
[Federal Register Volume 88, Number 234 (Thursday, December 7, 2023)]
[Notices]
[Pages 85295-85296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3462]


Verification Systems Under the Drug Supply Chain Security Act for 
Certain 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 
``Verification Systems Under the Drug Supply Chain Security Act for 
Certain Prescription Drugs.'' The guidance addresses the verification 
systems that manufacturers, repackagers, wholesale distributors, and 
dispensers must have in place to comply with the Federal Food, Drug, 
and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain 
Security Act (DSCSA). Specifically, the guidance covers the statutory 
verification systems requirements that include the quarantine and 
investigation of a product determined to be suspect and the quarantine 
and disposition of a product determined to be illegitimate. The 
guidance also addresses the statutory requirement for notification to 
the Agency of a product that has been cleared by a manufacturer, 
repackager, wholesale distributor, or dispenser (also referred to as 
``trading partners'') after a suspect product investigation because it 
is determined that the product is not an illegitimate product. Finally, 
the guidance addresses the statutory requirement for responding to 
requests for verification and processing saleable returns. The guidance 
finalizes the revised draft guidance ``Verification Systems Under the 
Drug Supply Chain Security Act for Certain Prescription Drugs,'' issued 
on March 10, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on December 7, 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-2018-D-3462 for ``Verification Systems Under the Drug Supply Chain 
Security Act for Certain Prescription Drugs; Guidance for Industry; 
Availability.'' 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 Office of 
Communication, Outreach and Development, Center for

[[Page 85296]]

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: Sarah Venti, 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, 
[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 ``Verification Systems Under the Drug Supply Chain Security 
Act for Certain Prescription Drugs.'' The DSCSA (title II of Pub. L. 
113-54) was signed into law on November 27, 2013. Section 202 of the 
DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which 
established the requirement that trading partners have systems in place 
to enable them to comply with certain verification obligations. This 
guidance provides recommendations for robust verification systems for 
the determination, quarantine, and investigation of suspect products, 
as well as the quarantine, notification, and disposition of 
illegitimate products. This guidance also addresses the manner in which 
FDA recommends that trading partners submit cleared product 
notifications (i.e., notifications that a suspect product is not an 
illegitimate product), the statutory requirements for responding to 
requests for verification, and the statutory requirements for 
processing saleable returns.
    FDA initially published the draft guidance ``Verification Systems 
Under the Drug Supply Chain Security Act for Certain Prescription 
Drugs'' on October 25, 2018 (83 FR 53880). Comments were received on 
the initial draft guidance and the Agency made revisions to the draft. 
This guidance finalizes the revised draft guidance entitled 
``Verification Systems Under the Drug Supply Chain Security Act for 
Certain Prescription Drugs,'' issued on March 10, 2022 (87 FR 13738). 
FDA considered comments received on the revised draft guidance in 
finalizing this guidance. Changes from the revised draft to the final 
guidance include: (1) clarifying that dispensers need not provide 
transaction information for saleable return product; (2) clarifying 
that ``verification'' as defined in section 581 of the FD&C Act (21 
U.S.C. 360eee) involves confirming that the product identifier affixed 
or imprinted upon a package or homogeneous case corresponds to the 
Standardized Numerical Identifier or lot number and expiration date 
assigned to the product by the manufacturer or repackager by more 
closely mirroring the statutory language; (3) further clarifying when 
the discussion is about the verification systems requirements in 
section 582 of the FD&C Act and when it is about the requirement to 
verify the product identifier; (4) clarifying FDA's understanding about 
the statutory requirement that manufacturers and repackagers respond to 
requests for verification within 24 hours or within other such 
reasonable time as determined by the Secretary of Health and Human 
Services; (5) clarifying that when a trading partner does not receive a 
timely response to a verification request, the product that is the 
subject of the request need not automatically be classified as suspect; 
and (6) clarifying that certain system attributes are suggested as best 
practices even though they are not specifically required under the 
DSCSA. 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 ``Verification Systems Under the Drug Supply 
Chain Security Act for Certain 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.

II. Paperwork Reduction Act

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
pertaining to implementation of the Drug Supply Chain Security Act are 
approved in OMB control no. 0910-0806.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, 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: December 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26846 Filed 12-6-23; 8:45 am]
BILLING CODE 4164-01-P


