Mass. lawmakers unveil compounding pharmacy billBy STEVE LeBLANC , Associated Press
Jul. 9, 2013 1:44 PM ET
BOSTON (AP) — Beacon Hill lawmakers have unveiled a bill they say will tighten regulations on the state's compounding pharmacies in the wake of a fatal nationwide meningitis outbreak linked to a Massachusetts pharmacy.
The Public Health Committee approved the measure Tuesday. Supporters say it will modernize oversight by mandating unannounced inspections of compounding pharmacies and requiring them to report their drug production by type and volume.
The bill also incorporates proposals by Gov. Deval Patrick to create specialty licenses for all in-state and out-of-state sterile compounding pharmacies and create whistleblower protections for pharmacy workers.
The industry has come under scrutiny after a fungal meningitis outbreak traced to tainted steroids produced at the now-shuttered New England Compounding Pharmacy in Framingham killed 61 people and sickened more than 749 others.
Inspections last September found unsanitary conditions at the company's facility.
Rep. Jeffrey Sanchez, co-chairman of the committee, said the goal of the bill is to ensure "high standards in quality control and sterility" at the pharmacies.
"These are achievable standards, and standards they must meet in order to prevent another tragedy," said Sanchez, D-Boston.
The bill is also intended to improve communication between prescribers, pharmacies, regulators and the public. Part of that communication includes the requirement that the pharmacies provide a telephone hotline for patients.
Sanchez said the bill also recognizes the role that specialty compounding pharmacies play in filling in the "grey area" of modern health care.
Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors.
They have traditionally been overseen by state boards of pharmacy. But those bodies have struggled to police larger compounding operations that have emerged in recent years, producing medications in bulk and shipping them across state lines.
The New England Compounding Center shipped more than 17,600 doses of the pain injection implicated in the case.
In November, Massachusetts began requiring the pharmacies to report the volume and distribution of their medications to state regulators for the first time.
Patrick said at the time that the new rule was intended to help alert the state when a pharmacy like NECC is acting more like a manufacturer and should obtain a license from the federal Food and Drug Administration.
Patrick also ordered state regulators to begin unannounced inspections last fall. Previously, pharmacies were inspected only when they opened, relocated or were the subject of complaints.
In December, those inspections led to actions against three compounding pharmacies.
Sanchez said the bill would ensure that the unannounced inspections continue after Patrick leaves office.
The bill unveiled Tuesday would also:
— Require pharmacies and clinicians to report serious adverse drug events to state agencies and the FDA;
— Create a database to inform the public of pharmacies or pharmaceutical preparation associated with serious adverse events;
— Mandate the state to track all sterilely compounded drugs made by state-licensed pharmacies;
— Require compounded drugs be clearly labeled.
Eric Kastango, a member of Patrick's Task Force on Compounding, said in a statement that the bill "will serve as a national model ensuring patient safety and of the robust oversight of the compounding practices."
Deaths and injuries linked to the New England Compounding Pharmacy have been reported in 20 states, according to the federal Centers for Disease Control and Prevention. There have been no deaths or injuries in Massachusetts.
The bill now heads to the full House and Senate.