FDA Recommends Sterile Compounding Drug Purchasers Work with Registered Outsourcing Facilities
Yesterday, FDA Commissioner Margaret Hamburg sent letters recommending "purchasers to consider requiring compounders from which they purchase compounded sterile drugs to meet the medical needs of patients that cannot be met by FDA-approved products to register with the Food and Drug Administration (FDA) as outsourcing facilities." Dr. Hamburg also sent letters to State Governors, State Boards of Pharmacies, and State Boards of Health asking them to consider how they could encourage compounding pharmacies located outside of their States that ship compounded sterile drugs into their States to register with FDA as outsourcing facilities under Section 503B of the Federal, Food Drug and Cosmetic Act.
FDA also published on its web site a list of firms currently registered as Human Drug Compounding Outsourcing Facilities, as well as additional information about the firms and what it means to be a registered outsourcing facility. FDA will update the list of firms registered as outsourcing facilities weekly. Click here to view FDA's Outsourcing Facility information.
Currently, the following are listed on FDA's website as registered outsourcing facilities:
Allergy Laboratories, Inc.; Banner Health; Cantrell Drug Company; Kings Park Slope, Inc.; KRS Global Biotechnology, Inc.; Marlborough Hospital; Medi-Fare Drug & Home Health Center, Inc.; PharMedium Services, LLC; Region Care, Inc.; SCA Pharmaceuticals; and, US Compounding, Inc.
IACP will continue to bring you updates on the Outsourcing Facility Registration process.