FDA issues draft guidance on drug compounding, repackaging

The Food and Drug Administration today released for public comment four draft guidance documents on drug compounding and repackaging for outsourcing facilities, state-licensed pharmacies and federal facilities. Two documents describe the FDA’s current thinking regarding whether an entity should register as an outsourcing facility, a regulatory category created by the Drug Quality and Security Act of 2013; and adverse event reporting for outsourcing facilities. The other documents describe the conditions under which FDA will not take action for violations related to facilities that repackage certain drug products, and facilities that mix, dilute or repackage specific biological products or prepare prescription sets of allergenic extracts outside of an approved biological license. FDA will accept comments on the draft guidance for 90 days. The agency also issued for comment for 120 days a draft memorandum of understanding for states regarding interstate distribution of “inordinate amounts” of compounded drugs by licensed pharmacists or physicians who compound drugs exempt from certain provisions of FDA law.