[Federal Register Volume 87, Number 47 (Thursday, March 10, 2022)]
[Notices]
[Pages 13738-13739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05018]


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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Certain Prescription Drugs; Draft Guidance for Industry; Availability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the availability of a revised draft guidance entitled ``Verification 
Systems Under the Drug Supply Chain Security Act for Certain 
Prescription Drugs.'' This revised draft guidance addresses the 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 Specifically, this revised draft 
guidance covers the statutory verification system requirements that 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 The revised draft guidance also addresses the 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 Finally, the revised draft guidance addresses 
the statutory requirement for responding to requests for verification 
and processing saleable returns.

DATES: The announcement of the guidance is published in the Federal 
Register on March 10, 2022.

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; Draft 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)).

[[Page 13739]]

    Submit written requests for single copies of the draft 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. Send one 
self-addressed adhesive label to assist the office in processing your 
requests. The guidance may also be obtained by mail by calling CDER at 
at 1-800-835-4709 or 240-402-8010. 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].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft 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 revised draft 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 revised 
draft 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.
    In the Federal Register of October 25, 2018 (83 FR 53880), FDA 
announced the availability of a draft guidance entitled ``Verification 
Systems Under the Drug Supply Chain Security Act for Certain 
Prescription Drugs'' dated October 24, 2018. FDA received several 
comments on the draft guidance, which have been taken into 
consideration. In response to comments received from stakeholders, this 
draft guidance revises the October 2018 draft guidance to: (1) Provide 
FDA's interpretation of what ``possession or control'' means as used 
throughout the DSCSA; (2) explain that the guidance uses the term 
verification in referring to both the broad set of requirements set 
forth in paragraphs (b)(4), (c)(4), (d)(4), and (e)(4) of section 582 
of the FD&C Act in addition to using the term with the meaning defined 
in section 581(28) of the FD&C Act, where appropriate to the context; 
(3) recognize that, in cases where the DSCSA directs trading partners 
to coordinate with one another during investigations and dispositions 
of products, certain types of trading partners are typically better 
suited to handle specific aspects of those statutory requirements; (4) 
clarify that FDA will make requests for verification if a trading 
partner is in possession or control of a product that the Agency has 
determined to be suspect product; (5) clarify FDA's understanding of 
what ``electronic quarantine'' means; (6) clarify when samples of 
illegitimate product should be retained; (7) clarify FDA's expectations 
related to the requirements for responding to requests for verification 
from authorized trading partners; (8) inform trading partners of the 
information that should be communicated among trading partners when 
determining whether a suspect product is illegitimate; and (9) inform 
trading partners of the information that should be included when 
responding to requests for verification from FDA and other trading 
partners (where applicable), and verifying saleable returned product. 
In addition, editorial changes were made to improve clarity.
    This revised draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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 of 1995

    This draft guidance includes information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520) 
(PRA). 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 or https://www.regulations.gov.

    Dated: March 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05018 Filed 3-9-22; 8:45 am]
BILLING CODE 4164-01-P


