Notice2023-26846
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability
Primary source
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Published
December 7, 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 final guidance for industry entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." The guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, the guidance covers the statutory verification systems requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. The guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser (also referred to as "trading partners") after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, the guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns. The guidance finalizes the revised draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs," issued on March 10, 2022.
Full Text
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<title>Federal Register, Volume 88 Issue 234 (Thursday, December 7, 2023)</title>
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[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85295-85296]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26846]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3462]
Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs.'' The guidance addresses the verification
systems that manufacturers, repackagers, wholesale distributors, and
dispensers must have in place to comply with the Federal Food, Drug,
and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain
Security Act (DSCSA). Specifically, the guidance covers the statutory
verification systems requirements that include the quarantine and
investigation of a product determined to be suspect and the quarantine
and disposition of a product determined to be illegitimate. The
guidance also addresses the statutory requirement for notification to
the Agency of a product that has been cleared by a manufacturer,
repackager, wholesale distributor, or dispenser (also referred to as
``trading partners'') after a suspect product investigation because it
is determined that the product is not an illegitimate product. Finally,
the guidance addresses the statutory requirement for responding to
requests for verification and processing saleable returns. The guidance
finalizes the revised draft guidance ``Verification Systems Under the
Drug Supply Chain Security Act for Certain Prescription Drugs,'' issued
on March 10, 2022.
DATES: The announcement of the guidance is published in the Federal
Register on December 7, 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-2018-D-3462 for ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs; Guidance for Industry;
Availability.'' 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 this 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; or to Office of
Communication, Outreach and Development, Center for
[[Page 85296]]
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, 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, Office of Compliance,
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#1c786e697b686e7d7f777d7278686e7d7f795c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="89edfbfceefdfbe8eae2e8e7edfdfbe8eaecc9efede8a7e1e1faa7eee6ff">[email protected]</span></a>; or Anne Taylor, 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:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Verification Systems Under the Drug Supply Chain Security
Act for Certain Prescription Drugs.'' The DSCSA (title II of Pub. L.
113-54) was signed into law on November 27, 2013. Section 202 of the
DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which
established the requirement that trading partners have systems in place
to enable them to comply with certain verification obligations. This
guidance provides recommendations for robust verification systems for
the determination, quarantine, and investigation of suspect products,
as well as the quarantine, notification, and disposition of
illegitimate products. This guidance also addresses the manner in which
FDA recommends that trading partners submit cleared product
notifications (i.e., notifications that a suspect product is not an
illegitimate product), the statutory requirements for responding to
requests for verification, and the statutory requirements for
processing saleable returns.
FDA initially published the draft guidance ``Verification Systems
Under the Drug Supply Chain Security Act for Certain Prescription
Drugs'' on October 25, 2018 (83 FR 53880). Comments were received on
the initial draft guidance and the Agency made revisions to the draft.
This guidance finalizes the revised draft guidance entitled
``Verification Systems Under the Drug Supply Chain Security Act for
Certain Prescription Drugs,'' issued on March 10, 2022 (87 FR 13738).
FDA considered comments received on the revised draft guidance in
finalizing this guidance. Changes from the revised draft to the final
guidance include: (1) clarifying that dispensers need not provide
transaction information for saleable return product; (2) clarifying
that ``verification'' as defined in section 581 of the FD&C Act (21
U.S.C. 360eee) involves confirming that the product identifier affixed
or imprinted upon a package or homogeneous case corresponds to the
Standardized Numerical Identifier or lot number and expiration date
assigned to the product by the manufacturer or repackager by more
closely mirroring the statutory language; (3) further clarifying when
the discussion is about the verification systems requirements in
section 582 of the FD&C Act and when it is about the requirement to
verify the product identifier; (4) clarifying FDA's understanding about
the statutory requirement that manufacturers and repackagers respond to
requests for verification within 24 hours or within other such
reasonable time as determined by the Secretary of Health and Human
Services; (5) clarifying that when a trading partner does not receive a
timely response to a verification request, the product that is the
subject of the request need not automatically be classified as suspect;
and (6) clarifying that certain system attributes are suggested as best
practices even though they are not specifically required under the
DSCSA. In addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Verification Systems Under the Drug Supply
Chain Security Act for Certain Prescription Drugs.'' 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.
II. Paperwork Reduction Act
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
pertaining to implementation of the Drug Supply Chain Security Act are
approved in OMB control no. 0910-0806.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26846 Filed 12-6-23; 8:45 am]
BILLING CODE 4164-01-P
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