U.S. Food and Drug Administration (FDA) Issues Draft Guidance Documents on Compounding

August 11, 2016

• The FDA issued 2 draft guidance documents describing how they plan to implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The draft guidance documents apply to pharmacies, physicians, federal facilities, and outsourcing facilities. Public comments are due by October 11, 2016. The draft guidance documents are:
  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act 
  • Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

• The FDA also issued a draft guidance on Insanitary Conditions at Compounding Facilities. This guidance aims to assist compounding facilities in identifying insanitary conditions that can result in patient harm, so that they can implement appropriate corrective actions. The guide will also assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. Public comments are due by October 3, 2016.

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