FDA Continues To Bolster Regulation Of Compounding Pharmacies

Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of approval, labeling, and manufacturing regulations for compounding pharmacies, and it added a new section 503B to exempt certain "outsourcing facilities" from some of these requirements. In an exercise of its expanded authority, FDA recently issued a proposed rule, two guidance documents, and two revised requests for nominations for the bulk drug substances lists.

Historically, compounding pharmacies have been small shops that custom-mixed specific drugs for specific patients; these pharmacies were subject primarily to state pharmacy regulation. More recently, some facilities claiming to be compounding pharmacies have been conducting operations resembling those of drug manufacturers, which are heavily regulated by FDA. The lack of oversight over these compounding pharmacies is considered a key factor in the circumstances that culminated in a 2012 meningitis outbreak that resulted in the death of 64 people and sickened nearly 700 more. The outbreak was traced to products made at a compounding pharmacy.

Earlier this month FDA issued a proposed rule that would add 25 products to the list of drugs that may not be legally compounded under statutory exemptions to the FDCA because these products have been found unsafe or not effective since FDA last published a final rule regarding the list in 1999.

FDA also issued two guidance documents explaining provisions of DQSA, which modified FDCA sections 503A and 503B. The guidance documents describe how the Agency intends to regulate individuals and pharmacies that compound drugs (regulated under section 503A), and sterile drug compounders, also known as outsourcing facilities (regulated under section 503B). Section 503A exempts state-licensed pharmacies, which primarily distribute within their state and compound drugs in response to specific individual prescriptions, from certain FDA requirements such as new drug approval, current good...