Notice2021-11732
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability
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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 final guidance for industry entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification." The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders in order to clarify certain points and finalizes the remaining draft portion of the final guidance for industry entitled "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification," issued in December 2016.
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 30054-30056]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-11732]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Drug Supply Chain Security Act Implementation: Identification of
Suspect Product and Notification; 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 ``Drug
Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification.'' The guidance addresses provisions in the
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug
Supply Chain Security Act (DSCSA). The guidance is intended to aid
certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
specific scenarios that could significantly increase the risk of a
suspect product entering the pharmaceutical distribution supply chain.
The guidance also describes how trading partners should notify FDA of
illegitimate product and sets forth a process for terminating
notifications of illegitimate product in consultation with FDA. In
addition, this guidance describes when manufacturers should notify FDA
of a high risk that a product is illegitimate. This guidance responds
to comments from stakeholders in order to clarify certain points and
finalizes the remaining draft portion of the final guidance for
industry entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification,'' issued in
December 2016.
DATES: The announcement of the guidance is published in the Federal
Register on June 4, 2021.
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
[[Page 30055]]
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-2014-D-0609 for ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification; 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#096d7b7c6e7d7b686a6268676d7d7b686a6c496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="492d3b3c2e3d3b282a2228272d3d3b282a2c092f2d286721213a672e263f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification.'' The guidance
addresses provisions in the FD&C Act, as amended by the DSCSA (Pub. L.
113-54). Section 202 of the DSCSA adds section 582(h)(2) to the FD&C
Act (21 U.S.C. 360eee-1(h)(2)), which requires FDA to issue guidance to
aid certain trading partners (manufacturers, repackagers, wholesale
distributors, and dispensers) in identifying a suspect product and
terminating notifications. The guidance identifies specific scenarios
that could significantly increase the risk of a suspect product
entering the pharmaceutical distribution supply chain and provides
recommendations on how trading partners can identify such product and
determine whether the product is a suspect product as soon as
practicable.
Beginning January 1, 2015, section 582 of the FD&C Act required
trading partners, upon determining that a product in their possession
or control is illegitimate, to notify: (1) FDA and (2) all immediate
trading partners that they have reason to believe may have received the
illegitimate product, not later than 24 hours after making the
determination. Manufacturers are additionally required under section
582(b)(4)(B)(ii)(II) of the FD&C Act to notify FDA and any immediate
trading partners that the manufacturer has reason to believe may
possess a product manufactured by (or purported to be manufactured by)
the manufacturer, not later than 24 hours after the manufacturer
determines or is notified by FDA or a trading partner that there is a
high risk that a product is illegitimate. The guidance also addresses
how trading partners should notify FDA using Form FDA 3911. In
addition, in accordance with section 582(h)(2) of the FD&C Act, the
guidance sets forth the process by which trading partners must
terminate the notifications using Form FDA 3911, in consultation with
FDA, regarding illegitimate product and, for a manufacturer, a product
with a high risk of illegitimacy, under section 582(b)(4)(B),
(c)(4)(B), (d)(4)(B), and (e)(4)(B) of the FD&C Act.
This guidance finalizes the remaining draft portion of the guidance
for industry entitled ``Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification,'' issued in
December 2016. In particular, this guidance finalizes section III.C,
which was issued for comment purposes in the December 2016 guidance.
This guidance will now be final in its entirety and replaces the
December 2016 guidance.
In Federal Register of June 11, 2014 (79 FR 33564), FDA announced
the availability of a draft guidance entitled ``Drug Supply Chain
Security Act Implementation: Identification of Suspect Product and
Notification.'' In response to comments received on that guidance, in
the Federal Register of December 9, 2016 (81 FR 89112) FDA announced
the availability of a guidance
[[Page 30056]]
of the same title. This guidance was published as a final guidance for
industry with the exception of Section C entitled ``For Manufacturers:
High Risk of Illegitimacy Notifications''. This new section was
published as a draft guidance for industry and was added in response to
comments and questions received about the 2014 guidance. In addition,
based on comments on the 2014 guidance, Form FDA 3911, and the
instructions for completing the form, were slightly revised.
FDA received comments on the 2016 guidance from various
stakeholders (e.g., pharmacy groups, wholesale distributor trade
groups). In response to these comments, FDA has made some changes for
clarity to the December 2016 version of the guidance. The changes
include: Clarifying what FDA believes an ``immediate trading partner''
to be; replacing ``suspicious'' with ``questionable'' throughout the
document; deleting the reference to ``pedigree'' in section III.A.1;
clarifying that trading partners should consider whether product has
been subject to a public alert or announcement of drug quality when
considering scenarios that could increase the chances that a suspect
product could enter the supply chain; in section III.B, clarifying that
FDA's recommendations apply only ``as applicable'' to the individual
trading partners; clarifying that trading partners only work with
authorized trading partners in section III.B; and stating that trading
partners should consult with manufacturers when conducting an
investigation of suspect product.
In response to stakeholder comments, FDA has also made some changes
to the newly final section, III.C. These include: Clarifying that while
manufacturers need not notify FDA of suspect product, they must do so
if the circumstances surrounding the suspect product include at least
one of three types of high risk factors; clarifying that manufacturers
can learn of product with a high risk of illegitimacy either through
their own investigation of suspect product, or through information they
receive from a variety of other sources, including from within their
own company, from their trading partners, from the FDA, or from other
domestic and/or foreign regulatory authorities; clarifying that a
manufacturer must make a notification to FDA where it is investigating
the validity of the claim that a product has been stolen or diverted,
and the manufacturer has reason to believe that an immediate trading
partner has the potentially stolen or diverted product in its
possession; and clarifying that while not a requirement, FDA does
suggest that manufacturers inform trading partners of ``specific high
risk[s]''.
Finally, while FDA received a few comments on section IV of this
guidance, which addresses notifications for illegitimate products and
products with a high risk of illegitimacy, along with termination of
those notifications, FDA did not incorporate the feedback from comments
on response times because we feel that a 10-day response time is a
reasonable amount of time for the Agency to review and evaluate such
requests for the termination of notification of illegitimate product.
Similarly, FDA did not add language on disclosure because the
information submitted to FDA using Form FDA 3911 is treated like all
other records obtained by FDA in regard to disclosure. FDA did make
some revisions for clarity however, which include adding a brief
discussion and footnote to FDA's guidance document Definitions of
Suspect Product and Illegitimate Product for Verification Obligations
Under the Drug Supply Chain Security Act. In addition, editorial
changes were made throughout the entire guidance for clarity and
references to section III.C being published for comment purposes only
were removed.
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 ``Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification.''
It does not establish any rights for any person and, with the exception
of section IV.B, 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.
As noted, section IV.B of this guidance, which sets forth the
process by which trading partners must terminate notifications of
illegitimate product and products with a high risk of illegitimacy in
consultation with FDA, has binding effect, where indicated by the use
of the words must, shall, or required. Such binding effect is
authorized by section 582(h)(2)(A) of the FD&C Act, wherein Congress
granted authorization to FDA to implement the process for terminating
notifications of illegitimate product in consultation with FDA through
guidance.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collection
of information in this guidance has been approved under OMB control
number 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm">https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</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. 2021-11732 Filed 6-3-21; 8:45 am]
BILLING CODE 4164-01-P
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