Drug Compounders Regulation Discussed

FDA officials met with their public health counterparts from 50 states last week about best measures to strengthen rules that govern compounding pharmacies in the wake of a national meningitis outbreak caused by a tainted product produced by a Massachusetts pharmacy. Patients who were affected received contaminated preservative-free methylprednisolone acetate steroid injections from New England Compounding Center (NECC) used to treat back and joint pain. So far over 600 cases have been attributed to the contamination, with 39 deaths attributed. The meeting was the first public discussion for the agency since FDA Commissioner Hamburg testified before Congress in November regarding what measures could be undertaken to address drug compounding, or tailor-making of medicine for individual patients.

Unlike drug manufacturers, compounding harmacies are primarily regulated under state law via state boards of pharmacy. The public hearing was convened to gather information for the FDA on gaps in the regulatory net and how the states view the role of the agency. Some states have requested that the FDA handle large-scale compounders such as NECC. 

Current law does not require compounders to give the FDA access to their books. Notably, about half of all the court orders the agency obtained over the past decade were for pharmacy compounders, although compounders are only a small part of the agency’s regulatory responsibilities.

At the testimony in November, the FDA stressed that it was unable to effectively monitor the compounding pharmacies and sought more authority for oversight. The FDA’s critics argue that the agency already has all the legal authority to police compounders. Noting that many compounders have been operating as major drug manufacturers, shipping to states across the country, critics have argued that the FDA should be using its jurisdiction over drug manufacturers to regulate those companies’ activities.

The FDA contends it is not as simple as labeling compounding pharmacies as drug manufacturers. Doing so would effectively require compounding pharmacies to file new drug applications for each product made, which could be costly and time-consuming for products that do not need it, such as IV feeding tube bags. In turn, this could affect the supply chain, especially when there are drug shortages. Under consideration is an oversight category for large-scale compounders, apart from the drug manufacturers.

Whether the FDA steps in and adopts a common pathway to address state and industry concerns remains to be seen, as there are requests for changes from compounding pharmacy groups to emergency state regulations following the Massachusetts contamination.