2023-16645. Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act.” This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the process the FDA intends to follow once every 2 years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable. This guidance finalizes the draft guidance of the same title issued on May 9, 2018.

DATES:

The announcement of the guidance is published in the Federal Register on August 4, 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–1434 for “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.” 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. 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, [e-mail]; 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 “Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act.” The Food Drug and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA), outlines critical steps to enhance drug distribution security. These steps will ultimately allow tracing of certain human finished prescription drugs in an electronic, interoperable manner as they are distributed within the United States. Section 582 of the FD&C Act (21 U.S.C. 360eee–1), as amended by the DSCSA, applies to manufacturers, repackagers, wholesale distributors, and dispensers (collectively referred to as “trading partners”) who engage in transactions of product, and outlines requirements related to product tracing, verification, product identification, and authorized trading partners.

Section 582(a)(3)(A) of the FD&C Act requires FDA to issue a guidance that: (1) establishes a process by which an authorized manufacturer, repackager, wholesale distributor, or dispenser may request a waiver from any of the requirements set forth in section 582 of the FD&C Act, which the Secretary of HHS (Secretary) may grant if the Secretary determines that such requirements would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act; (2) establishes a process by which the Secretary determines exceptions, and a process through which a manufacturer or repackager may request such an exception, to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with section 582 of the FD&C Act; and (3) establishes a process by which the Secretary may determine other products or transactions that shall be exempt from the requirements of section 582 of the FD&C Act.

Additionally, section 582(a)(3)(B) of the FD&C Act requires the FDA to issue guidance that includes a process describing how the FDA intends to review and renew granted waivers, exceptions, and exemptions.

This guidance finalizes the draft guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” issued on May 9, 2018 (83 FR 21297). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft guidance to the final guidance include: (1) recommending that a requestor submit a request for a waiver, exception, or exemption to FDA electronically; (2) recommending additional information a requestor should provide to FDA in a request for waiver, exception, or exemption; (3) recommending that recipients of a waiver, exception, or exemption notify the Agency of any material change in circumstances that formed the basis for granting the initial request for regulatory relief as soon as possible; (4) recommending that recipients of a waiver, exception, or exemption notify affected entities that a product and/or transaction is subject to a waiver, exception, or exemption; (5) describing how an authorized trading partner and other stakeholder may submit a request to FDA to reconsider the scope of a waiver, exception, or exemption that has been granted; (6) describing how an authorized trading partner and other stakeholder may submit a request to FDA to reconsider and re-evaluate a denied waiver, exception, or exemption request; and (7) recommending that recipients of a waiver, exception, or exemption notify affected entities upon termination of a waiver, exception, or exemption. 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 “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic.” 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

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in “Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act” have been approved under OMB control number 0910–0806.

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: July 31, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.