Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry May 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
Under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-18 1), trading partners in the pharmaceutical distribution supply chain must perform specific tasks and comply with requirements to enable the traceability and security of certain prescription drugs as they are distributed in the United States. Section 582(a)(3) gives FDA the authority to grant waivers, exceptions, and exemptions from these requirements in certain situations. This guidance describes recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from the requirements of section 582 of the FD&C Act, and describes how FDA intends to review and decide such requests and determine FDA-initiated exceptions and exemptions. Additionally, this guidance describes how FDA intends to biennially review and renew waivers, exceptions, and exemptions
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1434.