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# Draft Guide on Sec. 582 Waivers, Exceptions
- URL: https://www.fdaweb.com/draft-guide-on-sec-582-waivers-exceptions/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:03:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141398

*Federal Register* notice: FDA has made available a draft guidance entitled “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.” The document describes the process that trading partners and stakeholders should use to request such waivers. It also discusses how the agency intends to review and decide such requests and determine FDA-initiated exceptions and exemptions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-09/pdf/2018-09843.pdf?ref=fdaweb.com).