Human Drug Compounding Registration And Product Reporting Procedures
The Drug Quality and Security Act (DQSA) adds new section 503B to the Federal Food, Drug & Cosmetic Act (FDCA). Under section 503B, a compounder can register as an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of this section. Registered outsourcing facilities must submit information about their products to the FDA at the time of registration and twice each year after initially registering.
FDA has published draft guidances on registering and reporting product information for those entities that intend to register as outsourcing facilities. Further information can be found at the links below.
When registering using the electronic system, please note the FDA has created a new category of business operation called “Human Drug Compounding Outsourcing Facility.” Facilities registering pursuant to 503B should use this operation.
- The Drug Quality and Security Act: Human Drug Compounding Outsourcing Facility
- Guidance for Industry: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB) (Draft Guidance)
- Guidance for Industry: Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB) (Draft Guidance)
- For questions related to Registration and Listing: eDRLS@fda.hhs.gov
- For questions related to compounding practices: firstname.lastname@example.org