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What Is an FDA Outsourcing Facility?

In 2013, The U.S. Food and Drug Administration signed into law The Drug Quality and Security Act, which created a new section called 503B in the Federal Food, Drug and Cosmetic Act (FDCA). This act enables a compounding pharmacy to become a 503B outsourcing facility.

The legal definition of an outsourcing facility is: 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.

A compounding pharmacy must elect to register as an outsourcing facility, pay an annual registration fee and meet specific conditions in order to qualify as exempt from the FDCA.

 

What Does an FDA 503B Outsourcing Facility Do?

According to the FDA, an outsourcing facility is one that:

  • – Compounds sterile drugs (although it may also compound non-sterile drugs as well)
  • – Has chosen to register itself as an outsourcing facility
  • – Has complied with all of the regulations required within section 503B
  • – Must conduct all compounding by or under the direct supervision of a licensed pharmacist, although it’s not mandatory for the facility to be a licensed pharmacy
  • – May or may not obtain prescriptions for identified individual patients

 

FDA 503B Outsourcing Facility Requirements

FDA Outsourcing Pharmacy Pharmacist Checking Medications

  • – An outsourcing facility must comply with current good manufacturing practice (CGMP) requirements
  • – All compounded drugs must be compounded under the direct supervision of a licensed pharmacist within the facility
  • – All compounded drugs must be inspected by the FDA

Outsourcing facilities must also report on information about all products compounded on location, including:

    • * A list of all products compounded in the past six months
    • * The source of the ingredients of those products
    • * Adverse events that occur

 

What Are the Benefits of a 503B Outsourcing Facility?

  • Good for Office Use: 503A compounding pharmacies are designed to dispense for home use, while 503B outsourcing facilities may manufacture for office use.
  • Frequent Monitoring: Environmental monitoring must be performed per production shift in primary compounding areas and weekly in secondary compounding areas.
  • Quality Control: 503B outsourcing facilities are required to maintain their own quality department as its own autonomous entity to conduct investigations.

 

How Can I Find Public Info About 503B Outsourcing Facilities?

For additional information about outsourcing facilities that’s been reported to the FDA over the past two years, visit the Outsourcing Facility Product Report searchable database.

 

Key Takeaways

  • FDA Outsourcing Definition: An FDA 503B outsourcing facility is 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.
  • FDA Requirements for 503B Outsourcing Facilities: An outsourcing facility must compound drugs under the direct supervision of a licensed pharmacist within the facility, have their compounded drugs inspected by the FDA and comply with (CGMP) requirements.
  • Benefits of a 503B Outsourcing Facility: they are good for office use, and require frequent monitoring and quality control.

 

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