Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons
[10/17/2016] Today the U.S. Food and Drug Administration proposed a rule that would amend the list of drug products that may not be compounded under certain sections of the Food, Drug, and Cosmetic Act (FD&C Act) that provide for the marketing of compounded drugs.
Drug products on the list have been withdrawn or removed from the market for safety or effectiveness reasons.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The proposed rule, if finalized as written, would add the following types of drugs to the withdrawn or removed list:
- Aprotinin: All drug products containing aprotinin
- Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation
- Ondansetron hydrochloride: All intravenous drug products containing greater than a 16 mg single dose of ondansetron hydrochloride
The FDA’s Federal Register notice includes a discussion of the reasons the agency is proposing these drugs be included on the list.
The public comment period for the proposed rule will be open for 75 days. For information on how to submit comments to the public docket, see the notice in the Federal Register.
FDA’s website has additional information on compounding.