Outsourcing Facilities: Section 503B

The Drug Quality and Security Act (DQSA) can be separated into two sections: Title I addresses drug compounding and Title II relates to drug supply chain security. Section 503A of the Food, Drug and Cosmetic Act (FDCA) addresses compounding requirements, where as Section 503B defines and describes “outsourcing facilities.”

Outsourcing Facilities are defined as a facility at one geographic location that:

  1. Compound sterile drugs;
  2. Have registered as an outsourcing facility with the FDA; and
  3. Comply with all requirements in Section 503B.

Additionally, outsourcing facilities:

  1. Voluntarily register with the Food and Drug Administration (FDA);
  2. Submit to inspections on a risk-based schedule set by the Secretary of Health and Human Services (HHS);
  3. Are not required to be a licensed pharmacy;
  4. May or may not obtain patient-specific prescriptions;
Inspections of outsourcing facilities will be based on the following known safety risk factors:
  1. Compliance history;
  2. Record, history, and recalls linked to the facility;
  3. Inherent risks of compounded drugs;
  4. Inspection frequency and history of the facility;
  5. Whether or not the facility has registered that it intends to compound drug that appear on the list in effect under the FDAs drug shortage list (Section 506E); and
  6. Other criteria to be determined by the Secretary of HHS.

The DQSA, drug compounding and outsourcing facilities remain a hot topic and Baer Law will continue to provide updates as new information becomes available.