A 503B outsourcing facility is a registered establishment with the FDA under Section 503B of the FD&C Act, that compounds sterile medicinal products in bulk for healthcare providers, adhering to rigorous quality and safety standards and regulatory requirements.
 

Outsourced compounders produce large batches of compounded medications for healthcare institutions without patient-specific prescriptions. These facilities supply drugs that are unavailable commercially or in shortage, supporting providers in meeting patient needs.
 

503B facilities are regulated by the U.S. Food and Drug Administration (FDA) and must comply with Current Good Manufacturing Practice (cGMP) standards. They are required to:

• Register annually with the FDA and pay an establishment fee.

• Follow applicable sections of Title 21 CFR Parts 210/211 Drug GMPs and all applicable predicate rules under Title 21.

• Follow USP <797>, <800>, and <825> standards for sterile compounding.

• Maintain rigorous quality control, including sterility, potency, and endotoxin testing for each batch.

• Be subject to FDA inspections, although facilities can begin compounding and shipping medications after registration, even before inspection.

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The Auditing Group provides pre-FDA inspections and Gap Analysis services to assist companies in preparing and satisfying U.S. FDA requirements.  

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