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

Résumé

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 This guidance finalizes the draft guidance of the same title issued on May 9, 2018.