FDA announces outsourcing registration guide and bi-annual list of registered outsourcing facility drug products

UCM577334.pdf

FDA announces outsourcing registration guide and bi-annual list of registered outsourcing facility drug products

Today the Food and Drug administration posted two new resources for pharmacists and health care providers: The Center for Drug Evaluation and Research Outsourcing Facility Information document is intended to assist outsourcing facilities in locating provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA policy and procedures that are relevant to their operations, and to assist compounders in deciding whether to register with FDA as outsourcing facilities. The bi-annual outsourcing facility product report is available on FDA’s Outsourcing Facilitiesweb page. This document lists drug products that outsourcing facilities reported were produced during prior reporting periods, beginning with the December 2016 to May 2017 period.  The FDA announced these new resources at the 2017 Intergovernmental Working Meeting on Pharmacy Compounding. Anna Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis, provided opening remarks at the meeting.   Also read FDA Commissioner Scott Gottlieb’s statement on FDA’s efforts to encourage compounding of better quality drugs.  FDA’s website has additional information on Human Drug Compounding.