To Register or Not to Register – Compounding Pharmacy Dilemma

Written by Robert Moore and Bob Pollock • April 28, 2014

For Compounding Pharmacies, there is a new law (Compounding Quality Act) and a sheriff (the FDA) to enforce the law.  The new law is an amendment to the Food, Drug& Cosmetic Act (FDCA), which (amongst other things) requires that the drugs must be compounded in compliance with Current Good Manufacturing Practices (CGMP) by or under direct supervision of a licensed pharmacist in a registered facility.
Under this new law, some compounding pharmacies will be categorized as “outsourcing facilities”.  Those pharmacies that compound sterile drugs, among others, must register with the FDA as an “outsourcing facility”.
If the pharmacy compounds a solution or suspension using a non-sterile active pharmaceutical ingredient (API or, aka, drug entity) and then, by further processing, renders the final drug product as “sterile”, it must register with the FDA.  If the pharmacy performs “sterile to sterile” transfers or “sterile admixing”, it must register with the FDA.  If by any means the pharmacy compounds a sterile product, it must register with the FDA as an “outsourcing facility”.
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