Today, the U.S. Food and Drug Administration issued a final rule amending FDA’s list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that allow the marketing of unapproved compounded drugs.
Drug products on the list may not be compounded because the drug products have been withdrawn or removed from the market for safety or effectiveness reasons. The list appears in the Code of Federal Regulations at Title 21, section 216.24.
The final rule:
- Adds 24 types of drugs to the withdrawn or removed list.
- Modifies the withdrawn or removed list to allow one type of drug product to be compounded under certain circumstances.
- Clarifies that the withdrawn or removed list applies to sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
In addition, FDA published a discussion in the Federal Register that clarifies the procedure FDA intends to use to amend the withdrawn or removed list.
FDA’s website has additional information on compounding.