FDA not alone in acting on compounding pharmacies

The FDA this year has done an inspection sweep through the largest compounding pharmacies after being caught off guard last year when a nationwide fatal meningitis outbreak was tied to a compounder in Massachusetts. But the federal agency is not alone in trying to get on top of the issues. Authorities in Massachusetts, which have stepped up their own oversight, recently halted production at two drug compounders there.  

The Massachusetts Board of Registration in Pharmacy sent cease-and-desist notices to Medi-Son Solutions in Norwood and sister compounder CarePro in Quincy after an inspection found problems at Medi-Son, according to the Boston Globe. Hearings for the two facilities are in progress. Anne Roach, a spokeswoman for the Massachusetts Department of Public Health said the state stepped up enforcement after last year's outbreak of fungal meningitis that infected hundreds of people and killed dozens who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. She said the state got an extra $1 million to pump up its efforts. It has inspected 37 compounders since the NECC deal, and only four passed, Roach said.

Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. The federal agency is looking at large compounders that operate more like small drug manufacturers and often ship nationally. The FDA is supporting a bill that would establish clear authority of its oversight powers when it comes to compounders. The proposed law would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. They would not have to meet all of the strict regulations that drug manufacturers do, but the law would prevent them from continuing to make the most complex biologic drugs that are more easily contaminated. They also would have to kick in fees for the privilege of having FDA supervision.

Some members of Congress oppose extending the agency's authority, saying it just needs to use the powers it has to do a better job. But a situation that recently played out between the FDA and a compounding pharmacy in Texas is sure to feed the debate. The FDA last week updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas. The FDA said questions of sterility were raised during an inspection of the facility. But the compounder is contesting the FDA's authority and findings. In a notice on its own website, NuVision says the FDA is judging compounders using manufacturing standards and that is not a manufacturer. It claims all of its products are sterile, tested by an outside lab and will provide oversight and that clients with concerns can have the results of those tests sent them as proof.

That fight is playing out even as the FDA last week said that another Texas compounder, Specialty Compounding of Cedar Park, TX, is yanking all of its sterile products after 15 patients at two Texas hospitals contracted bacterial bloodstream infections. Two of those patients have reportedly died.

- here's the Boston Globe story
- see the FDA NuVision Pharmacy notice
- read the NuVision response