By Matt Murphy
State House News Service
BOSTON -- The House on Monday advanced an oversight bill that would impose new licensing requirements, fines and inspection procedures upon the roughly 40 compounding pharmacies that operate in Massachusetts or compound drugs for in-state patients.
The bill, which was released by the Ways and Means Committee on Monday and advanced to set up a floor debate Wednesday, would also establish a reconfigured Board of Registration in Pharmacy, and order new regulations for the licensing of in-state and out-of-state pharmacies that distribute sterile compounded drugs in Massachusetts.
Almost a year ago, a Framingham drug manufacturer found itself at the center of a national public-health emergency, as tainted steroids linked to the New England Compounding Center were discovered to be the cause of an outbreak of fungal meningitis that claimed the lives of 61 around the country and infected hundreds more.
According to the Food and Drug Administration, pharmacy compounding is a practice "in which a licensed pharmacist combines, mixes, or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient." The FDA says pharmacy compounding "if done properly can serve an important public health need if a patient cannot be treated with an FDA-approved medication."
While touting the role that compounding pharmacies can play, the FDA says the "emergence of firms with pharmacy licenses making and distributing drugs in a way that's outside the bounds of traditional pharmacy compounding is of great concern."
The proposed legislation emerges as House leaders look to move beyond debates over the state budget and taxes to finance transportation investments that have dominated Beacon Hill during the first nine months of the year.
The 26-page bill, which has also been vetted this session by the Committees on Public Health and Health Care Financing, was reported out of the Ways and Means committee Monday morning, with 15 members voting in favor of the bill and three reserving their rights.
It will be presented to House Democrats during a caucus Wednesday before floor votes in the afternoon. The legislation proposes to alter the makeup of the Board of Registration in Pharmacy to include six pharmacists with varying specialties, one pharmacy technician, one representative of the public with health-care service delivery or advocacy experience, one physician and one expert in patient safety.
The board would be required to conduct inspections and random audits of compounding pharmacies in Massachusetts, and compounding pharmacies would be required to comply with new drug-labeling mandates, inventory reporting and mandated disclosure of "adverse drug events" to the Food and Drug Administration, which would include deaths, hospitalizations, birth defects or other negative impacts from the use of a drug.
In addition to establishing a new category of licenses for pharmacies that engage in sterile drug compounding, the board would be required under the bill to establish a procedure to license out-of-state pharmacies that prescribe, ship or dispense compounded medications in Massachusetts.
The licensing procedure of any state in which the pharmacy doing business in Massachusetts is located must be equivalent to the standards in Massachusetts, according to the bill.
Violations of the new rules and terms of license could result in fines of up to $25,000 against an offending pharmacy, and the board would be authorized to assess penalties of up to $1,000 a day if the violations are not corrected in a timely manner.
The commissioner of public health would also be required to maintain a free, publicly searchable website for enforcement actions against individual pharmacies or public-health risks associated with certain drugs.
The bill going before the House is similar to one Gov. Deval Patrick filed in January, and comes after the Department of Public Health moved to impose emergency regulations in the aftermath of the NECC scandal to improve oversight and patient safety with increased inspections.
Patrick replaced several members of the Board of Pharmacy, and inspectors began conducting spot-checks of other compounding pharmacies in the Massachusetts.
The Senate this month also passed legislation increasing the maximum penalty for corporate manslaughter to $250,000, from $1,000, with the NECC case and the 2006 Big Dig tunnel collapse serving as key motivating factors for lawmakers.