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