FDA Amends List of Drugs that May Not Be Compounded

Oct. 10, 2016

The Food and Drug Administration (FDA) announced that it is amending regulations to revise the list of drugs that have been withdrawn or removed from the market because the drug products or their components have been found to be unsafe or ineffective.

Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the rule adds 24 entries to this list of drug products, modifies the description of one entry on this list, and revises the list's title and introductory language. These revisions are necessary because information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule. See the full list.