Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability

CourtFood And Drug Administration
Citation87 FR 13738
Published date10 March 2022
Record Number2022-05018
Federal Register, Volume 87 Issue 47 (Thursday, March 10, 2022)
[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                Certain Prescription Drugs; Draft Guidance for Industry; Availability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                the availability of a revised draft guidance entitled ``Verification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 This revised draft guidance addresses the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 Specifically, this revised draft
                guidance covers the statutory verification system requirements that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 The revised draft guidance also addresses the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
                

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