Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in December 2024.[1] The regulatory changes concern non-resident (out-of-state) pharmacies, sterile and complex non-sterile compounding pharmacies, and all institutional sterile compounding pharmacies in Massachusetts.
The regulatory changes apply to new pharmacy applicants, but also apply to existing pharmacies. Existing pharmacy operators will now need to ensure that they obtain proper licensure from the Board and should be aware of the following key dates:
- The Board began accepting license applications – January 1, 2025
- License applications are due – March 31, 2025
- Deadline for obtaining licensure approval – May 1, 2025
Any non-resident pharmacy or in-state compounding pharmacy that wishes to continue dispensing prescription products in Massachusetts will need to obtain licensure from the Board no later than May 1, 2025 or it will need to cease operations. Per Board guidance, failure to comply may result in penalties, including prosecution.[2]
Hospital and Clinic Institutional Pharmacies
Hospitals and clinics that operate their own on-site pharmacies for their patients will be subject to the Board’s new regulations to the extent that they perform sterile compounding. Prior to these regulatory changes, such institutional sterile compounding pharmacies were subject only to review and approval by the Department of Public Health (“DPH”). Going forward, however, there will now be instances where approvals must be obtained from both DPH and the Board. A DPH-licensed hospital or clinic undertaking a construction or renovation project that includes a new institutional sterile compounding pharmacy or clean room unit will continue to need to apply for architectural Plan Review approval and licensure survey approval from DPH in compliance with existing DPH regulations. Separately and in addition, the facility will also need to apply for and obtain an institutional sterile compounding pharmacy license from the Board, which may include onsite surveys as well. Likewise, the same dual-agency licensure requirements will apply to a renovation project that results in expanding or otherwise changing the “footprint” of an existing institutional sterile compounding pharmacy or clean room. If, however, a renovation to an existing licensed unit stays within the unit’s current footprint, it is expected that the Board’s survey and approval will be needed based on information provided by DPH at this time. Nevertheless, as regulatory jurisdictional matters may continue to evolve, parties may still need to communicate with authorities at both agencies to ensure transparency and so that regulators have the opportunity to evaluate particular circumstances affecting the licensed clinical space and coordinate any necessary review activities.
It is important to note that these new Board regulations for institutional pharmacies apply only to sterile compounding. Institutional pharmacies at hospitals and clinics that do not perform compounding will continue to be subject to licensure and regulatory oversight by DPH only at present.
Verrill continues to monitor this new regulatory blueprint for further developments.
