Pharmacy Compounding of BHRT: A Proposed New Approach to Justify FDA Regulation of These Prescription Drugs

摘要

FDA's recent decision to send warning letters to several pharmacies compounding prescription drugs for "bioidentical" hormone therapy is the latest round in a long-standing dispute between the Agency and the pharmacy profession over regulation of pharmacy compounding of prescription drugs. FDA has stated that it recognizes the essential role of compounding of prescription drugs in patient care, and is not interested in interfering with those pharmacies engaged in "traditional" compounding. Previous efforts to regulate compounding pharmacies have revolved around efforts to either classify such pharmacies as manufacturers, thus subject to FDA jurisdiction, or to simply argue that the compounded drugs are new drugs and thus subject to the NDA requirements of the Food, Drug, and Cosmetic Act. Federal courts have not readily embraced either approach. Recent activities by several predominately Internet-based compounding pharmacies involving aggressive promotion of bioidentical hormone therapy to a national patient audience as an effective and safer wholesale replacement for established commercial prescription drugs. This article argues that this activity does not constitute compounding in the traditional sense and thus should be subject to FDA regulation. The article suggests new terminology and suggests a novel way of arguing for FDA regulation of this pharmacy activity that is not based on either the manufacturing or new drug arguments, and that would allow FDA to distinguish between those compounding pharmacies that are engaged in traditional compounding from those that are not.