FDAnews Drug Daily Bulletin

FDA Adds 24 Entries to List of Drugs That Are Prohibited in Compounding

Oct. 17, 2016

The FDA is revising the list of drug products that have been banned or removed from the market for safety or effectiveness reasons and so cannot be used in compounding.

The drugs on this list may not be compounded under exemptions provided by sections 503A and 503B of the Food, Drug, and Cosmetic Act. The revisions are necessary as new information has come to the agency’s attention. The agency is finalizing in part the proposed amendments published in the Federal Register in July 2014.

The new amendment adds 24 entries to the list of drugs and will modify the description of one drug product entry already on this list – bromfenac sodium – to allow an exception when the product is compounded under certain circumstances, as in the proposed rule.

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