Notice2021-11735
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
Primary source
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Published
June 4, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act." The draft guidance is intended to help industry better understand the definitions of "suspect" and "illegitimate" product as defined in the Drug Supply Chain Security Act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 The draft guidance lays out FDA's current understanding of the following key terms used to define "suspect" and "illegitimate" product: "Counterfeit," "diverted," "stolen,"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." This revised draft guidance clarifies certain points of the draft guidance for industry "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" issued in March 2018 (March 2018 draft guidance), including FDA's current understanding of the term "stolen."
Full Text
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<title>Federal Register, Volume 86 Issue 106 (Friday, June 4, 2021)</title>
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[Federal Register Volume 86, Number 106 (Friday, June 4, 2021)]
[Notices]
[Pages 30056-30058]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-11735]
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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;
Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled
``Definitions of Suspect Product and Illegitimate Product for
Verification Obligations Under the Drug Supply Chain Security Act.''
The draft 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 draft 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.'' This revised draft guidance clarifies certain points of
the draft guidance for industry ``Definitions of Suspect Product and
Illegitimate Product for Verification Obligations Under the Drug Supply
Chain Security Act'' issued in March 2018 (March 2018
[[Page 30057]]
draft guidance), including FDA's current understanding of the term
``stolen.''
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 3, 2021.
ADDRESSES: You may submit comments on any guidance 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; 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)).
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. 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#5f3b2d2a382b2d3e3c343e313b2b2d3e3c3a1f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="ceaabcbba9babcafada5afa0aababcafadab8ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft 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
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 draft 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 draft 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.'' In response to comments received from
stakeholders, this draft guidance revises the March 2018 draft
guidance. Most significantly, this revised draft guidance: (1) Provides
for FDA's current understanding of the term ``stolen''; (2) identifies
certain scenarios that are unlikely to result in diverted product; (3)
revises the definition of ``unfit for distribution'' by tying it more
closely to the language in the DSCSA and referencing ``serious adverse
health consequences or death to humans''; and (4) revises the
definition of ``fraudulent transaction'' to apply to situations where
information has been ``knowingly'' falsified.
This 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 ``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.
[[Page 30058]]
You can use an alternative approach if it satisfies the requirements of
the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft 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>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11735 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P
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