COMMONWEALTH OF MASSACHUSETTS
STATE HOUSE, BOSTON 02133-1053
Senator Joan B. Lovely
2nd Essex District
Phone: (617) 722-1410
Thursday, October 31, 2013
SENATE PASSES BILL TO REGULATE COMPOUNDING PHARMACIES
(Boston) To ensure patient safety and public health, the Senate on Wednesday passed legislation by a vote of 38-0 to increase regulatory oversight of compounding pharmacies in the Commonwealth through added enforcement powers and the creation of specialty pharmacy licenses. This bill follows a deadly outbreak of fungal meningitis that was traced to a drug compounded by the New England Compounding Center in Framingham.
“What happened in Framingham was a tragic error, and today’s legislation is about fixing the system that allowed that to happen,” commented Senator Joan Lovely (D-Essex). “This bill’s added regulations and enforcement provisions will fill a dangerous oversight gap that existed in the pharmacy industry.”
“The devastating meningitis outbreak harmed individuals and families across the country and it’s critical that we take the necessary steps in Massachusetts to evaluate our oversight and regulation policies regarding compounding pharmacies,” Senate President Therese Murray (D-Plymouth) said. “This bill provides stricter rules and practices to protect the public’s health and will help prevent a similar tragic situation from happening in the future.”
“This bill brings transparency and regulation to an evolving area of the pharmacy practice, and puts important safeguards in place that will ensure this industry moves in the right direction,” said Senator John F. Keenan (D-Quincy), Senate Chair of the Joint Committee on Public Health. “Pharmacy compounding fills an important health care need, but our lack of regulation over the industry thus far has allowed for egregious errors and harm to patients. We are taking steps to correct this, so that Massachusetts can continue forward as a national leader in every aspect of health policy.”
The bill establishes sterile compounding and complex non-sterile compounding specialty licenses to be issued by the Board of Registration of Pharmacy and requires inspectors to conduct both planned and unplanned inspections of licensed pharmacies.
Inspectors are required to be trained in sterile compounding and complex non-sterile compounding practices. The bill also doubles the required continuing education hours for pharmacists and requires training in sterile and complex non-sterile compounding for pharmacists working in those facilities.
For pharmacies located outside of the state that conduct business in Massachusetts, the bill creates an out-of-state pharmacy license and requires them to participate and comply with the Prescription Monitoring Program.
To expedite the discovery of unsafe drug conditions, this legislation requires stores and pharmacies to report any improper dispensing of prescription drugs that result in serious injury or death to the Department of Public Health and to report any serious adverse drug events that are the result of improper compounding or other pharmacist error to the Board.
The bill arms the Board with new enforcement powers, allowing the Board to assess penalties for pharmacy violations and suspend a pharmacy or pharmacist if there is a reasonable concern for the health, safety or well-being of the public.
In addition, the bill requires the Board to report any investigatory and disciplinary actions and a summary of all serious adverse drug events to the Department of Public Health, the Joint Committee on Public Health and the Joint Committee on Healthcare Financing.
In an effort to promote transparency between consumers and pharmacies, the bill creates a free searchable website that provides contact information for licensed pharmacies, records of enforcement and disciplinary actions and a database of all reported serious adverse drug events. Compounding pharmacies must also maintain a phone line 7 days and 56 hours per week.
The bill also does the following:
- Designates a manager of record to maintain records and ensure the pharmacy’s compliance with the law;
- Places compounding pharmacies under the “Marketing Code of Conduct,” that is currently required of manufacturers of pharmaceuticals and medical devices; and,
- Increases labeling requirements for compounded drugs, including a notification of whether the drug is a sterile or non-sterile compounded drug.
The Senate and the House bill, which passed October 2, will go to a conference committee to produce a compromise bill for final passage and consideration of the governor.