State regulators say controversial 21-day waiting period for closed pharmacies will remain
State regulators said Thursday they will keep the most controversial aspect of emergency regulations tightening oversight of Massachusetts compounding pharmacies, despite protests from several pharmacy groups.
At issue is a new rule, adopted by the Board of Registration in Pharmacy Nov. 1, that allows the state to shut down a pharmacy for 21 days without a hearing to “protect the public health, safety or welfare.”
The emergency rules were adopted in the wake of the national fungal meningitis outbreak that has killed 39 people and sickened 620 who received tainted medications from Framingham-based New England Compounding Center.
Pharmacy groups testified during a public hearing earlier this month that the three-week period without an appeal was excessive and could delay filling prescriptions needed by patients. They asked the board to shorten the span to between three and seven days.
But Iyah Romm, policy director of the Bureau of Healthcare Safety and Quality, which oversees the pharmacy board, said bureau staff conducting unannounced inspections of compounders have found they need 21 days to thoroughly investigate a facility.
“If we shorten the length, you will get more people focusing on getting a hearing, rather than on a plan of correction to fix the problems,” Romm said.
Board chairman James DeVita and secretary Karen Ryle said at Wednesday’s meeting that they believe 21 days was too long and suggested it be shortened to 14 days. All other members opted for the 21 days in an informal poll of the board.
The new regulations also require pharmacies and pharmacists to report to the board all “non-routine” notices, correspondence, and disciplinary actions they receive, such as from federal regulators. The provision apparently responds to lawmakers who have said the meningitis outbreak highlighted gaps in communication and oversight between state and federal regulators.
But several members said they worried that provision was too vague.
“I am concerned about the amount of paperwork that would be coming in and something important would get lost in that blizzard,” DeVita said.
Board members put off a final vote on the regulations until Jan. 8.
In other action, the board received a tutorial from Assistant Attorney General Jonathan Sclarsic about the state’s Open Meeting Law, which requires that most meetings of governmental bodies be held in public.
Right after that, the board voted to go into closed session to discuss complaints filed by The Boston Globe over alleged violations of the Open Meeting Law. The newspaper’s lawyer informed the board prior to the executive session that it believed the law required the discussion to be in public.
The paper filed formal objections about the board’s lack of any public notice of an October meeting when it apparently voted to seek permanent surrender of New England Compounding’s license. It also objected to the board’s lack of adequate public notice, as required by law, of at least 48 hours before its Nov. 1 meeting, when it passed the emergency regulations.
The board has twice requested from the state Attorney General’s office an extension of the 14-day time period required under law to respond to Open Meeting Law complaints.
A Dec. 17 letter from Sclarsic to the board granted the second extension -- with the understanding the board would be addressing the complaint at its Thursday meeting.
However the board failed to put the issue on its agenda, and only changed it late Wednesday after the newspaper received a copy of Sclarsic’s letter and inquired about the issue.Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.