This list reflects those drugs that have been withdrawn or removed from the market because the drugs or components of such drugs have been found to be unsafe or not effective. See 21 C.F.R. § 216.24. FDA is at it again with another proposed rule that would further amend this list.

This list reflects those drugs that have been withdrawn or removed from the market because the drugs or components of such drugs have been found to be unsafe or not effective. See 21 C.F.R. § 216.24. FDA originally published its withdrawn or removed list back in 1999.

FDA will also seek the Committee’s input on proposed revisions to the list of drugs that cannot be compounded because they have been withdrawn or removed from the market. A list of those drugs is currently codified at 21 CFR 216.24, and FDA is considering whether to add four more drugs to the list: aprotinin, ondansetron hydrochloride, bromocriptine mesylate, and acetaminophen. The list may specify that a drug cannot be compounded in any form, or just a particular formulation, indication, dosage form, or route of administration.