Massachusetts Cracks Down on Compounding Pharmacies

The fungal meningitis outbreak last fall spawned a plethora of random inspections at compounding pharmacies in Massachusetts. With a total of 37 inspected facilities, only 4 have been following the industry standards for production of compound drugs. In total, 11 pharmacies were ordered to partially or completely shut down their operations and produce a plan of correction to rectify their deficiencies. Another 21 received citations for minor infractions. The state shut-down or cited 80% of the compounding pharmacies in the state, citing non-sterile practices and more. One Massachusetts compounding pharmacy, PharMerica, has received a cease-and-desist order in the Mass plant; spawning an inspection by Rhode Island official into their other plant. The Rhode Island inspection led to another cease-and-desist order after it was found the location also had non-sterile practices, as well as unlicensed technical staff. The fatal meningitis outbreak this past October sickened just under 700 people nationwide and killed 45. It was shortly after the first deaths were reported that the state began its random inspections. Involved health officials agree that the results have been troubling. However, the inspection process has led to enhanced compliance and serious corrective measures to ensure safe compounded medications. Many of the cited pharmacies have already completed and submitted a plan of correction and have been cooperative. The pharmacy that produced the tainted steroids, New England Compounding Center, was immediately shut down. Its sister company, Ameridose voluntarily agreed to terminate operations during the investigations, later to have similar problems identified at their location. Through the investigation, it was found that New England Compounding was mass producing the steroidal medications. Compounding pharmacy production is supposed to tailor individual medication for specific patient needs, with no mass production involved. New England Compounding filed for bankruptcy in December 2012. All states where compounding pharmacies exist are looking hard at what can be done through their local governments. Many states do not currently have pharmacy regulations as Massachusetts has. All states are calling for more pharmacy inspectors as they are currently working with a significantly lower number of inspectors to the amount of pharmacies in their territories. Legislation is also being developed at a federal level. Sources: Reuters - http://www.reuters.com/article/2013/02/05/us-meningitis-pharmacies-violations-idUSBRE91414J20130205 Chem Info - http://www.chem.info/News/2013/02/Plant-Operations-Pharmacies-Ordered-to-Shut-Down-after-Inspections/ Boston Globe - White Coat Notes - http://www.boston.com/whitecoatnotes/2013/02/05/just-massachusetts-compounding-pharmacies-passed-surprise-health-inspections/zFT7FKklNPfj6EdW4tYu1L/story.html USA Today - http://www.usatoday.com/story/news/nation/2013/02/05/massachusetts-reprimands-drug-compounder/1894927/