503A compounding pharmacy

What can a 503A pharmacy compound?

Section 503A applies to compounding by a licensed pharmacist in a state-licensed pharmacy or federal facility, or by a licensed physician, that is not registered with FDA as an outsourcing facility [1]. Compounding under 503A must follow receipt of a valid prescription for a named patient, or occur in limited quantities shortly before one arrives [1]. In exchange, drugs made this way are exempt from FDA's manufacturing-quality (CGMP) rules, standard drug labeling requirements, and premarket approval [1].

Who oversees a 503A pharmacy?

State boards of pharmacy hold primary, day-to-day oversight of 503A pharmacies rather than FDA [2]. That is the main split from a 503B outsourcing facility, which registers with FDA and is inspected on a risk-based schedule [2]. FDA still warns that poor compounding practices anywhere can cause contamination or incorrect active-ingredient levels, leading to serious patient harm [2].

Can a 503A pharmacy copy an FDA-approved drug?

Generally no. FDA treats a compounded drug as essentially a copy of an approved drug if it shares the same active ingredient, a similar strength, and the same route of administration as a commercially available product, unless a prescriber documents a patient-specific reason it differs [3]. FDA has said it will not act against a 503A pharmacy that fills four or fewer such prescriptions in a calendar month [3].