Compounding Entities Begin to Register With FDA as Outsourcing Facilities

Fourteen facilities are the first to be registered as Human Drug Compounding Outsourcing Facilities with FDA under the DQSA. FDA has published a list of the firms, including information about FDA actions, inspection dates, and whether firms compound sterile drugs from bulk drug substances. FDA explains that after an entity is registered, the facility is subject to inspection by the agency scheduled according to risk. Depending on the number of outsourcing facility registrations, FDA expects to complete inspections of all newly registered outsourcing facilities within two months of initial registration. FDA emphasizes that outsourcing facilities are not required to be licensed pharmacies, but that all compounding must be by or under the direct supervision of a licensed pharmacist. Such facilities may or may not obtain prescriptions for identified individual patients. Additional information is available in the “Information Concerning Outsourcing Facility Registration" section of the Registered Outsourcing Facilities webpage.