The Drug Quality and Security Act, signed into law on November 27, 2013, creates a new section 503B in the FDCA. Under section 503B, a compounder can become 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 section 503B.
Drugs compounded by an outsourcing facility can qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not from current good manufacturing practice (CGMP) requirements.
- must comply with CGMP requirements;
- will be inspected by FDA according to a risk-based schedule; and
- must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
Entities Considering Whether to Register as an Outsourcing Facility
- Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 71KB)
- Questions and Answers Related to Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Registered Outsourcing Facilities