Notice2022-05018
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability
Primary source
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Published
March 10, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs." This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food,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 Specifically, this revised draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine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 The revised draft guidance also addresses the statutory requirement for notification to the Agency of a product that has been cleared by a manufacturer, repackager, wholesale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 Finally, the revised draft guidance addresses the statutory requirement for responding to requests for verification and processing saleable returns.
Full Text
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<title>Federal Register, Volume 87 Issue 47 (Thursday, March 10, 2022)</title>
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[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Notices]
[Pages 13738-13739]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05018]
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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Certain Prescription Drugs; Draft Guidance for Industry; Availability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 revised draft guidance entitled ``Verification
Systems Under the Drug Supply Chain Security Act for Certain
Prescription Drugs.'' This revised draft 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, this revised draft
guidance covers the statutory verification system 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 revised draft 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 revised draft guidance addresses
the statutory requirement for responding to requests for verification
and processing saleable returns.
DATES: The announcement of the guidance is published in the Federal
Register on March 10, 2022.
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; Draft 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)).
[[Page 13739]]
Submit written requests for single copies of the draft 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 the office in processing your
requests. The guidance may also be obtained by mail by calling CDER at
at 1-800-835-4709 or 240-402-8010. 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#c7a3b5b2a0b3b5a6a4aca6a9a3b3b5a6a4a287a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="7b1f090e1c0f091a18101a151f0f091a181e3b1d1f1a55131308551c140d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft 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 revised draft 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 revised
draft 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.
In the Federal Register of October 25, 2018 (83 FR 53880), FDA
announced the availability of a draft guidance entitled ``Verification
Systems Under the Drug Supply Chain Security Act for Certain
Prescription Drugs'' dated October 24, 2018. FDA received several
comments on the draft guidance, which have been taken into
consideration. In response to comments received from stakeholders, this
draft guidance revises the October 2018 draft guidance to: (1) Provide
FDA's interpretation of what ``possession or control'' means as used
throughout the DSCSA; (2) explain that the guidance uses the term
verification in referring to both the broad set of requirements set
forth in paragraphs (b)(4), (c)(4), (d)(4), and (e)(4) of section 582
of the FD&C Act in addition to using the term with the meaning defined
in section 581(28) of the FD&C Act, where appropriate to the context;
(3) recognize that, in cases where the DSCSA directs trading partners
to coordinate with one another during investigations and dispositions
of products, certain types of trading partners are typically better
suited to handle specific aspects of those statutory requirements; (4)
clarify that FDA will make requests for verification if a trading
partner is in possession or control of a product that the Agency has
determined to be suspect product; (5) clarify FDA's understanding of
what ``electronic quarantine'' means; (6) clarify when samples of
illegitimate product should be retained; (7) clarify FDA's expectations
related to the requirements for responding to requests for verification
from authorized trading partners; (8) inform trading partners of the
information that should be communicated among trading partners when
determining whether a suspect product is illegitimate; and (9) inform
trading partners of the information that should be included when
responding to requests for verification from FDA and other trading
partners (where applicable), and verifying saleable returned product.
In addition, editorial changes were made to improve clarity.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent 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 of 1995
This draft guidance includes information collection provisions that
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520)
(PRA). FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent substantive or material modifications to
those previously approved collections of information found in FDA
regulations or guidance.
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> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: March 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05018 Filed 3-9-22; 8:45 am]
BILLING CODE 4164-01-P
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