Draft Guidance on Prohibition of Compounded Drug Wholesaling Released by FDA

Food and Drug Administration (FDA) has released draft guidance that describes how the agency intends to apply the provisions of Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning the prohibition of wholesaling for certain compounded drugs. The guidance, titled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act, aims to ensure that compounding is based on patient need and to reduce the overall risk of patient harm by preserving the integrity of the United States drug approval process and of the US drug supply chain. Outsourcing facilities that produce compounded drugs may qualify for exemptions from certain statutory requirements under Section 503B of the FD&C Act if 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.