[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Pages 6443-6449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket No. FDA-2020-N-1819]
RIN 0910-AH56


Certain Requirements Regarding Prescription Drug Marketing

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to amend certain prescription drug marketing regulations to 
reflect changes to affected provisions of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) resulting from enactment of the Drug Supply 
Chain Security Act (DSCSA), Title II of the Drug Quality and Security 
Act (DQSA). This action, if finalized, will remove or revise outdated 
and conflicting regulatory requirements to align with changes to 
affected provisions of the FD&C Act following enactment of the DSCSA.

DATES: Submit either electronic or written comments on the proposed 
rule by April 5, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 5, 2022. Electronic 
comments must be submitted on or before that date. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2020-N-1819 for ``Certain Requirements Regarding Prescription Drug 
Marketing.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly available at 
https://www.regulations.gov, or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments

[[Page 6444]]

received, go to https://www.regulations.gov and insert the docket 
number, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Aaron Weisbuch, Center for Drug 
Evaluation and Research, Office of Compliance, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3130, <a href="/cdn-cgi/l/email-protection#6d3a29295e3d211f081c18041f08000803191e2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="b1e6f5f582e1fdc3d4c0c4d8c3d4dcd4dfc5c2f1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.
    With regard to biologics: Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Need for the Regulation
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective Dates
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend part 203 (21 CFR part 203) to reflect 
changes to affected provisions of the FD&C Act following enactment of 
the DSCSA, Title II of the DQSA (Pub. L. 113-54). In this proposed 
rulemaking, we are proposing to amend certain provisions of part 203 to 
avoid potential confusion with the new standards and requirements for 
wholesale distributors applicable under the FD&C Act (as amended by the 
DSCSA), and to make certain related, conforming changes.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would: (1) Modify the ``scope'' and ``purpose'' 
sections of the regulations in part 203 to eliminate references to 
wholesale distribution, (2) delete Subpart E--Wholesale Distribution in 
its entirety, (3) delete from Sec.  203.3 the definitions for terms 
that only appeared in subpart E, and (4) modify other provisions of 
part 203 to eliminate references to wholesale distribution to conform 
to the changes described above.

C. Legal Authority

    We are issuing this proposed rule under sections 503(c), 503(e), 
582, 583 and 701(a) of the FD&C Act (21 U.S.C. 353(c), 353(e), 360eee-
1, 360eee-2, and 371(a)).

D. Costs and Benefits

    This proposed rule is a companion to the proposed rule ``National 
Standards for the Licensure of Wholesale Drug Distributors and Third-
Party Logistics Providers'' (licensing standards proposed rule) which 
implements the national licensing standards requirements of DSCSA. The 
licensing standards proposed rule, which would amend part 205, is 
published elsewhere in this issue of the Federal Register. We analyze 
the effects of the two rules together; thus, we include the benefits 
and costs of this proposed rule in the regulatory impact analysis of 
the licensing standards proposed rule.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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           Abbreviation/acronym                     What it means
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CFR.......................................  Code of Federal Regulations.
DSCSA.....................................  Drug Supply Chain Security
                                             Act.
DQSA......................................  Drug Quality and Security
                                             Act.
FDA or the Agency.........................  U.S. Food and Drug
                                             Administration.
FD&C Act..................................  Federal Food, Drug, and
                                             Cosmetic Act.
U.S.C.....................................  United States Code.
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III. Background

A. Introduction

    The DQSA was enacted on November 27, 2013. The DQSA contains two 
titles: Title I, the Compounding Quality Act and Title II, the DSCSA. 
The DSCSA amended Chapter V of the FD&C Act by adding Subchapter H 
(Pharmaceutical Distribution Supply Chain), which includes new sections 
581 through 585 (21 U.S.C. 360eee through 360eee-4), and by amending 
section 503(e) of the FD&C Act. As amended, section 503(e) of the FD&C 
Act, together with new section 583 of the FD&C Act, require the 
Secretary of Health and Human Services (Secretary) \1\ to establish 
national prescription drug wholesale distributor licensure standards. 
In addition, section 582 of the FD&C Act establishes prescription drug 
product tracing requirements for wholesale distributors and their 
trading partners. FDA is proposing to revise the regulations in part 
203 by removing or amending those sections of the regulations that have 
been affected by the changes to the FD&C Act through the enactment of 
the DSCSA.
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    \1\ This function has been delegated to FDA.
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B. Need for the Regulation

    This rulemaking, when finalized, would: (1) Remove existing 
regulations regarding wholesale distribution of prescription drugs that 
conflict with or were superseded by new requirements established under 
the DSCSA; (2) modify other existing regulations for consistency with 
the regulations on standards for licensure of wholesale distributors 
that FDA is proposing pursuant to section 583 of the FD&C Act; and (3) 
make certain related, conforming changes. This rulemaking is needed to 
remove outdated regulations and to prevent confusion about requirements 
for wholesale distributors under the FD&C Act.

IV. Legal Authority

    The Agency is proposing this rule under the authority to impose 
requirements regarding prescription drug marketing and wholesale drug 
distribution granted to it under various sections of the FD&C Act, 
including sections 503(c), 503(e), 582, 583, and 701(a). Section 503(c) 
describes certain restrictions on prescription drug marketing, 
including relating to the sale of drug samples and of drugs that have 
been purchased by hospitals or other healthcare entities. Section 
503(e), together with section 583 of the FD&C Act, require the 
Secretary to establish national prescription drug wholesale distributor 
licensure standards, while section 582 describes requirements 
applicable to wholesale distributors and other entities related to 
product tracing. Section 701(a) provides general authority to issue 
regulations for the efficient enforcement of the FD&C Act. By 
clarifying provisions related to prescription drug marketing and by 
removing provisions relating to wholesale distribution, this rule, when 
finalized, is expected to aid in the efficient enforcement of the FD&C 
Act.

V. Description of the Proposed Rule

    This proposed rule would make the deletions and changes to the 
existing regulations in part 203 discussed below as well as technical 
changes for clarity.

[[Page 6445]]

1. Scope and Purpose (Sec. Sec.  203.1 and 203.2)
    Existing Sec. Sec.  203.1 and 203.2 describe the scope and purpose 
of the regulations in part 203, respectively. The proposed revisions 
would narrow the scope and purpose descriptions in light of the 
proposed elimination of requirements relating to wholesale distributors 
from part 203. We plan to address the standards and requirements 
related to wholesale distributor licensing elsewhere in our 
regulations, in accordance with the applicable provisions of the FD&C 
Act (as amended by the DSCSA).
2. Definitions (Sec.  203.3)
    Certain definitions that currently appear in this section would be 
modified or eliminated.
    a. Authorized distributor of record. The amendments to section 
503(e) effectuated by the DSCSA eliminated the definition of 
``authorized distributors of record'' from section 503(e) of the FD&C 
Act, which previously provided that the definition applied for the 
purposes of section 503(d) and 503(e). However, the DSCSA added a 
definition of the same term in section 503(d) of the FD&C Act, which 
relates to drug sample distribution, in section 503(d)(4). The 
``authorized distributor of record'' definition in Sec.  203.3 would be 
revised to reflect the fact that, as used in the amended part 203, the 
phrase would relate solely to distribution of drug samples. The revised 
``authorized distributor of record'' definition would be found in the 
new Sec.  203.3(a). In addition, as further discussed below, references 
to distribution of products by authorized distributors of record would 
be amended throughout the text of part 203, where appropriate, to 
clarify that these references relate only to distribution of drug 
samples.
    b. Emergency medical reasons. The proposed rule would amend the 
definition of ``emergency medical reasons'' in the new Sec.  203.3(l). 
Section 203.22, which sets forth exemptions from the sales restrictions 
described in Sec.  203.20, generally provides an exemption from those 
restrictions for sales, purchases, or trades of a drug for emergency 
medical reasons (Sec.  203.22(d)). Section 203.3(m) currently states, 
in part, that ``emergency medical reasons'' include, but are not 
limited to, transfers of a prescription drug between healthcare 
entities or from a healthcare entity to a retail pharmacy to alleviate 
a temporary shortage of a prescription drug arising from delays in or 
interruption of regular distribution schedules, as well as transfers of 
prescription drugs by a retail pharmacy to another retail pharmacy to 
alleviate a temporary shortage. As a result, under Sec.  203.22(d) such 
transfers to alleviate temporary shortages are exempt from the sales 
restrictions set forth in Sec.  203.20. Certain of those transfers may, 
however, constitute ``wholesale distribution'' as defined in the DSCSA 
(section 503(e)(4) of the FD&C Act) because, while the ``wholesale 
distribution'' definition generally excludes distributions for 
``emergency medical reasons,'' it states that a drug shortage not 
caused by a public health emergency shall not constitute an emergency 
medical reason. With certain exceptions, a person cannot simultaneously 
be a healthcare entity and a wholesale distributor (see Sec.  
203.3(p)). Because of this, FDA proposes to amend relevant language in 
the ``emergency medical reasons'' definition to clarify the 
relationship between it and the definition of ``wholesale 
distribution'' in section 503(e)(4) of the FD&C Act. In particular, we 
would add text to Sec.  203.3(l) to make clear that a transfer made to 
alleviate a temporary shortage would generally be considered to be for 
``emergency medical reasons'' for purposes of part 203 only where the 
transfer was either to fulfill a specific patient need or where the 
shortage was caused by a public health emergency (that is, where such 
transfers would not constitute ``wholesale distribution'' as defined in 
section 503(e)(4) of the FD&C Act). As explained in our companion 
proposed rulemaking for part 205 (21 CFR part 205), the Agency 
considers the transfer or sale of a drug from one dispenser to another 
dispenser made to fulfill a specific patient need to be outside the 
scope of the ``wholesale distribution'' definition in section 503(e)(4) 
of the FD&C Act.
    c. Unauthorized distributor and wholesale distribution. The 
definitions of ``unauthorized distributor'' and ``wholesale 
distribution,'' currently codified in Sec.  203.3(bb) and (cc), 
respectively, would be eliminated from part 203, because these terms 
would no longer appear in part 203, as amended. The definition of the 
term ``wholesale distributor'' would be modified to indicate that the 
term would have the meaning set forth in section 581(29) of the FD&C 
Act.
3. Exclusions (Sec.  203.22(h) and (i))
    Paragraphs (h) and (i) of Sec.  203.22, which set forth exemptions 
from the sales restrictions in Sec.  203.20, would be modified to 
eliminate the phrase indicating that the applicable requirements for a 
wholesale distributor or retail pharmacy are contained in part 203, 
because FDA is proposing to remove Sec.  203.50, as discussed in 
section V.5.
4. Subpart D--Samples
    FDA would replace the term ``distributor'' where it appears in 
subpart D with the phrase ``authorized distributor of record'' where 
that phrase is not already used (Sec. Sec.  203.30, 203.31, 203.34, 
203.36, and 203.37). As noted above, the DSCSA added a definition of 
``authorized distributors of record'' in section 503(d) of the FD&C 
Act, which relates to drug sample distribution.
5. Subpart E--Wholesale Distribution
    FDA proposes to remove Sec.  203.50 (Subpart E--Wholesale 
Distribution) in its entirety. On July 14, 2011, FDA proposed to remove 
Sec.  203.50(a) (76 FR 41434). Before that rulemaking was finalized, 
the DSCSA was enacted. The DSCSA replaced section 503(e)(1)-(3) of the 
FD&C Act and added additional and different requirements for wholesale 
distributors. The DSCSA also added new requirements for wholesale 
distributors, including phased-in prescription drug tracing 
requirements in section 582(c) of the FD&C Act. FDA is withdrawing the 
above referenced July 14, 2011, proposed rule in a document published 
elsewhere in this issue of the Federal Register. In accordance with the 
changes in statutory authorities, FDA proposes to remove Sec.  203.50 
in its entirety. FDA is proposing new requirements for wholesale 
distributors and wholesale distribution consistent with the relevant 
provisions of the DSCSA in a separate proposed rulemaking for part 205, 
also published in this issue of the Federal Register.

VI. Proposed Effective Date

    This regulation, if finalized as proposed, will be effective 30 
calendar days after the date the final rule publishes in the Federal 
Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health

[[Page 6446]]

and safety, and other advantages; distributive impacts; and equity). We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the proposed rule imposes only minimal one-time costs 
of less than $100 per entity to read and understand the rule on small 
entities, we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    We include the costs to read and understand this proposed rule in 
the regulatory impact analysis of the companion licensing standards 
proposed rule. The full preliminary analysis of economic impacts of 
both rules is available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm under 
``National Standards for Licensing of Prescription Drug Wholesale 
Distributor and Third Party Logistics Providers'' (Ref. 1).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30 that this action is of the 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XII. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.

    1. Preliminary Regulatory Impact Analysis, Initial Regulatory 
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for 
Certain Requirements Regarding Prescription Drug Marketing; Proposed 
Rule, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 203

    Labeling, Prescription drugs, Reporting and recordkeeping 
requirements, Warehouses.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 203 be amended as follows:

PART 203--PRESCRIPTION DRUG MARKETING

0
1. The authority citation for part 203 continues to read as follows:

    Authority:  21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374, 
381.

0
2. In part 203, remove the words ``the act'' wherever they appear and 
add in their place ``the Federal Food, Drug, and Cosmetic Act''.
0
3. Revise Sec.  203.1 to read as follows:


Sec.  203.1  Scope.

    This part sets forth procedures and requirements pertaining to the 
reimportation of prescription drugs, including both bulk drug 
substances and finished dosage forms; the sale, purchase, or trade of 
(or the offer to sell, purchase, or trade) prescription drugs, 
including bulk drug substances, that were purchased by hospitals or 
healthcare entities, or donated to charitable organizations; and the 
distribution of prescription drug samples. For purposes of this part, 
the term ``prescription drug'' has the meaning set forth in Sec.  
203.3(x).
0
4. Revise Sec.  203.2 to read as follows:


Sec.  203.2  Purpose.

    The purpose of this part is to protect the public against drug 
diversion and enhance the security of the drug supply chain by 
establishing procedures and requirements relating to the reimportation 
of prescription drugs, the distribution of prescription drug samples, 
and the sale, purchase, or trade of prescription drugs purchased by 
hospitals or healthcare entities or donated to charitable 
organizations.
0
5. Revise Sec.  203.3 to read as follows:


Sec.  203.3   Definitions.

    (a) Authorized distributor of record means a distributor with whom 
a manufacturer has established an ongoing relationship to distribute 
such manufacturer's drug samples.
    (b) Blood means whole blood collected from a single donor and 
processed either for transfusion or further manufacturing.
    (c) Blood component means that part of a single-donor unit of blood 
separated by physical or mechanical means.
    (d) Bulk drug substance means any substance that is represented for 
use in a drug and that, when used in the manufacturing, processing, or 
packaging of a drug, becomes an active ingredient or a finished dosage 
form of the drug, but the term does not include intermediates used in 
the synthesis of such substances.
    (e) Charitable institution or charitable organization means a 
nonprofit hospital, healthcare entity, organization, institution, 
foundation, association, or corporation that has been granted an 
exemption under section 501(c)(3) of the Internal Revenue Code of 1954, 
as amended.

[[Page 6447]]

    (f) Common control means the power to direct or cause the direction 
of the management and policies of a person or an organization, whether 
by ownership of stock, voting rights, by contract, or otherwise.
    (g) Distribute means to sell, offer to sell, deliver, or offer to 
deliver a drug to a recipient, except that the term ``distribute'' does 
not include:
    (1) Delivering or offering to deliver a drug by a common carrier in 
the usual course of business as a common carrier; or
    (2) Providing of a drug sample to a patient by:
    (i) A practitioner licensed to prescribe such drug;
    (ii) A healthcare professional acting at the direction and under 
the supervision of such a practitioner; or
    (iii) The pharmacy of a hospital or of another healthcare entity 
that is acting at the direction of such a practitioner and that 
received such sample in accordance with the Federal Food, Drug, and 
Cosmetic Act and the regulations in this part.
    (h) Drug sample means a unit of a prescription drug that is not 
intended to be sold and is intended to promote the sale of the drug.
    (i) Drug coupon means a form that may be redeemed, at no cost or at 
reduced cost, for a drug that is prescribed in accordance with section 
503(b) of the Federal Food, Drug, and Cosmetic Act.
    (j) Electronic record means any combination of text, graphics, 
data, audio, pictorial, or other information representation in digital 
form that is created, modified, maintained, archived, retrieved, or 
distributed by a computer system.
    (k) Electronic signature means any computer data compilation of any 
symbol or series of symbols executed, adopted, or authorized by an 
individual to be the legally binding equivalent of the individual's 
handwritten signature.
    (l) Emergency medical reasons include, but are not limited to:
    (1) Transfers of a prescription drug between healthcare entities or 
from a healthcare entity to a retail pharmacy to alleviate a temporary 
shortage of a prescription drug arising from delays in or interruption 
of regular distribution schedules, provided that such transfers are 
made in order to fulfill a specific patient need or respond to a public 
health emergency;
    (2) Sales to nearby emergency medical services, i.e., ambulance 
companies, police, and fire-fighting organizations in the same State or 
same marketing or service area, or nearby licensed practitioners, of 
drugs for use in the treatment of acutely ill or injured persons;
    (3) Provision of minimal emergency supplies of drugs to nearby 
nursing homes for use in emergencies or during hours of the day when 
necessary drugs cannot be obtained; and
    (4) Transfers of prescription drugs by a retail pharmacy to another 
retail pharmacy to alleviate a temporary shortage, provided that such 
transfers are made in order to fulfill a specific patient need or 
respond to a public health emergency but do not include regular and 
systematic sales to licensed practitioners of prescription drugs that 
will be used for routine office procedures.
    (m) FDA means the U.S. Food and Drug Administration.
    (n) Group purchasing organization means any entity established, 
maintained, and operated for the purchase of prescription drugs for 
distribution exclusively to its members with such membership consisting 
solely of hospitals and healthcare entities bound by written contract 
with the entity.
    (o) Handwritten signature means the scripted name or legal mark of 
an individual handwritten by that individual and executed or adopted 
with the present intention to authenticate a writing in a permanent 
form. The act of signing with a writing or marking instrument such as a 
pen or stylus is preserved. The scripted name or legal mark, while 
conventionally applied to paper, may also be applied to other devices 
that capture the name or mark.
    (p) Healthcare entity means any person that provides diagnostic, 
medical, surgical, or dental treatment, or chronic or rehabilitative 
care, but does not include any retail pharmacy or any wholesale 
distributor. Except as provided in Sec.  203.22(h) and (i), a person 
cannot simultaneously be a ``healthcare entity'' and a retail pharmacy 
or wholesale distributor.
    (q) Licensed practitioner means any person licensed or authorized 
by State law to prescribe drugs.
    (r) Manufacturer means any person who is a manufacturer as defined 
by Sec.  201.1 of this chapter.
    (s) Nonprofit affiliate means any not-for-profit organization that 
is either associated with or a subsidiary of a charitable organization 
as defined in section 501(c)(3) of the Internal Revenue Code of 1954.
    (t) Ongoing relationship means 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 
drug samples for a period of time or for a number of shipments. If the 
distributor is not authorized to distribute a manufacturer's entire 
drug sample line, the agreement must identify the specific drug samples 
that the distributor is authorized to distribute.
    (u) PDA means the Prescription Drug Amendments of 1992.
    (v) PDMA means the Prescription Drug Marketing Act of 1987.
    (w) Person includes any individual, partnership, corporation, or 
association.
    (x) Prescription drug means any drug (including any biological 
product, except for blood and blood components intended for transfusion 
or biological products that are also medical devices) required by 
Federal law (including Federal regulation) to be dispensed only by a 
prescription, including finished dosage forms and bulk drug substances 
subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act.
    (y) Representative means an employee or agent of a drug 
manufacturer or authorized distributor of record who promotes the sale 
of prescription drugs to licensed practitioners and who may solicit or 
receive written requests for the delivery of drug samples. A detailer 
is a representative.
    (z) Sample unit means a packet, card, blister pack, bottle, 
container, or other single package comprised of one or more dosage 
units of a prescription drug sample, intended by the manufacturer or 
authorized distributor of record to be provided by a licensed 
practitioner to a patient in an unbroken or unopened condition.
    (aa) Wholesale distributor has the meaning set forth in section 
581(29) of the Federal Food, Drug, and Cosmetic Act.
0
6. In Sec.  203.22, revise paragraphs (h) and (i) to read as follows:


Sec.  203.22  Exclusions.

* * * * *
    (h) The sale, purchase, or trade of, or the offer to sell, 
purchase, or trade, by a registered blood establishment that qualifies 
as a healthcare entity, any:
    (1) Drug indicated for a bleeding or clotting disorder, or anemia;
    (2) Blood collection container approved under section 505 of the 
Federal Food, Drug, and Cosmetic Act; or
    (3) Drug that is a blood derivative (or a recombinant or synthetic 
form of a blood derivative); as long as all of the healthcare services 
that the establishment provides are related to its activities as a 
registered blood establishment or the healthcare services consist of 
collecting, processing, storing,

[[Page 6448]]

or administering human hematopoietic stem/progenitor cells or 
performing diagnostic testing of specimens provided that these 
specimens are tested together with specimens undergoing routine donor 
testing. Blood establishments relying on the exclusion in this 
paragraph (h)(3) must satisfy all other applicable requirements of the 
Federal Food, Drug, and Cosmetic Act and the regulations in this part 
promulgated thereunder.
    (i) The sale, purchase, or trade of, or the offer to sell, 
purchase, or trade, by a comprehensive hemophilia diagnostic treatment 
center that is receiving a grant under section 501(a)(2) of the Social 
Security Act and that qualifies as a healthcare entity, any drug 
indicated for a bleeding or clotting disorder, or anemia, or any drug 
that is a blood derivative (or a recombinant or synthetic form of a 
blood derivative). Comprehensive hemophilia diagnostic treatment 
centers relying on the exclusion in this paragraph (i) must satisfy all 
other applicable requirements of the Social Security Act and the 
regulations in this part promulgated thereunder.
0
7. In Sec.  203.30, revise paragraphs (a)(4) and (c) to read as 
follows:


Sec.  203.30  Sample distribution by mail or common carrier.

    (a) * * *
    (4) The receipt is returned to the manufacturer or authorized 
distributor of record from which the drug sample was received.
* * * * *
    (c) Contents of the receipt to be completed upon delivery of a drug 
sample. The receipt is to be on a form designated by the manufacturer 
or authorized distributor of record, and is required to contain the 
following:
    (1) If the drug sample is delivered to the licensed practitioner 
who requested it, the receipt is required to contain the name, address, 
professional title, and signature of the practitioner or the 
practitioner's designee who acknowledges delivery of the drug sample; 
the proprietary or established name and strength of the drug sample; 
the quantity of the drug sample delivered; and the date of the 
delivery.
    (2) If the drug sample is delivered to the pharmacy of a hospital 
or other healthcare entity at the request of a licensed practitioner, 
the receipt is required to contain the name and address of the 
requesting licensed practitioner; the name and address of the hospital 
or healthcare entity pharmacy designated to receive the drug sample; 
the name, address, professional title, and signature of the person 
acknowledging delivery of the drug sample; the proprietary or 
established name and strength of the drug sample; the quantity of the 
drug sample delivered; and the date of the delivery.
0
8. In Sec.  203.31, revise paragraphs (a)(4), (c), (d) introductory 
text, (d)(2)(iii), and (e) to read as follows:


Sec.  203.31  Sample distribution by means other than mail or common 
carrier (direct delivery by a representative or detailer).

    (a) * * *
    (4) The receipt is returned to the manufacturer or authorized 
distributor of record; and
* * * * *
    (c) Contents of the receipt to be completed upon delivery of a drug 
sample. The receipt is to be on a form designated by the manufacturer 
or authorized distributor of record, and is required to contain the 
following:
    (1) If the drug sample is received at the address of the licensed 
practitioner who requested it, the receipt is required to contain the 
name, address, professional title, and signature of the practitioner or 
the practitioner's designee who acknowledges delivery of the drug 
sample; the proprietary or established name and strength of the drug 
sample; the quantity of the drug sample delivered; and the date of the 
delivery.
    (2) If the drug sample is received by the pharmacy of a hospital or 
other healthcare entity at the request of a licensed practitioner, the 
receipt is required to contain the name and address of the requesting 
licensed practitioner; the name and address of the hospital or 
healthcare entity pharmacy designated to receive the drug sample; the 
name, address, professional title, and signature of the person 
acknowledging delivery of the drug sample; the proprietary or 
established name and strength of the drug sample; the quantity of the 
drug sample delivered; and the date of the delivery.
    (d) Inventory and reconciliation of drug samples of manufacturers' 
and authorized distributors' representatives. Each drug manufacturer or 
authorized distributor of record that distributes drug samples by means 
of representatives shall conduct, at least annually, a complete and 
accurate physical inventory of all drug samples. All drug samples in 
the possession or control of each manufacturer's and authorized 
distributor's representatives are required to be inventoried and the 
results of the inventory are required to be recorded in an inventory 
record, as specified in paragraph (d)(1) of this section. In addition, 
manufacturers and authorized distributors of record shall reconcile the 
results of the physical inventory with the most recently completed 
prior physical inventory and create a report documenting the 
reconciliation process, as specified in paragraph (d)(2) of this 
section.
* * * * *
    (2) * * *
    (iii) A record of drug sample distributions since the most recently 
completed inventory showing the name and address of each recipient of 
each sample unit shipped, the date of the shipment, and the proprietary 
or established name, dosage strength, and number of sample units 
shipped. For the purposes of this paragraph (d)(2)(iii) and paragraph 
(d)(2)(v) of this section, ``distributions'' includes distributions to 
healthcare practitioners or designated hospital or healthcare entity 
pharmacies, transfers or exchanges with other firm representatives, 
returns to the manufacturer or authorized distributor of record, 
destruction of drug samples by a sales representative, and other types 
of drug sample dispositions. The specific type of distribution must be 
specified in the record;
* * * * *
    (e) Lists of manufacturers' and authorized distributors' 
representatives. Each drug manufacturer or authorized distributor of 
record who distributes drug samples by means of representatives shall 
maintain a list of the names and addresses of its representatives who 
distribute drug samples and of the sites where drug samples are stored.
0
9. In Sec.  203.34, revise paragraph (b)(1) to read as follows:


Sec.  203.34  Policies and procedures; administrative systems.

* * * * *
    (b) * * *
    (1) Reconciling requests and receipts, identifying patterns of 
nonresponse, and the manufacturer's or authorized distributor of 
record's response when such patterns are found;
* * * * *
0
10. In Sec.  203.36, revise paragraph (a) to read as follows:


Sec.  203.36  Fulfillment houses, shipping and mailing services, 
comarketing agreements, and third-party recordkeeping.

    (a) Responsibility for creating and maintaining forms, reports, and 
records. Any manufacturer or authorized distributor of record that uses 
a fulfillment house, shipping or mailing service, or other third party, 
or engages in a comarketing agreement with another manufacturer or 
authorized distributor of record to distribute drug samples or to meet 
any of the

[[Page 6449]]

requirements of PDMA, PDA, or this part, remains responsible for 
creating and maintaining all requests, receipts, forms, reports, and 
records required under PDMA, PDA, and this part.
* * * * *
0
11. In Sec.  203.37, revise paragraph (e) to read as follows:


Sec.  203.37  Investigation and notification requirements.

* * * * *
    (e) Whom to notify at FDA. Notifications and reports concerning 
samples of human prescription drugs or biological products that are 
regulated by the Center for Drug Evaluation and Research shall be made 
via email to <a href="/cdn-cgi/l/email-protection#e6b6a2aba7b4a3b6a9b4b2b5a6808287c88e8e95c8818990"><span class="__cf_email__" data-cfemail="edbda9a0acbfa8bda2bfb9bead8b898cc385859ec38a829b">[email protected]</span></a>. Alternatively, reports and 
correspondence concerning such samples may be made via regular mail to 
the Office of Drug Security, Integrity, and Response, Office of 
Compliance, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD 
20993-0002, ATTN: PDMA Reports. Notifications and reports concerning 
samples of human prescription biological products regulated by the 
Center for Biologics Evaluation and Research shall be made to the Food 
and Drug Administration, Center for Biologics Evaluation and Research, 
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, 
Silver Spring, MD 20993-0002.

Subpart E [Removed and Reserved]

0
12. Remove and reserve subpart E, consisting of Sec.  203.50.

    Dated: January 24, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-01927 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


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