitioner’s office or practice, an affiliated hospital pharmacy, or
another place where someone other than the requesting practitioner may sign for receipt
of the drug samples. If someone other than the requesting practitioner receives a sample,
that person must be designated by the practitioner as an authorized recipient of the drug
sample and sign for the sample on the practitioner’s behalf. These signatures should be
collected to enable compliance with the PDMA and should provide the information
needed to compile the reports required by section 6004.
2. 	Identity of drug samples requested or distributed
When reporting drug sample information to FDA, the information provided should be sufficient
for the Agency to identify each unique drug product sample that was requested or distributed.
The drug sample information submitted via the Gateway must include the following data
elements: trade name, strength, dosage of the samples, and sample package size (which includes
the units/#per unit dosage).
3. 	Aggregation of drug sample information
FDA interprets the aggregation requirements in section 6004 to require that the quantity of drug
samples requested and distributed be reported, with respect to each drug product,
• 	for each person who makes a drug sample request, and
• 	for each person who signs at the time of a drug sample distribution.
Thus, if a practitioner requested 300 samples of drug X and signed for 300 samples of drug X,
both quantities would be reported for that practitioner. Alternatively, if a practitioner requested
300 samples of drug Y and designated a pharmacist to sign for 300 samples of drug Y, these
quantities would be reported separately for the practitioner and pharmacist.
In addition, we interpret section 6004 to require that an address be provided for each requester
and designee. Section 6004 requires aggregation by the address of the practitioner making the
request and the address of the individual who signs for delivery of the requested samples (which
may be the same as or different from the practitioner’s address). The elements permitted in the
Gateway for a standard address consist of a street number, street name, suite or room number,
the U.S. city name, a two-letter abbreviation of the U.S. state, and a zip code in the format of
12345-6789.
We also interpret section 6004’s requirement that drug sample information be aggregated by
signature to mean that the information be aggregated by person for each person who requests
and, at the time of delivery, signs for a drug sample under section 503(d)(2) or (d)(3).
Accordingly, a section 6004 submission should aggregate drug sample information by (1) the
16 See 21 CFR 203.30(b).

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name of, and professional designation (title) for, each practitioner who made a request, and (2)
each designated person, if other than the requesting practitioner, who received the drug samples.
FDA does not believe that the actual, individual signatures must be submitted to comply
with the provision in section 6004 that requires “aggregation” of drug sample information
by signature. It would be impractical for manufacturers or ADRs to submit, and for FDA
to receive, such voluminous records. Thus, the Gateway includes checkboxes to indicate
whether the signature of the medical practitioner who actually signed a request for
samples and the person who signed for the delivered samples (either the requesting
practitioner or the practitioner’s designee) are on file with the manufacturer or ADR. The
example below illustrates how the Gateway should be used to report signature
information for drug sample requests and distributions.
Example: Dr. Jones requests 500 samples of drug product X. The manufacturer
distributes 250 samples to Dr. Jones at her clinic, and at Dr. Jones’ request, the
remaining 250 are delivered to Dr. Jones’ designee, Mr. Smith, at a different
address. The manufacturer determines that it has appropriate signatures on file
for the drug sample request and for the samples distributed to Dr. Jones and Mr.
Smith. The manufacturer should use the Gateway to report that Dr. Jones
requested 500 samples of drug product X, that Dr. Jones received 250 of those
samples, and that Mr. Smith received the remaining 250 samples. The addresses
for both Dr. Jones and Mr. Smith should be provided, and the manufacturer
should affirm that it maintains the signature information for Dr. Jones and Mr.
Smith by checking the appropriate box in the Gateway submission window.
The ACA 6004 XML schema and a sample demonstrating aggregation reporting may be
found in a link (“ACA 6004 XML Schema and Sample”) available from FDA’s
Affordable Care Act (ACA 6004) webpage at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm.
4. 	Period covered by each report
Section 6004 requires reports to be submitted not later than April 1 of each year with respect to
the previous year. FDA interprets this requirement to mean that a report is required each year,
submitted no later than April 1, for the distributions and requests that occurred during the
previous calendar year. For example, manufacturers and ADRs must report, not later than April
1, 2014, on distributions and requests that occurred between January 1, 2013, and December 31,
2013.
Requests and distributions are to be reported for the year in which they occurred. FDA
recognizes that, as a consequence, the number of requests and the number of deliveries may not
be the same for a given reporting period. For example, if a practitioner requests 100 samples of
drug X and the manufacturer fulfills only half of the request before the year ends, a report for
that year would show 100 samples requested and 50 distributed. If the manufacturer filled the
rest of the request in the following year, the manufacturer would report the distribution of 50

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samples to that physician, along with any other distributions made to that physician (or the
physician’s designee) during the calendar year in which the distributions were made.
E. 	FDA’s Compliance Policies
Section 6004 of the ACA required the submission of information concerning drug sample
distribution to FDA beginning April 1, 2012. On April 3, 2012, FDA issued a draft guidance
explaining that, although the Gateway had become available for submissions, FDA intended to
use enforcement discretion until at least October 1, 2012, for manufacturers and ADRs who had
not submitted information under those reporting provisions. FDA further explained that it
intended to notify relevant manufacturers and ADRs before lifting this exercise of discretion.
FDA based this decision in large part on the newness of the requirement and the unavailability of
the Gateway for submissions before late March 2012.
Before October 1, 2012, FDA announced on its website17 that it was not revising its compliance
policy with regard to section 6004 submissions, and that FDA expected to issue further guidance
regarding its compliance policy, including the timing of FDA enforcement decisions, in 2013.
This guidance reflects FDA’s position with regard to its enforcement of the requirements in
section 6004. FDA expects manufacturers and ADRs to comply with section 6004 according to
the policies set forth in this guidance, beginning with the submission of data for 2014 due no
later than April 1, 2015.
17 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm292040.htm