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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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2023-D-0939.