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 manufacturing practice ("cGMP"), and some labeling requirements. Section 503B exempts outsourcing facilities from new drug approval requirements and some labeling and distribution requirements but requires these facilities to register with FDA, subjects them to cGMP requirements, and restricts their compounding activities to drugs on FDA's "clinical need list." FDA issued a final guidance for individuals and pharmacies intending to compound drugs reiterating the requirements of section 503A, describing interim policies for provisions that require further FDA action, and providing a nonexhaustive list of potential enforcement actions against those who do not comply with FDCA requirements. A separate draft guidance for outsourcing facilities that will register with FDA under FDCA section 503B describes cGMP requirements related to sterility assurance programs and general safety measures for compounded products.
In addition, FDA is reopening the nomination process for two lists of bulk drug substances (active pharmaceutical ingredients, or APIs) that may be used to compound drug products under FDCA sections 503A and 503B. According to FDA, the original December 2013 request did not receive adequate responses. Interested parties may submit nominations through September 30, 2014.
Finally, in addition to developing the new regulatory tools, FDA continues to demonstrate that oversight of certain compounding activities is a priority for the Agency through its compliance and enforcement programs. FDA has been increasing its monitoring of compounding pharmacies through inspections, and the Agency regularly issues warning letters to facilities it determines are not in compliance with FDA regulations and the FDCA as amended by DQSA.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.