GUIDANCE DOCUMENT
Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act June 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2023-D-0939
- Docket Number:
- FDA-2023-D-0939
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
Under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b), a drug compounded by an outsourcing facility qualifies for exemptions from certain statutory requirements if, among other conditions, the drug “will not be sold or transferred by an entity other than the outsourcing facility that compounded such drug.” However, this provision “does not prohibit administration of a drug in a health care setting or dispensing a drug pursuant to a prescription executed in accordance with section 503(b)(1).” This guidance describes FDA’s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&C Act. This guidance also describes examples of how FDA intends to apply section 503B’s wholesaling provision.