Notice2023-18831
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry; Availability
Primary source
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Published
August 31, 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 "Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act." This guidance clarifies the enhanced drug distribution security requirements listed in the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, this guidance outlines and makes recommendations on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary. This guidance finalizes the draft guidance of the same title issued on June 4, 2021.
Full Text
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<title>Federal Register, Volume 88 Issue 168 (Thursday, August 31, 2023)</title>
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[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60217-60218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-18831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-2024]
Enhanced Drug Distribution Security at the Package Level 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 ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act.'' This guidance clarifies the enhanced drug
distribution security requirements listed in the Federal Food, Drug,
and Cosmetic Act (FD&C Act). In addition, this guidance outlines and
makes recommendations on the system attributes necessary to enable
secure tracing of product at the package level, including allowing for
the use of verification, inference, and aggregation, as necessary. This
guidance finalizes the draft guidance of the same title issued on June
4, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on August 31, 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-2020-D-2024 for ``Enhanced Drug Distribution Security at the
Package Level Under the Drug Supply Chain Security Act.'' 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: Abha Kundi, 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#a7c3d5d2c0d3d5c6c4ccc6c9c3d3d5c6c4c2e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="a7c3d5d2c0d3d5c6c4ccc6c9c3d3d5c6c4c2e7c1c3c689cfcfd489c0c8d1">[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 ``Enhanced Drug Distribution Security at the Package Level
Under the Drug Supply Chain Security Act.'' The Drug Supply Chain
Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law
on November 27, 2013.
The DSCSA outlines critical steps to achieve electronic
pharmaceutical supply chain interoperability by November 27, 2023, that
will enhance
[[Page 60218]]
the identification and tracing of certain prescription drugs as they
are distributed within the United States. Section 202 of the DSCSA
added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which
established product tracing, product identifier, authorized trading
partner, and verification requirements for manufacturers, repackagers,
wholesale distributors, and dispensers to facilitate the tracing of
products through the pharmaceutical distribution supply chain. Section
582 of the FD&C Act also imposed requirements for enhanced drug
distribution security that go into effect on November 27, 2023.
Trading partners, along with Federal and State authorities, have an
important role in ensuring the quality of prescription drugs and
protecting the integrity of the pharmaceutical distribution supply
chain. The DSCSA requirements, which have been phased in since 2013,
improve supply chain security activities by trading partners involved
in prescription drug manufacturing, repackaging, wholesale
distribution, warehousing or related logistical activities, and
dispensing. The gradual implementation of the DSCSA requirements for
product tracing, product identification, authorized trading partners,
and verification facilitates the development of electronic
interoperability to enhance the security of the pharmaceutical
distribution supply chain.
Section 582(g)(1) of the FD&C Act sets forth the requirements for
enhanced drug distribution security as of November 27, 2023, including
(as described in that provision and generally summarized here):
<bullet> The exchange of transaction information and transaction
statements in a secure, interoperable, electronic manner.
<bullet> Transaction information that includes the product
identifier at the package level for each package included in the
transaction.
<bullet> Systems and processes for verification of product at the
package level.
<bullet> Systems and processes needed to promptly respond to
requests from FDA (or other appropriate Federal or State officials) for
product transaction information in the event of a recall or to
investigate suspect and illegitimate products.
This guidance clarifies the enhanced drug distribution security
requirements and pursuant to section 582(h)(3) of the FD&C Act
describes recommendations for system attributes necessary for enhanced
product tracing and enhanced verification, including when the use of
aggregation and inference may be appropriate.
This guidance finalizes the draft guidance entitled ``Enhanced Drug
Distribution Security at the Package Level Under the Drug Supply Chain
Security Act'' issued on June 4, 2021 (86 FR 30053). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft to the final guidance include removal of the
term ``enhanced system'' when referring to the requirements in section
582(g) of the FD&C Act to avoid confusion and clarification of
recommendations addressing (1) reconciliation of transaction
information, (2) aggregation and inference, and (3) verification of
saleable returns, including a brief discussion of the sunset provisions
of section 582(k) of the FD&C Act. Changes also include clarification
of requirements for provision of certain information in response to
requests stemming from investigation of suspect or 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 ``Enhanced Drug Distribution Security at the
Package Level 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 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
<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 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-18831 Filed 8-30-23; 8:45 am]
BILLING CODE 4164-01-P
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