Compounding pharmacies, one of the fastest growing sectors in retail pharmacy, may soon be able to expand the market for their products in exchange for agreeing to be placed directly under federal oversight, according to U.S. Food & Drug Administration Commissioner Scott Gottlieb.

Currently, a sterile compounding pharmacy may voluntarily register with the FDA as an "outsourcing facility" under the 2013 Drug Quality and Security Act, agree to meet certain manufacturing standards, and could then sell sterile compounds in bulk to be stockpiled by hospitals and physician practices without individual prescriptions.  Non-registered compounding pharmacies remained under state board authority, and were limited to compounding drugs for patient-specific prescriptions. Since passage of the Act, very few compounding pharmacies have registered, partially due to what were perceived to be onerous federal requirements, and the applicability of the Act to sterile compounds only.  Sterile compounding pharmacies constitute only a small percentage of compounding pharmacies in general.

The requirements under the Act could become less onerous, opening up new opportunities for compounding pharmacies.  According to Commissioner Gottlieb, the FDA is preparing new draft guidance that will eliminate some of the stricter federal standards for smaller pharmacies that create low-risk compounding drugs, creating the possibility for registering pharmacies to sell their products to physicians' offices and other facilitates. The draft guidance is expected out within the next 6-8 weeks, at which point a clearer picture will emerge for compounding pharmacies.

If you have questions pertaining to the scope or oversight of compounding practice or other issues pertaining to compounded medications, feel free to contact our expert pharmacy attorneys by phone at 212-668-0200 or by email at info@mdrxlaw.com.