Mass. Adopts Stricter Rules, Penalties For Compounding Pharmacies
The emergency regulations will allow the state to monitor contamination and the volume of medicines being made.
Reuters: Massachusetts Tightens Rules For Compounding Pharmacies
Massachusetts adopted new regulations on Thursday that it said will allow it to keep a closer eye on compounding pharmacies, a class of drug supplier linked to the U.S. meningitis outbreak that has so far killed 29 people. The state, home to the New England Compounding Center that produced the injectable steroids at the heart of the outbreak, said the new rules give it the authority to track the volume and distribution of drugs that compounding pharmacies sell to determine if they are operating like manufacturers (Malone, 11/1).
The Boston Globe: Pharmacy Board Adopts New Rules
Specialty pharmacies similar to the Framingham compounding company linked to the national fungal meningitis outbreak will be required to report to the state the volume of medications they are making and whether they have detected contamination in their laboratories, under emergency state regulations adopted Thursday. Later in the day, federal regulators said they found contamination in two more New England Compounding Center products — preservative-free betamethasone, a steroid used to ease back pain, and cardioplegia solution, a medication used in heart surgery (Lazar, Johnson and Kowalczyk, 11/1).
WBUR: Mass. Board Approves New Regulations For Compounding Pharmacies
The state will start more closely tracking operations at compounding pharmacies, like the one in Framingham blamed for causing a nationwide fungal meningitis outbreak. The Massachusetts Board of Registration in Pharmacy on Thursday approved new emergency regulations so the state can monitor whether specialty pharmacies are operating more like drug manufacturing facilities that require licensing by the U.S. Food and Drug Administration. The board also approved stiffer penalties for violations (11/1).