FDA Panel Backs Updates to Bulk Drugs List for Compounding Troy Brown, RN February 25, 2015

The Pharmacy Compounding Advisory Committee of the US Food and Drug Administration (FDA) voted yesterday to add squaric acid dibutyl ester, diphenylcyclopropenone, and cantharidin to its bulk drug substances list but voted not to add piracetam to the list.

The bulk drug substances list is a list of bulk drug substances that may be used to compound drug products according to section 503A of the Federal Food, Drug, and Cosmetic Act, even though they are neither the subject of a United States Pharmacopeia or National Formulary monograph nor components of drugs approved by the FDA. more