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Hospitals' Reliance on Drug Compounding Facilities

Large-scale facilities that compound without a patient-specific prescription are regulated under section 503B of the Food, Drug and Cosmetic Act and referred to as outsourcing facilities. We will determine the extent to which hospitals obtain compounded sterile preparations from compounders, including outsourcing facilities that have registered with the Food and Drug Administration. We will also determine the extent to which compounders that produce compounded sterile preparations without a patient-specific prescription have registered with the Food and Drug Administration.

Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY)
April 2018 Food and Drug Administration Hospitals' Reliance on Drug Compounding Facilities Office of Evaluation and Inspections OEI-01-17-00090 2019