FDA issues draft guidance on hospital and health system drug compounding

Editor's Note

The Food and Drug Administration (FDA) on April 15 issued draft guidance on “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.”

Hospital pharmacies or standalone pharmacies that are part of a health system provide compounded drugs for administration in the hospital or health system.

Comments and suggestions should be submitted within 90 days of publication in the April 18 Federal Register.

4/15/16] The U.S. Food and Drug Administration (FDA) issued three draft guidance documents related to human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by Title I of the Drug Quality and Security Act (DQSA) in November 2013, that apply to both outsourcing facilities and compounders seeking to operate under section 503A.