The State Legislature recently took final action on a bill that creates new regulations and limitations on the practice of pharmacy compounding in Massachusetts, after a committee of negotiators reached agreement on the final language for the bill.
Sen. John Keenan, who represents Abington, Braintree, Holbrook, Quincy and Rockland, was the lead Senate negotiator on the bill, and says the new law will “bring to light an industry that previously operated in the shadows.”
Work on new oversight measures began in late 2012, after egregious errors and violations by the New England Compounding Center in Framingham left 64 people dead and more than 700 severely ill across the country by a meningitis infection. Subsequent unannounced inspections by the state’s public health department led to more than a dozen other compounding pharmacies being shut down across the state.
Keenan, who co-chairs the Joint Committee on Public Health, states that the compounding industry was originally intended to fill a legitimate medical need. Typically, these pharmacies modify approved drugs – for example by adjusting a dosage, removing an allergen or changing a drug’s method of administration – to meet a medical need that is unique to each patient.
Unlike manufacturers that produce drugs in large batches, compounding pharmacies typically produce a single prescription at a time. The compounding pharmacies were exempted from federal regulation and oversight.
“We found that the combination of federal exemption and the lack of state oversight, allowed the industry to grow well beyond its intended scope,” said Keenan. “As a result, fraudulent and unsafe practices destroyed lives.”
The bill enacted, pending the Governor’s approval, creates three new specialty license categories – for sterile compounding, non-sterile compounding and compounding within a hospital or institutional setting – for pharmacies in Massachusetts, and also requires that out of state pharmacies register and comply with state regulations.
It also reconstitutes the Board of Registration in Pharmacy, adding members with expertise in compounding, and gives the board the resources, capacity and authority to inspect compounding pharmacies. State inspectors would be specially trained in compounding, use a standardized inspection checklist and standards, and conduct unannounced inspections at least annually.
Other provisions in the bill would require additional training for pharmacists employed by a compounding pharmacy; reform the way errors and drug recalls are reported to regulators and to the public; create new penalties for violations of pharmacy regulations; and extend whistleblower protections for pharmacy employees.
The six-member conference committee that negotiated the bill was chaired by Keenan for the Senate, and by Rep. Jeffrey Sanchez for the House, and also included Sen. Stephen Brewer, Senate Minority Leader Bruce Tarr, Rep. Brian Dempsey and Rep. David Vieira.
This process has been long in the making. We wanted to ensure our consideration of this complex topic was thorough, and that our outcome would be a comprehensive policy that can be emulated across the country,” Keenan said after the bill was passed. “With this legislation, we will go from the state where an unregulated pharmacy compounded a substance that killed dozens of people and caused more than 700 to deal with serious illness, to the state which provides patients with the best safety standards in the country.”