[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Pages 60951-60953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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finalizes the revised draft guidance of the same title, ``DSCSA 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:
     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-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 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: Lysette Deshields, 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 ``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 https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies).
    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 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 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