To Register or Not to Register – Compounding Pharmacy Dilemma

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”.

For about the past two years (since the fungal meningitis outbreak occurred), the FDA has been proactively and for-cause inspecting compounding pharmacies, and FDA plans to take aggressive action, including enforcement actions, as appropriate, to protect the public health.

“On March 20-21, 2014, the U.S. Food and Drug Administration (FDA) convened an inter-governmental working meeting of state government officials, including officials from the District of Columbia and Puerto Rico.

Attendees included officials from Boards of Pharmacy, Health Departments, the Centers for Disease Control and Prevention (CDC), and representatives from organizations that represent state officials, including the National Association of Boards of Pharmacy (NABP), the Association of State and Territorial Health Officials (ASTHO), and the National Conference of State Legislatures (NCSL).

During this meeting, participants discussed oversight of compounding pharmacies and implementation of the Drug Quality and Security Act (DQSA). The DQSA, P.L. 113-54, was signed into law on November 27, 2013, and contains provisions relating to federal and state oversight of compounded human drugs.”

Topics addressed by the participants from the FDA, state organizations and the industry included an overview of the compounding Quality Act, issues regarding Federal and State Communication initiatives and practices, inspection of sterile compounding pharmacies; the Memorandum of Understanding between FDA and States; State enforcement priorities, as well as state legislation and regulations.  To see the full list of presentation and their contents, click here.

The landscape is changing quickly so if you are involved in compounding issues be certain to assure you are operating within the current guidelines and FDA and State expectations, to avoid any problems with your practice.