Santa Claus Brings Long-Awaited Regulatory Changes to Massachusetts Pharmacy Licensing | Polsinelli

After nearly a decade of waiting, Massachusetts has announced it will open the licensing process for non-resident dispensaries. Yesterday, the Massachusetts Board of Registration in Pharmacy released a memo announcing that regulations related to the licensing of non-resident pharmacies will be adopted in December 2024 and that the Board will begin accepting applications beginning January 1, 2025. The board has set an application deadline of March 31, 2025. After May 1, 2025, every pharmacy dispensing in Massachusetts must be licensed.

Nonresident pharmacies currently serving patients in Massachusetts will be impacted by these new licensing requirements and must take action now. To apply for a non-Massachusetts pharmacy license, each pharmacy must have at least one pharmacist (who does not have to be the pharmacist in charge) who has an individual Massachusetts pharmacist license. Typically, the pharmacist licensing process takes between 30 and 60 days. We anticipate that the Massachusetts Board will experience an influx of applications from pharmacists related to this change and the approval process may take significantly longer. There will also be inspection-related requirements based on the type of pharmacy services offered (compounding, sterile, non-sterile).

Important dates:

• December 2024: New regulations implementing the license for non-resident pharmacies.
• January 1, 2025: The board begins accepting applications.
• January 1, 2025 – March 31, 2025: Applications are accepted and considered timely.
• May 1, 2025: Enforcement begins for unlicensed pharmacies dispensing prescription products in Massachusetts.

Important requirements:

• Non-resident pharmacist license: At least one pharmacist in each licensed foreign pharmacy must have a Massachusetts pharmacy license. This pharmacist does not have to be the pharmacist responsible for the pharmacy.
• Inspections: When initially licensed, a non-resident pharmacy must provide an inspection conducted within 2 years of the date of application. The inspection must be conducted by a resident state inspector using the NABP Universal Inspection Form, the General Pharmacy Inspection, a resident state inspector using the state of residence’s General Pharmacy Compliance Inspection Form, OR by a board-certified inspector. Currently, NABP and Gates Healthcare Associates are licensed by the Massachusetts Board of Registration in Pharmacy.
• PMP reporting: Nonresident pharmacies must report Schedule II-V controlled substance prescriptions and gabapentin prescriptions dispensed in Massachusetts to the state Prescription Monitoring Program.
• Responsible pharmacist: Each nonresident pharmacy must designate a responsible pharmacist, and any changes in the responsible pharmacist must be reported within 14 calendar days of the change.

The board noted that there are no plans to issue licenses for non-dispensing pharmacies, wholesalers, distributors, 3PLs or manufacturers to non-residents.

Polsinelli will continue to monitor updates to pharmacy regulations in Massachusetts.