To ensure patient safety, 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.
“The meningitis outbreak earlier this year was a terrible tragedy for individuals and families across the country. The strengthened oversight and regulatory systems we are putting into place today are important responses that will help us to avoid this type of problem in the future,” said Senator Karen Spilka, who represents Framingham. “Compounding pharmacies can provide useful medical options, but regulation is critically necessary to ensure that we are protecting the safety and health of all patients.”
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 bill and the House bill, which passed Oct. 2, will go to a conference committee to produce a compromise bill for final passage and consideration of the governor.