Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Industry Government Regulation Legislation, Drug United States United States. Food and Drug Administration United States.
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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 section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as amended by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54). This guidance also describes the factors the Food and Drug Administration (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 two 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 This guidance finalizes the draft guidance for industry Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, issued in May 2018 as required by section 582(a)(3) of the FD&C Act. The revisions described in this document update the policy articulated in the May 2018 draft guidance. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (11 pages))
- NLM Unique ID:
- 9918663779706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918663779706676