Draft legislation introduced by the chairman and ranking member of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) aims to amend the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration authority to oversee certain compounding entities, namely, newly-defined “Compounding Manufacturers.” The legislation defines and distinguishes between a “Compounding Manufacturer” and a “Traditional Compounder.” The legislation attempts to rectify the circumstances that led to last year’s widespread fungal meningitis outbreak that resulted in more than 50 deaths. The draft legislation was met with mixed reaction. The International Academy of Compounding Pharmacies, a main trade group of compounding pharmacies, stated that the draft legislation “creates more confusion and further blurs the jurisdictional authority of regulators” and “may reduce patient and physician access to customized medications.” Below are four key points regarding the draft legislation.
- Compounding Manufacturer Defined: A Compounding Manufacturer is defined as an entity that (i) compounds any sterile drug without receiving a prescription order for such drug prior to beginning compounding; or (ii) repackages a drug using sterile preservative-free single-dose vials or by pooling sterile drugs. However, a pharmacy within a health system that compounds and ships drugs within the health system, including through interstate commerce, is considered a Traditional Compounder, even if the pharmacy compounds drugs for health system patients before receiving a prescription.
- Compounding Manufacturers Compliance Requirements: A Compounding Manufacturer will have several new compliance and reporting requirements regulated by the FDA. These requirements include: (i) ensuring that a pharmacist licensed in the state where the Compounding Manufacturer is operating directly oversees all compounding operations and that operations are in compliance with Good Manufacturing Practices; (ii) filing with the FDA a list of drugs compounded by the Compounding Manufacturer; (iii) reporting adverse events to the FDA; (iv) labeling drugs compounded by the Compounding Manufacturer with a statement that the drug is a compounded drug; and (v) the application of manufacturing registration, inspection and user fee requirements to the Compounding Manufacturer.
- Drugs that May Not be Compounded: Compounding pharmacies would be prohibited from compounding complex dosage forms, biological products, certain marketed drugs and drugs removed from the market for safety and efficacy reasons.
- State Control: States would maintain oversight of Traditional Compounders and pharmacies, but the legislation regarding prohibited compounded products and labeling would apply to both Traditional Compounders and Compounding Manufacturers. Further, the legislation aims to increase communication between and amongst state boards of pharmacy and the FDA. If a state regulatory agency complains to the FDA about a Traditional Compounder in another state, the FDA must promptly relay that information to the relevant state pharmacy board.
If you have questions regarding the draft legislation or regulation of compounding pharmacies, please contact one of the authors.