Notice2022-01926
Drug Product Tracing: The Effect of Section 585 of the Federal Food, Drug, and Cosmetic Act-Questions and Answers; Guidance for Industry; Availability
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Published
February 4, 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 final guidance for industry entitled "Drug Product Tracing: The Effect of Section 585 of the FD&C Act--Questions and Answers." FDA is issuing this guidance to assist industry and State and local governments in understanding the effects of the uniform national policy set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that was added by the Drug Supply Chain Security Act, which was enacted on November 27, 2013. This guidance is intended to help industry and States understand the law as it is currently in effect and clarify its effect on State product tracing. This guidance finalizes the draft guidance entitled "The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers" issued on October 8, 2014.
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6572-6574]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01926]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1411]
Drug Product Tracing: The Effect of Section 585 of the Federal
Food, Drug, and Cosmetic Act--Questions and Answers; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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
Product Tracing: The Effect of Section 585 of the FD&C Act--Questions
and Answers.'' FDA is issuing this guidance to assist industry and
State and local governments in understanding the effects of the uniform
national policy set forth in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) that was added by the Drug Supply Chain Security Act, which
was enacted on November 27, 2013. This guidance is intended to help
industry and States understand the law as it is currently in effect and
clarify its effect on State product tracing. This guidance finalizes
the draft guidance entitled ``The Effect of Uniform National Policy on
Drug Product Tracing and Wholesale Drug Distributor and Third-Party
Logistics Provider Standards: Questions and Answers'' issued on October
8, 2014.
DATES: The announcement of the guidance is published in the Federal
Register on February 4, 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
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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-1411 for ``Drug Product Tracing: The Effect of Section 585
of the FD&C Act--Questions and Answers.'' 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 the 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: Aaron Weisbuch, 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#0e6a7c7b697a7c6f6d656f606a7a7c6f6d6b4e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="32564047554640535159535c564640535157725456531c5a5a411c555d44">[email protected]</span></a>; or Stephen Ripley, 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 final guidance for industry
entitled ``Drug Product Tracing: The Effect of 585 of the FD&C Act--
Questions and Answers.'' Title II of the Drug Quality and Security Act
(Pub. L. 113-54), which is also referred to as the Drug Supply Chain
Security Act (DSCSA), enacted on November 27, 2013, established a
Federal system for tracing prescription drug products through the
pharmaceutical distribution supply chain and requires trading partners
to provide, receive, and maintain certain product and distribution
information. The DSCSA also requires FDA to establish Federal standards
for licensing of wholesale drug distributors and third-party logistics
providers (3PLs); the Agency is publishing a proposed rule with respect
to those standards concurrently with this final guidance. Section 585
of the FD&C Act (21 U.S.C. 360eee-4) sets forth a uniform national
policy preempting States from establishing or continuing in effect
certain standards and requirements. The guidance is intended to (1)
help industry and States understand the law as it is currently in
effect and (2) clarify the effect of section 585(a) on State product
tracing.
This guidance finalizes the draft guidance entitled ``The Effect of
Uniform National Policy on Drug Product Tracing and Wholesale Drug
Distributor and Third-Party Logistics Provider Standards: Questions and
Answers'' issued on October 8, 2014 (79 FR 60853). The draft guidance
covered section 585(a) and (b) of the FD&C Act. This guidance does not
cover the effect of section 585(b) of the FD&C Act, given that section
585(b) is addressed in the preamble to the proposed rule with respect
to the standards for licensing wholesale distributors and 3PLs,
published elsewhere in this issue of the Federal Register. FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include the
removal of the discussion of the effect of 585(b) of the FD&C Act. The
title of the guidance has been updated to reflect this change in
content. 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 ``Drug Product Tracing: The Effect of 585 of
the FD&C Act--Questions and Answers.'' 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 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
https://
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www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-
drugs, <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: January 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01926 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P
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