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.
Read more: Compounding pharmacies: Massachusetts closes 2, FDA fights with 1 in Texas - FiercePharma http://www.fiercepharma.com/story/compounding-pharmacies-massachusetts-closes-2-fda-fights-1-texas/2013-08-21#ixzz2ceGZeSQY
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