The Drug Quality and Security Act, signed into law on November 27, 2013, created a new section 503B in the Federal Food, Drug, and Cosmetic Act. 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 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;
- are 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.
General information for Outsourcing Facilities and Entities Considering Whether to Register as an Outsourcing Facility
- Information for Outsourcing Facilities
- Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act
- Registered Outsourcing Facilities
- Outsourcing Facility Fees
- Human Drug Compounding Registration and Reporting Procedures
- Questions and Answers: Outsourcing Facility Registration
- Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Questions and Answers Related to Guidance For Entities Considering Whether to Register As Outsourcing Facilities
- Changes that affect compounding as of March 23, 2020
Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. The Outsourcing Facility Product Report searchable database contains information reported to FDA within the last two years (last four reporting periods). This information may be used to identify outsourcing facilities that have produced certain drugs.
Policy Documents Applicable to Outsourcing Facilities
See the Regulatory Policy Information webpage for applicable policy documents.