What happened
FDA describes human drug compounding as the combining, mixing or altering of drug ingredients by specified licensed professionals, or supervised personnel at an outsourcing facility, to create medication tailored to an individual patient’s needs. It states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality before marketing. FDA says its compounding program seeks to protect patients from poor-quality compounded drugs while preserving access to lawfully marketed products for patients with medical need. The page provides links on laws, policies, risk alerts, bulk drug substances, outsourcing facilities, registrations, inspections, recalls, state information and the Compounding Quality Center of Excellence.
Why it matters
From a GMP and manufacturing perspective, FDA’s emphasis on the absence of premarket review and the possibility of poor-quality compounded drugs makes product quality and patient risk central considerations for compounders and outsourcing facilities. The linked resources may be relevant for monitoring FDA policies, facility actions, recalls, ingredient-related information and quality-focused initiatives. This overview itself does not specify manufacturing controls or new compliance obligations.
Key topics: Risks of non-FDA-approved compounded drugs, Oversight of compounders and outsourcing facilities, Compounding laws, policies and FDA actions