[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Notices]
[Pages 60217-60218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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guidance finalizes the draft guidance of the same title issued on June 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected]; 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):
     The exchange of transaction information and transaction 
statements in a secure, interoperable, electronic manner.
     Transaction information that includes the product 
identifier at the package level for each package included in the 
transaction.
     Systems and processes for verification of product at the 
package level.
     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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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