Outsourcing Facilities — Registration and cGMP
Creates the outsourcing-facility category: a compounder that registers with FDA, complies with cGMP, reports adverse events, and is inspected on a risk-based schedule, in exchange for being able to compound without patient-specific prescriptions. Added by the Drug Quality and Security Act of 2013 following the 2012 fungal-meningitis outbreak.
Facilities compounding sterile preparations for distribution to healthcare providers without individual prescriptions. Registration is voluntary in form but effectively mandatory for that business model.
- 01Registration with FDA as an outsourcing facility, with product reporting
- 02Compliance with cGMP for the preparations made
- 03Direct supervision by a licensed pharmacist
- 04Adverse-event reporting to FDA
- 05Bulk substances limited to the 503B list or drugs on the shortage list
- 06Labelling as required for compounded preparations
FD&C Act §503B: frequently asked questions
Quick answers to common questions about FD&C Act §503B.
What is FD&C Act §503B?
FD&C Act §503B — Outsourcing Facilities — Registration and cGMP — is a statute issued by the Food and Drug Administration (United States). Creates the outsourcing-facility category: a compounder that registers with FDA, complies with cGMP, reports adverse events, and is inspected on a risk-based schedule, in exchange for being able to compound without patient-specific prescriptions. Added by the Drug Quality and Security Act of 2013 following the 2012 fungal-meningitis outbreak.
Who does FD&C Act §503B apply to?
Facilities compounding sterile preparations for distribution to healthcare providers without individual prescriptions. Registration is voluntary in form but effectively mandatory for that business model.
What are the key requirements of FD&C Act §503B?
FDA FD&C Act §503B requires, among other things: Registration with FDA as an outsourcing facility, with product reporting; Compliance with cGMP for the preparations made; Direct supervision by a licensed pharmacist; Adverse-event reporting to FDA.
When was FD&C Act §503B last updated?
The current version of FD&C Act §503B dates from November 2013.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When FD&C Act §503B — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.