Notice2023-05359
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Guidance for Industry; Availability
Primary source
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Published
March 16, 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 "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act." The guidance is intended to help industry better understand the definitions of "suspect" and "illegitimate" product as defined in the Drug Supply Chain Security Act (DSCSA). The guidance lays out FDA's current understanding of the following key terms used to define "suspect" and "illegitimate" product: "counterfeit," "diverted," "stolen," "fraudulent transaction," and "unfit for distribution." The guidance finalizes the draft guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" issued on June 4, 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 51 (Thursday, March 16, 2023)</title>
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[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16270-16271]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05359]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-0338]
Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act;
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
``Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act.''
The guidance is intended to help industry better understand the
definitions of ``suspect'' and ``illegitimate'' product as defined in
the Drug Supply Chain Security Act (DSCSA). The guidance lays out FDA's
current understanding of the following key terms used to define
``suspect'' and ``illegitimate'' product: ``counterfeit,''
``diverted,'' ``stolen,'' ``fraudulent transaction,'' and ``unfit for
distribution.'' The guidance finalizes the draft guidance entitled
``Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act''
issued on June 4, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on March 16, 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-0338 for ``Definitions of Suspect Product and Illegitimate
Product for Verification Obligations Under the Drug Supply Chain
Security Act; Guidance for Industry; Availability.'' Received comments
will be placed in the docket and, except for
[[Page 16271]]
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 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#6703151200131506040c060903131506040227010306490f0f1449000811"><span class="__cf_email__" data-cfemail="7014020517040211131b111e140402111315301614115e1818035e171f06">[email protected]</span></a>; or Diane Maloney, 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 ``Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act.''
This guidance interprets the terms used in the definition of ``suspect
product'' set forth in section 581(21) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and the definition of
``illegitimate product'' set forth in section 581(8) of the FD&C Act to
assist trading partners in meeting verification obligations (including
notification) under section 582(b)(4), (c)(4), (d)(4), and (e)(4) (21
U.S.C. 360eee-1(b)(4), (c)(4), (d)(4), and (e)(4)), respectively.
This guidance is intended to help industry better understand the
definitions of ``suspect'' and ``illegitimate'' product as defined in
section 581 of the FD&C Act. The guidance lays out FDA's current
understanding of the following key terms used to define ``suspect'' and
``illegitimate'' product in section 581 of FD&C Act: ``counterfeit,''
``diverted,'' ``stolen,'' ``fraudulent transaction,'' and ``unfit for
distribution.''
This guidance finalizes the draft guidance entitled ``Definitions
of Suspect Product and Illegitimate Product for Verification
Obligations Under the Drug Supply Chain Security Act'' issued on June
4, 2021 (86 FR 30056). FDA considered comments received on the draft
guidance as the guidance was finalized. Changes from the draft to the
final guidance include: (1) clarifying the definition of ``diverted''
by revising the examples clarifying that there are other scenarios
besides product dispensed to a patient that could result in diverted
product; (2) clarifying FDA's expectations for how trading partners
should handle unaccounted for product that is not immediately
identified as stolen product; (3) expanding on the definition of
``fraudulent transaction'' to clarify how clerical errors or
discrepancies in the product tracing information should be addressed;
and (4) clarifying that the definition of ``unfit for distribution'' in
this guidance applies only to the verification provisions of the DSCSA
and to identifying suspect and illegitimate product. 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 ``Definitions of Suspect Product and
Illegitimate Product for Verification Obligations Under the Drug Supply
Chain Security Act.'' 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
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
<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/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: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05359 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P
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