The FDA is not alone in cracking down on drug compounders. State authorities in Massachusetts have been taking action after being caught off-guard last year when a nationwide, fatal meningitis outbreak was tied to a compounder there. It recently gave orders to halt operations at two compounders.
The enforcement illustrates the division of powers the FDA supports in legislation pending in Congress that would give it authority over the big players and leave local, more traditional compounders to the states. It also came as a compounding pharmacy in Texas is challenging the FDA's authority over its products.
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, dozens fatally, who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. Only four of 37 compounders inspected passed their inspections, she said.
Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. It is looking at large compounders that operate more like small drug manufacturers and often ship nationally.
The FDA wants Congress to clarify its authority over compounders and is supporting a bill that 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 any longer making 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 is playing 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 customers with concerns can have the results of those tests sent to them as proof.
That fight is playing out even as the FDA last week said that another Texas compounder, Specialty Compounding of Cedar Park, 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.