Notice2023-19182
Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 6, 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 "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs." This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance finalizes the revised draft guidance of the same title, "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs," issued in July 2022, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Full Text
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<title>Federal Register, Volume 88 Issue 171 (Wednesday, September 6, 2023)</title>
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[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60951-60953]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19182]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1981]
Drug Supply Chain Security Act Standards for the Interoperable
Exchange of Information for Tracing of Certain Human, Finished,
Prescription Drugs; 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 ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs.'' This guidance identifies
the standards necessary to facilitate adoption of secure,
interoperable, electronic data exchange among the pharmaceutical
distribution supply chain, and clarifies the trading partners,
products, and transactions subject to such standards. This guidance
finalizes the revised draft guidance of the same title, ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs,'' issued in July 2022, as
required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: The announcement of the guidance is published in the Federal
Register on September 6, 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-2014-D-1981 for ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain
[[Page 60952]]
Human, Finished, Prescription Drugs.'' 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 to 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: Lysette Deshields, 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#2145535446555340424a404f455553404244614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="7115030416050310121a101f150503101214311715105f1919025f161e07">[email protected]</span></a>; or Anne Taylor, 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 ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription
Drugs.'' The FD&C Act, as amended by the Drug Supply Chain Security Act
(DSCSA), outlines requirements for enhanced drug distribution security,
which include the steps to achieve interoperable, electronic tracing of
products at the package level. Section 582(g)(1) of the FD&C Act (21
U.S.C. 360eee-1(g)(1)) sets forth enhanced drug distribution security
requirements for trading partners, including adherence to standards
established by FDA for the exchange of transaction information and
transaction statements in a secure, interoperable, electronic manner
and the verification of product at the package level. Section 582(g)(1)
of the FD&C Act states that these enhanced drug distribution security
requirements go into effect on November 27, 2023. Additionally, section
582(h)(4)(A) of the FD&C Act specifies that FDA issue a guidance to
identify and make recommendations with respect to the standards
necessary for adoption in order to support the secure, interoperable,
electronic data exchange among the pharmaceutical distribution supply
chain that comply with a form and format developed by a widely
recognized international standards development organization.
In this guidance, FDA considered the standards established pursuant
to sections 505D of the FD&C Act (21 U.S.C. 355e). FDA also considered
the standards established pursuant to section 582(a)(2) of the FD&C Act
and described in the July 2022 revised draft guidance entitled ``DSCSA
Standards for the Interoperable Exchange of Information for Tracing of
Certain Human, Finished, Prescription Drugs.'' The pilot projects
conducted per section 582(j) of the FD&C Act also informed this
guidance.
In November 2014, FDA issued a draft guidance for industry,
entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information.'' In July 2022, FDA issued
a revised draft guidance, entitled ``DSCSA Standards for the
Interoperable Exchange of Information for Tracing of Certain Human,
Finished, Prescription Drugs'' (87 FR 40258), that updated the policies
articulated in the 2014 draft guidance. This guidance finalizes the
July 2022 revised draft guidance. FDA considered comments received on
the revised draft guidance as the guidance was finalized. Changes were
made to the guidance to improve clarity. This guidance finalizes the
policy articulated in the July 2022 revised draft guidance to reflect
the enhanced drug distribution security requirements in section
582(g)(1) of the FD&C Act that will go into effect on November 27,
2023, including that only electronic methods of product tracing will be
permitted and verification of product at the package level will be
required, unless a waiver, exception, or exemption applies. This
guidance is intended to also facilitate the creation of a uniform
methodology for product tracing while ensuring the protection of
confidential commercial information and trade secrets. FDA also
published other guidances describing recommendations for enhanced drug
distribution security, including the attributes necessary for enhanced
product tracing and verification, which should be read in conjunction
with this guidance (see FDA's Drug Supply Chain Security Law and
Policies web page at <a href="https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies">https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies</a>).
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 ``DSCSA Standards for the Interoperable
Exchange of Information for Tracing of Certain Human, Finished,
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.
[[Page 60953]]
II. Paperwork Reduction Act of 1995
This guidance includes information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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>, <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: August 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19182 Filed 9-5-23; 8:45 am]
BILLING CODE 4164-01-P
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