Massachusetts Institutes Stricter Compounding Law

New legislation comes 2 years after contaminated steroids from a Massachusetts compounding pharmacy cause meningitis outbreak.

Massachusetts Governor Deval Patrick last week signed legislation regulating compounding pharmacies within its borders that includes new licensing, labeling, education, and oversight requirements, as well as new penalties and fines.

The law comes nearly 2 years after fungal meningitis—contaminated steroids from a Framingham, Massachusetts, compounding pharmacy caused the death of 64 patients, and sickened hundreds throughout the United States. The ensuing investigation revealed numerous violations by the compounding pharmacy making the steroids, the New England Compounding Center.

The Massachusetts Senate and House of Representatives unanimously approved the law prior to Gov. Patrick’s signing.

Under the new regulations, all in-state and out-of-state sterile and complex nonsterile compounding pharmacies would be required to obtain Massachusetts licenses. State inspectors will need to be trained in USP 795 and 797 compounding standards, and would be required to make unannounced, detailed inspections of several types of compounding pharmacies. In addition, the Board of Registration in Pharmacy will be required to publicly report on its investigation and enforcement decisions annually.

According to a fact sheet on the act, the oversight and enforcement portions of the bill will close gaps between FDA and state oversight of compounding pharmacies, while licensing and tracking compounding pharmacies. It also clearly defines “compounding” and “manufacturing,” the fact sheet continues.

The law’s patient safety provisions include uniform compounding standards for sterile and nonsterile compounding, and create quality control, environmental monitoring, and testing requirements. It redefines serious adverse drug events to meet the national standard, while extending adverse drug event reporting to pharmacies, the fact sheet states.

Other portions of the law require clear labels on compounded drugs, and patient assistance hotlines that are staffed during working hours for retail and outpatient compounding pharmacies. In addition, the law requires compounding pharmacies to publicly report adverse drug events, board of pharmacy investigations, and enforcement actions on the Massachusetts’ Department of Public Health website.

The International Academy of Compounding Pharmacists supported the legislation, stating that it would increase oversight of compounding pharmacies.

“The International Academy of Compounding Pharmacists (IACP) applauds Massachusetts’ legislature and governor for enacting a law which will strengthen oversight and inspection of compounding pharmacies, which provide vital medications for thousands of patients across the state,” David G. Miller, RPh, executive vice president and CEO, International Academy of Compounding Pharmacists, said in an e-mail to Pharmacy Times. “Massachusetts now joins many other states that have passed new regulations since the 2012 meningitis outbreak tied to the New England Compounding Center, which according to regulators was a drug manufacturer masquerading as a pharmacy. We support the law’s provisions to license nonresident compounders and to enhance the inspection program for pharmacies. Because we learned that state and federal regulators missed clear warning signs about NECC’s operations, the key to this law’s success lies in its implementation and enforcement.”