Tuesday, June 27, 2023
FDA Announces Draft Guidance on Prohibitions of Compounded Drug Wholesaling
FDA Announces Draft Guidance on Prohibitions of Compounded Drug Wholesaling
Today, FDA announced the availability of a draft guidance, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act, that, if finalized, will describe how FDA intends to apply section 503B’s wholesaling provision to outsourcing facilities that compound drugs. The statutory prohibition on wholesaling helps to ensure that compounding is based on patient need, which, in turn, reduces the overall risk of patient harm and helps to preserve the integrity of the U.S. drug approval process and of the U.S. drug supply chain.One condition for an outsourcing facility to compound a drug under section 503B is that the drug will not be sold or transferred by an entity other than the outsourcing facility that compounded the drug. However, this wholesaling provision does not prohibit administration of a drug in a health care setting or dispensing a drug to a patient with a valid prescription. This prohibition preserves important distinctions between outsourcing facilities, which are intended to compound drugs for patients whose medical needs cannot be met by approved drugs, from conventional manufacturers, which generally engage in mass manufacturing of FDA-approved drug products.
Compounded drugs are not FDA-approved and have not been reviewed by the agency for safety, effectiveness, or quality before they are marketed.
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