The FDA has 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certain sections of the Food, Drug, and Cosmetic that provide for marketing of compounded drugs because they have been withdrawn or removed from the market for safety or effectiveness reasons. The proposed rule is open for comment for 75 days.
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.
Please see the statement FDA's website for more information.
The FDA's website has additional information on compounding.