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# Wholesaling Prohibition Guidance
- URL: https://www.fdaweb.com/wholesaling-prohibition-guidance/
- Published: 2023-06-27T12:00:00.000Z
- Updated: 2026-09-14T18:41:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154777

FDA has published a draft guidance, *Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act*, describing the agency’s interpretation of, and policies concerning, the prohibition on wholesaling compounded drugs in Section 503B of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/media/169838/download?ref=fdaweb.com) also describes examples of how the agency intends to apply Section 503B’s wholesaling provision.

The guidance includes an Introduction, Background, and Policy about Key Terms, Application of the Wholesaling Prohibition to Examples of Sales and Transfers, and Inspections and Regulatory or Enforcement Action.