Compound Pharmacy Bill Will Block FDA Authority Over Small Operations

A recently proposed House bill would restrict the FDA’s authority over traditional compounding pharmacies, but would also create a new sub-class of pharmacy that is a blend between a compounder and a drug manufacturer, which some critics have suggested will put the public at even greater risk.  

The legislation, known as the Compounding Clarity Act (H.R. 3098) (PDF), was filed on September 12 by House representatives Morgan Griffith, a Virginia Republican, Gene Greene, a Texas Democrat, and Diana Degette, a Colorado Democrat.

The bill comes about a year after health investigators discovered a nationwide fungal meningitis outbreak that was linked to contaminated epidural steroid injections distributed throughout the United States by a single a compounding pharmacy in Massachusetts.

The proposed legislation, which is similar to one already proposed in the U.S. Senate, would undercut the FDA’s recent enforcement efforts to prevent another outbreak by blocking its authority over traditional compounding pharmacies. However, it would give the agency increased authority over large-scale compounders, and set guidelines over which compounding pharmacies would be exempt from FDA oversight and which would not.

The fungal meningitis outbreak is blamed for the deaths of 64 people nationwide and is believed to have sickened at least 760 others. The outbreak was tracked back to the New England Compounding Center (NECC), which was forced to recall its drugs and shut down. The pharmacy has since filed for bankruptcy under the weight of impending lawsuits.

During the investigation, it was discovered that the FDA and Massachusetts health officials knew there was a problem with NECC, but did not take strong enough action. Since then, the FDA and state agencies have been hammering down on compounding pharmacies, resulting in numerous recalls. However, a number of court decisions throughout the years have left the FDA’s authority over compounding pharmacies in doubt, and some have resisted the agency’s efforts to recall potentially unsafe drugs.

Traditionally, compounding pharmacies are small scale operations overseen by state boards. They create specific drug compounds on a per-prescription basis for local hospitals when that drug is not available elsewhere. However, more and more have begun mass producing drugs and distributing them nationally, operating as what some call “stealth drug manufacturers,” meaning their drugs get made without federal oversight. This appears to have been the case with NECC, which distributed 17,000 epidural steroid injections nationwide that were later linked to the fungal meningitis outbreak.

Bill Creates New Type of Compounding Pharmacy

The House bill would define which compounding pharmacies are traditional operations that work on a small scale and would be exempt from the FDA’s oversight, while setting standards of operation for those facilities. It would also decide which were non-traditional, large-scale operations that were subject to more stringent regulations.

Critics of the proposed plan say that the FDA should have jurisdiction over all compounding pharmacies, and that there should not be a new, hybrid, category of large-scale compound drug manufacturer. Instead, those operations should be subject to the same new drug approval rules as drug manufacturers.

Public watchdog groups, like Public Citizen, say the bills endanger the public by increasing the risk of another outbreak. However, the bills have been endorsed by lobbying groups for pharmacists like the National Community Pharmacists Association, which criticized the Senate version of the bill for allowing the FDA to step in when compounding pharmacies manufacture an FDA-approved drug because it is in low supply.