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# DSCSA Waiver, Exception, Exemption Guidance
- URL: https://www.fdaweb.com/dscsa-waiver-exception-exemption-guidance/
- Published: 2023-08-03T12:00:00.000Z
- Updated: 2026-09-14T18:48:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155020

FDA has published a guidance, *Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act*, describing how an authorized trading partner or other stakeholder should request a waiver, exception, or exemption from the Drug Supply Chain Security Act (DSCSA). The [document](https://www.fda.gov/media/113342/download?ref=fdaweb.com) also describes the factors FDA will consider when evaluating such requests and when determining FDA-initiated exceptions and exemptions.

The guidance further describes the process FDA says it intends to follow every two years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable.

The document finalizes a 05/2018 draft guidance and updates the policy articulated in that draft.

It contains an Introduction; Background; Process for Submitting Waiver, Exception, or Exemption Requests to FDA; Process for Reviewing and Determining Waiver, Exception, or Exemption Requests; Process for FDA-Initiated Exceptions and Exemptions; Review and Renewal of Waiver, Exception, and Exemption Requests; and an Appendix.