Proposed Rule2022-01927
Certain Requirements Regarding Prescription Drug Marketing
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 4, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This action, if finalized, will remove or revise outdated and conflicting regulatory requirements to align with changes to affected provisions of the FD&C Act following enactment of the DSCSA.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 This action, if finalized, will remove or revise outdated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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments
[[Page 6444]]
received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm">https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm</a>.
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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</html>Indexed from Federal Register on February 4, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.