Massachusetts Board of Registration in Pharmacy Works to Fortify Compounding Regulations

December 20, 2012 04:00 PM Topics: Compounding and Patient Safety

The Massachusetts Board of Registration in Pharmacy is considering eight potential solutions for improving the state’s regulation of pharmacy compounding. The solutions are part of the Board’s efforts to streamline compounding rules and improve patient safety. The Board outlined the following proposed solutions and the purpose behind them: 

1. Revise current laws to clearly differentiate manufacturing pharmacies from compounding pharmacies. One problem discovered at the New England Compounding Center (NECC), which was responsible for the deadly meningitis outbreak, was that it operated as a manufacturing pharmacy but did not adhere to the Food and Drug Administration’s (FDA) Good Manufacturing Practices, as it was classified as a compounding pharmacy.
2. Create a new license specifically for sterile compounding pharmacies. Separating compounding facilities from other pharmacies will assist in determining compliance and oversight.
3. Require accreditation for sterile compounding pharmacies. Nationally recognized accreditation elevates the level of scrutiny this specialized practice needs.
4. Conduct regular, unannounced site visits. All pharmacies in Massachusetts would be subject to routine inspections to ensure proper levels of oversight.
5. Provide inspector training. Workforce training for inspectors should be established to ensure that sterile compounding facilities operate under United States Pharmacopeia (USP) guidelines.
6. Create a sterile compounding survey tool. An evidence-based survey tool would be established to assist the boards of pharmacy and other regulatory agencies in assessing pharmacies’ compliance with USP standards in regard to sterile compounding.
7. Require random testing of high-risk sterile compounding. Revise laws to mandate random testing of all high-risk compounded sterile drug products. Current law requires testing only of batches with quantities greater than 25.
8. Create a crisis intervention team. Instruct the state department of public health to form a crisis intervention response team to assist regulatory bodies during emergencies. 

These eight solutions build upon emergency regulations that the Board approved in early November to differentiate between manufacturing and compounding pharmacies.