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# Supply Chain Waiver Guidance
- URL: https://www.fdaweb.com/supply-chain-waiver-guidance/
- Published: 2018-05-08T12:00:00.000Z
- Updated: 2026-09-15T00:03:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141381

FDA has issued a draft guidance, *Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act*, with agency recommendations for how trading partners and stakeholders should request a waiver, exception, or exemption from requirements that drug distribution supply chain trading partners must perform specific tasks and comply with requirements to enable the traceability and security of certain prescription drugs. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM606876.pdf?ref=fdaweb.com) also describes how the agency intends to review and decide such requests and determine FDA-initiated exceptions and exemptions. And it describes how FDA intends to biennially review and renew waivers, exceptions, and exemptions.