Rule2023-18899
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies, Revision 1; Guidance for Industry; Availability
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Published
September 1, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies, Revision 1." This revised guidance explains that FDA intends to extend for an additional year (from November 27, 2023, to November 27, 2024), the enforcement policies described in the guidance entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies," published in the Federal Register on October 23, 2020 (the 2020 Compliance Policies). The 2020 Compliance Policies relate to provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), requiring wholesale distributors to verify the product identifier prior to further distributing saleable returned product and requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser's possession or control.
Full Text
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<title>Federal Register, Volume 88 Issue 169 (Friday, September 1, 2023)</title>
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[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Rules and Regulations]
[Pages 60333-60336]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18899]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2019-D-4212]
Wholesale Distributor Verification Requirement for Saleable
Returned Drug Product and Dispenser Verification Requirements When
Investigating a Suspect or Illegitimate Product--Compliance Policies,
Revision 1; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notification of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Wholesale
Distributor Verification Requirement for Saleable Returned Drug Product
and Dispenser Verification Requirements When Investigating a Suspect or
Illegitimate Product--Compliance Policies, Revision 1.'' This revised
guidance explains that FDA intends to extend for an additional year
(from November 27, 2023, to November 27, 2024), the enforcement
policies
[[Page 60334]]
described in the guidance entitled ``Wholesale Distributor Verification
Requirement for Saleable Returned Drug Product and Dispenser
Verification Requirements When Investigating a Suspect or Illegitimate
Product--Compliance Policies,'' published in the Federal Register on
October 23, 2020 (the 2020 Compliance Policies). The 2020 Compliance
Policies relate to provisions in the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA),
requiring wholesale distributors to verify the product identifier prior
to further distributing saleable returned product and requiring
dispensers to verify the product identifier for suspect or illegitimate
product in the dispenser's possession or control.
DATES: The announcement of the guidance is published in the Federal
Register on September 1, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
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-2019-D-4212 for ``Wholesale Distributor Verification Requirement
for Saleable Returned Drug Product and Dispenser Verification
Requirements When Investigating a Suspect or Illegitimate Product--
Compliance Policies.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Sarah Venti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
<a href="/cdn-cgi/l/email-protection#f3978186948781929098929d978781929096b3959792dd9b9b80dd949c85"><span class="__cf_email__" data-cfemail="2145535446555340424a404f455553404244614745400f4949520f464e57">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On October 23, 2020, FDA published the 2020 Compliance Policies.
FDA is announcing the availability of a guidance for industry entitled
``Wholesale Distributor Verification Requirement for Saleable Returned
Drug Product and Dispenser Verification Requirements When Investigating
a Suspect or Illegitimate Product--Compliance Policies, Revision 1'',
which extends the enforcement policies described in the 2020 Compliance
Policies for an additional year, from November 27, 2023, until November
27, 2024. As described in this revised guidance, FDA does not intend to
take enforcement action, prior to November 27, 2024, against wholesale
distributors who do not verify the product identifier prior to further
distributing saleable returned product, or against dispensers who do
not verify the product identifier of the statutorily designated
proportion of suspect or illegitimate product in the dispenser's
possession or control, as required under section 582 of the FD&C Act
(21 U.S.C. 360eee-1), as added by the DSCSA (Title II of Pub. L. 113-
54).
This revised guidance is being issued consistent with FDA's good
guidance practices regulations (21 CFR 10.115). FDA is implementing
this guidance without prior public comment because the Agency has
determined that prior public participation is not feasible or
appropriate (21 CFR 10.115(g)(2)). FDA made this determination because
this guidance document provides information pertaining to statutory
requirements that FDA had planned to begin enforcing as of November 27,
[[Page 60335]]
2023, for wholesale distributors to verify the product identifier prior
to further distributing saleable returned product under section
582(c)(4)(D) of the FD&C Act and for dispensers to verify the product
identifier, including the standardized numerical identifier, for
suspect or illegitimate product in the dispenser's possession or
control under section 582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the
FD&C Act. It is important that FDA provide this information before that
date. Although this guidance document is being implemented immediately,
it remains subject to comment in accordance with the Agency's good
guidance practices (21 CFR 10.115(g)(3)).
Beginning November 27, 2019, wholesale distributors were required,
under section 582(c)(4)(D) of the FD&C Act, to verify the product
identifier, including the standardized numerical identifier, on each
sealed homogeneous case of saleable returned product, or, if such
product is not in a sealed homogeneous case, on each package of
saleable returned product, prior to further distributing such returned
product. In the Federal Register published September 24, 2019 (84 FR
50044), FDA issued a notice announcing the availability of the
Wholesale Distributor Verification Requirement for Saleable Returned
Drug Product--Compliance Policy guidance (2019 Compliance Policy),
which described a 1-year enforcement policy with respect to this
wholesale distributor requirement, until November 27, 2020. The Agency
subsequently published the 2020 Compliance Policies, which extended the
enforcement policy in the 2019 Compliance Policy with respect to this
wholesale distributor requirement for 3 years, until November 27, 2023,
and also included an enforcement policy until that same date with
respect to the requirement for dispensers to verify the product
identifier, including the standardized numerical identifier, for
suspect or illegitimate product in the dispenser's possession or
control.
Since the announcement of the 2020 Compliance Policies, FDA has
received additional comments and feedback from wholesale distributors,
as well as other trading partners and stakeholders, expressing concern
with industry-wide readiness for implementation of the verification of
saleable returned product requirement for wholesale distributors and
the challenges stakeholders face with developing interoperable,
electronic systems to enable such verification and achieve
interoperability between networks. Specifically, comments received
point out continuing challenges posed by the large volume of saleable
returned product, explaining that wholesale distributors still need
more time to test verification systems using real-time volumes of
saleable returned product with all trading partners involved, as
opposed to using small-scale pilot test projects. Given all these
concerns, FDA recognizes that some wholesale distributors may need
additional time, beyond November 27, 2023, before they can begin
verifying returned products prior to resale or other further
distribution as required by section 582(c)(4)(D) of the FD&C Act in an
efficient, secure, and timely manner. Additionally, section 582 of the
FD&C Act requires certain trading partners (manufacturers, repackagers,
wholesale distributors, and dispensers) to exchange transaction
information, transaction history, and a transaction statement when
engaging in transactions involving certain prescription drugs. Section
581(27)(E) of the FD&C Act (21 U.S.C. 360eee(27)(E)) requires that the
transaction statement include a statement that the entity transferring
ownership in a transaction had systems and processes in place to comply
with verification requirements under section 582 of the FD&C Act. This
revised guidance also explains that, prior to November 27, 2024, FDA
does not intend to take action against a wholesale distributor for
providing a transaction statement to a subsequent purchaser of product
on the basis that such wholesale distributor does not yet have systems
and processes in place to comply with the saleable return verification
requirements under section 582(c)(4)(D) of the FD&C Act. The guidance
explains the scope of the compliance policy in further detail.
In addition to helping minimize possible disruptions in the
distribution of certain prescription drugs in the United States, FDA
believes that by extending the enforcement approach described in the
2020 Compliance Policies until November 27, 2024, wholesale
distributors will be able to focus resources and efforts on the
requirements for enhanced drug distribution security under section
582(g) of the FD&C Act (as described below). Thus, instead of
developing separate processes or infrastructures solely for the
saleable return verification requirement, wholesale distributors can
incorporate the saleable return verification requirements into the
enhanced verification required under section 582(g) of the FD&C Act.
Further, section 582 of the FD&C Act, as added by the DSCSA, also
established the requirements that specify how dispensers must
investigate suspect and illegitimate product. As part of the
investigation, section 582(d)(4)(A)(ii)(II) of the FD&C Act requires
dispensers to verify the product identifier, including the standardized
numerical identifier, of at least three packages or 10 percent of such
suspect product, whichever is greater, or all packages, if there are
fewer than three, corresponds with the product identifier for such
product in the dispenser's possession or control. Section
582(d)(4)(B)(iii) of the FD&C Act requires dispensers to verify product
as described in section 582(d)(4)(A)(ii), which includes the section
582(d)(4)(A)(ii)(II) requirement, in response to a notification from
FDA or a trading partner that the product is an illegitimate product.
In response to comments received from stakeholders regarding
dispenser readiness to meet these requirements, and to minimize
possible disruptions in the distribution of affected prescription drugs
in the United States, this guidance also announces that FDA does not
intend to take action before November 27, 2024, against dispensers who
do not verify the product identifier of the statutorily designated
proportion of suspect product as required by section
582(d)(4)(A)(ii)(II) of the FD&C Act, and that part of section
582(d)(4)(B)(iii) of the FD&C Act that requires dispensers to perform
the same verification activities of section 582(d)(4)(A)(ii)(II) when
responding to a notification of illegitimate product from FDA or
another trading partner. FDA believes that the 1-year extension under
this guidance of the applicable 2020 Compliance Policies will
facilitate the ability of dispensers to ensure the systems and
processes that are put into place to meet the enhanced drug
distribution security requirements, which FDA will generally not
enforce before November 27, 2024, will also fulfill the dispenser
verification requirements under section 582(d)(4) of the FD&C Act.
In the ``Enhanced Drug Distribution Security Requirements Under
Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--
Compliance Policies'' (Enhanced Drug Distribution Security Compliance
Policies) (88 FR 58498), FDA announced a 1-year enforcement policy with
respect to the enhanced drug distribution security requirements set to
take effect on November 27, 2023. FDA chose to adopt this enforcement
policy until November 27, 2024, because FDA was aware that some
stakeholders were facing challenges with implementing the section
582(g) requirements and needed additional time to comply with these
requirements.
While FDA generally expects trading partners to have the systems
and
[[Page 60336]]
processes in place to meet the requirements of section 582(g) of the
FD&C Act, FDA recognizes that some technical and operational issues may
not be fully resolved by November 27, 2023. The Agency believes the
Enhanced Drug Distribution Security Compliance Policies can help
trading partners address such issues by accommodating the additional
time that may be needed to implement, troubleshoot, and mature their
systems and processes. For additional information about enhanced drug
distribution security please see the June 2021 draft guidance for
industry entitled ``Enhanced Drug Distribution Security at the Package
Level Under the Drug Supply Chain Security Act'' (available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act</a>).
This guidance represents the current thinking of FDA on ``Wholesale
Distributor Verification Requirement for Saleable Returned Drug Product
and Dispenser Verification Requirements When Investigating a Suspect or
Illegitimate Product--Compliance Policies.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.\1\
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\1\ The Office of the Federal Register has published this
document under the category ``Rules and Regulations'' pursuant to
its interpretation of 1 CFR 5.9(b). We note that the categorization
as such for purposes of publication in the Federal Register does not
affect the content or intent of the document. See 1 CFR 5.1(c).
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II. Paperwork Reduction Act of 1995
FDA concludes that this guidance contains no collection of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
either <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18899 Filed 8-31-23; 8:45 am]
BILLING CODE 4164-01-P
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