Drugs

Information for Outsourcing Facilities

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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.

Outsourcing facilities:

  • 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

Product Reporting Information

Section 503B(b) of the FD&C Act requires outsourcing facilities to report to FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six-month period. The agency posts this information to assist the public in identifying outsourcing facilities that have produced certain drug products that they need. The outsourcing facility product report (XLS - 223KB, updated 9/13/2018) lists drug products that outsourcing facilities reported were produced during prior reporting periods. This retrospective report does not identify drug products that outsourcing facilities intend to produce in the future.

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Policy Documents Applicable to Outsourcing Facilities

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Page Last Updated: 09/28/2018
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