Compounding pharmacy

What does a compounding pharmacy do?

FDA describes compounding as a licensed pharmacist, licensed physician, or (at an outsourcing facility) someone under a pharmacist's supervision combining, mixing, or altering ingredients to create a medication tailored to one patient's needs [1]. Compounded drugs are not FDA-approved, meaning FDA does not review their safety, effectiveness, or quality before they reach a patient [1]. Compounded medications are not reviewed or approved by the FDA for safety or effectiveness.

What's the difference between a 503A pharmacy and a 503B facility?

A 503A compounding pharmacy is a state-licensed pharmacy that compounds a drug for a patient who has a prescription and is overseen mainly by the state board of pharmacy [2]. A 503B outsourcing facility registers with FDA, is inspected directly by FDA on a risk-based schedule, and, unlike a 503A pharmacy, must follow manufacturing-quality (CGMP) rules [2].

When are compounded drugs used?

FDA recommends compounded drugs be used only for patients whose needs an FDA-approved drug cannot meet, such as an allergy to an inactive ingredient or a need for a different dosage form [2]. Because compounded products skip FDA's premarket review, FDA also warns that poor compounding practices can cause contamination or incorrect ingredient amounts [2].