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U.S. Department of Health and Human Services

Drugs

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Outsourcing Facilities

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.

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 the exemption from current good manufacturing practice (CGMP) requirements.

Outsourcing facilities:
  • 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.
     

Registered Outsourcing Facilities

 
Guidance for Industry