While supervision of pharmaceutical manufacturing by the FDA has seen only partial success in preventing distribution of contaminated products, supervision of compounding pharmacies by states has been notably less successful. Compared to some other states, Massachusetts is laggard. It currently has neither laws nor regulations specific to pharmacies that specialize in compounding. -------------------------------------------------------------------------------------- The longstanding lapses have been glaringly exposed by pharmaceutical poisoning associated with New England Compounding Center in Framingham, MA, as documented by the U.S. Food and Drug Administration and Centers for Disease Control and Prevention. Embarassed by the disaster, state's Department of Public Health has recently been issuing statements suggesting the department has been proactive. -------------------------------------------------------------------------------------- On October 8, 2012, Dr. Madeleine Biondolillo, Director of Health Care Safety and Quality in the department, issued a misleading statement, claiming that in Massachusetts "licensed compounding pharmacies are only permitted to prepare and dispense medications pursuant to a prescription from a registered practitioner for an individual patient...." For a prescription drug like methylprednisolone that is not regarded as a "controlled substance," there is in fact no such state law or regulation. -------------------------------------------------------------------------------------- During the week beginning October 7, 2012, the department issued an undated "advisory for compounding pharmacies and pharmacists," misleadingly claiming Massachusetts General Laws (MGL) Chapter 94C, Section 21, and state regulation 105 CMR 721 require state-licensed "pharmacies and pharmacists to dispense medications pursuant to a valid prescription from an authorized practitioner for a specific patient." -------------------------------------------------------------------------------------- In fact, MGL C. 94C regulates "controlled substances," and 105 CMR 721 specifies formats and security for prescriptions. Neither prohibits a state-registered pharmacy from compounding drugs to order and delivering them to a licensed physician, not to a patient, without identifying patients with whom the physician uses the drugs. The fact that the state has several compounding pharmacies who have been openly doing so for many years without state interference also undercuts arguments that it is an illegal practice in Massachusetts. -------------------------------------------------------------------------------------- The only state regulation that clearly affects state-registered pharmacies specializing in compounding is one requiring: "A pharmacist shall observe the standards of the current United States Pharmacopoeia" (USP). [ 247 CMR 9.01(3) ] Like all other related state laws and regulations, that one concerns licensing of pharmacists and says nothing about operation of pharmaceutical facilites. -------------------------------------------------------------------------------------- USP is administered by a private organization, not an arm of government. It is focused on chemical purity and accuracy, not on manufacturing processes, and its administrators have no enforcement powers. A mere standard, unsupported by frequent inspection and continuous monitoring, does nothing to protect the public from contaminated products. Massachusetts has never operated any program for frequent inspection and continuous monitoring of compounding facilities, and currently it is completely unprepared to do so. -------------------------------------------------------------------------------------- [ state documents listed at http://www.mass.gov/eohhs/gov/departments/dph/news-and-updates.html ] [ Dr. Madeleine Biondolillo statement at http://www.mass.gov/eohhs/gov/newsroom/press-releases/dph/statement-from-the-department-of-public-health-121008.html ] [ Department of Public Health advisory at http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy-alert-compounding.pdf ] [ MGL C 94C laws at http://www.malegislature.gov/Laws/GeneralLaws/PartI/TitleXV/Chapter94C ] [ MGL C 112 laws at http://www.malegislature.gov/Laws/GeneralLaws/PartI/TitleXVI/Chapter112 ] [ 105 CMR regulations at http://www.lawlib.state.ma.us/source/mass/cmr/105cmr.html ] [ 247 CMR regulations at http://www.lawlib.state.ma.us/source/mass/cmr/247cmr.html ]