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.
Comments
A draft of new rules is available on the Web site of the Department of Punlic Health. [ November 1, 2012, at http://www.mass.gov/eohhs/docs/dph/quality/boards/necc/121101-pharmacy-board-draft-emergency-regs.pdf ] The existing state pharmacy regulations can be found on the Web site of the Massachusetts trial court law library. [ at http://www.lawlib.state.ma.us/source/mass/cmr/cmrtext/247CMR6.pdf ] ----------------------------------------------------------------------------------------------------------- The Globe's headline is misleading. So far, Massachusetts has no rules specific to compounding pharmacies. The new rules will not remedy that situation. They apply broadly to all state-licensed pharmacies and do not take account of pharmacies performing only compounding, providing no ordinary pharmacy services. Those are the pharmacies which are behaving like drug manufacturers but are still regulated like pharmacies. ----------------------------------------------------------------------------------------------------------- In draft rules, a new section of the Code of Massachusetts Regulations 247 CMR 6.15 is added. A criticai element is subsection (5), providing that "[e]very pharmacy...that performs central intravenous admixture services...or engages in sterile compounding shall report to the Board [of Pharmacy] every six months." Items to be reported include the number of prescriptions dispensed, states in which the prescriptions were distributed and [laminar flow] hood certifications. ----------------------------------------------------------------------------------------------------------- In subsections (6) and (7), new reporting requirements include "within 7 business days all adverse events relating to preparation of medications" and "within 7 business days all abnormal results, including failure of certification...and identification of environmental contaminants...." ----------------------------------------------------------------------------------------------------------- The draft regulations are deficient in omitting reporting about types of drugs prepared. Existing state regulations about clean rooms and laminar flow hoods omit any minimum filter ratings and any limits on biological contaminants, and the draft regulations fail to address those critical omissions. The draft regulations are broadly deficient in failing to require electronic reporting and in failing to provide for prompt disclosure of reports to the public.
Here we go again. Just another (state/federal regulatory agency's) example of closing the barn doors AFTER the horses have run off.
Will they ever learn!?