State has ordered full or partial shutdowns at 11 pharmacies

The state has issued cease and desist letters to 11 pharmacies for a range of violations, and cited another 21 for minor deficiencies, since inspectors started making unannounced visits in the wake of a nationwide fungal meningitis outbreak that began at a Framingham compounding pharmacy.

The disturbing results of these inspections, and the need for regulators to force the closure of all or part of 11 compounding pharmacies, are further evidence of another systemic failure of oversight by state government, said Senate Minority Leader Bruce Tarr in a statement. If the current system tolerated this degree of regulatory noncompliance, then clearly, its time for serious reform.

Beyond merely distributing medication, compounding pharmacies produce special batches of medication for individual patients. New England Compounding Center was allegedly using its compounding license to produce wholesale quantities of medications in violation of its license, and unsanitary conditions lead to the shipping of tainted steroids causing 696 infections and 45 deaths in 20 states, according to the Centers for Disease Control.

In the wake of that outbreak, the Board of Registration in Pharmacy started unannounced inspections on the states 40 sterile compounding pharmacies, and has since ordered 11 pharmacies to close or shut down some of their operation, according to the Department of Public Health. Eight have since submitted corrective action plans. The pharmacies are: Apothecare South Shore, of Brockton, which was ordered to stop compounding on Dec. 20 after it was found to be out of compliance with several regulations; Baystate Home Infusion, of Springfield, was ordered to stop all sterile compounding on Dec. 12 after it was found to be out of compliance with standard preparation methods; Home Infusion Solutions, of Falmouth, was ordered to stop sterile compounding on Dec. 27 after problems with its facility and process came to light; Lenox Village Pharmacy, of Lenox, was ordered to stop sterile compounding on Dec. 12 after its preparation methods were found to be out of compliance; OncoMed Pharmaceuticals, of Waltham, was issued a cease and desist on Nov. 21 related to its storage of chemotherapy drugs; PalliMed Solutions Pharmacy, of Woburn, was ordered to stop producing sildenafil citrate on Nov. 27 after inspectors discovered the pharmacy used improper components in the drugs preparation; PharmaHealth Pharmacy, of New Bedford, was ordered to stop sterile compounding on Feb. 1, which the pharmacy had previously claimed it was not doing, and it was cited for its clean room controls, sterile compounding practices, training and environmental monitoring; PharMerica, of Brockton, was ordered to stop all sterile compounding on Dec. 27 after problems arose with the facility, controls, and preparation; Western Mass Compounding Center, of West Springfield was ordered to stop sterile compounding on Dec. 6 after non-compliance issues arose with preparation and dispensing sterile medications, as well as storage and handling or hazardous medications; West River Pharmacy, of Marlborough, was ordered to stop sterile compounding Dec. 20 over non-compliance with facility design and control; and Whittier Pharmacist, of Bradford, was issued a full cease and desist on Nov. 28 after the discovery of significant deficiencies in the structure and engineering of the clean room. Apothecare, Baystate, Home Infusion Solutions, OncoMed, PalliMed, PharMerica, Western Mass and West River all submitted correction plans for review.

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State has ordered full or partial shutdowns at 11 pharmacies