Massachusetts Pharmacy Board Now Accepting Nonresident Pharmacy License Applications Under New Licensing Regime

As of January 1, 2025, the Massachusetts Board of Registration in Pharmacy (the Board) is accepting applications for nonresident pharmacy licenses. Massachusetts law has mandated licensure of out-of-state pharmacies dispensing prescription drugs into Massachusetts since 2015; however, the Board did not promulgate regulations effectuating the licensure process until December 2024.

Following the Board’s promulgation of its long-awaited nonresident pharmacy licensing regime, pharmacies currently dispensing prescription drugs into Massachusetts must submit applications by March 31, 2025, to be considered timely. Any pharmacy that dispenses prescription drugs into the state without a license on or after May 1, 2025, will be subject to prosecution and penalties for unlawful distribution under Massachusetts law.

The Board’s new regime provides for licensure of nonresident drugstore (i.e., retail) pharmacies as well as both nonresident sterile and complex non-sterile compounding pharmacies. The Board stated it has no plans to offer nonresident licensure for non-dispensing pharmacies, wholesalers, distributors, third-party logistics providers (3PLs), or manufacturers.

The Massachusetts Pharmacy Application Checklist and link to the Health Professions Licensing Portal for submission of the application can be found on the Board’s website. We expect the Board to see a large volume of applications in advance of the deadline, so we recommend submitting applications as soon as possible to avoid delays.

Massachusetts’ new nonresident pharmacy regulatory regime imposes several other requirements prospective licensees should be mindful of.

Designated Pharmacist-in-Charge

At least one pharmacist at each nonresident pharmacy must hold a Massachusetts pharmacist license; however, this pharmacist does not need to be the Pharmacist-in-Charge with respect to the pharmacy’s resident state license. This “Designated Pharmacist-in-Charge” is responsible for assuring the pharmacy’s compliance with Massachusetts pharmacy laws and regulations.

The Board typically takes 30 to 60 days to process Massachusetts pharmacist licensure applications. Given the likely influx of applications, however, we recommend submitting any necessary pharmacist applications as soon as possible.

Controlled Substances Registration

Nonresident pharmacies must also obtain a Massachusetts Controlled Substances Registration to dispense controlled substances into Massachusetts. A Massachusetts Controlled Substances Registration will be required in virtually all cases because, under Massachusetts law, all prescription drugs, regardless of whether they are federally scheduled, are recognized as controlled substances.

The application for a Massachusetts Controlled Substances Registration is incorporated into the nonresident pharmacy licensure application process.

Reporting and Notification Requirements

• Change of ownership: Pharmacies must notify the Board of a proposed change of ownership at least 14 days before the change. The proposed new licensee must also submit a licensure application at least 14 days before the change.
• Name change: Pharmacies must notify the Board in writing within 14 days of any change in the name under which the pharmacy operates.
• Relocation: Pharmacies must submit an application for relocation to the Board at least 90 days before the intended relocation.
• Closure: Pharmacies must notify the Board in writing (by certified mail) at least 14 days before the intended closure. 
• Change of Designated Pharmacist-in-Charge: Pharmacies must notify the Board within 14 days of the resignation, termination, or change of its Designated Pharmacist-in-Charge and submit an application for approval of the change within 90 days. 
• Prescription monitoring program: Pharmacies must report to the Prescription Monitoring Program information for Schedules II-V and gabapentin prescriptions dispensed into Massachusetts.
• Improper dispensing: Pharmacies must report to the Board any improper dispensing of a prescription drug into Massachusetts that results in serious injury or death within seven days of discovery of the improper dispensing.
• Adverse actions: Pharmacies must report to the Board within 14 days of any disciplinary actions or adverse changes in accreditation status, and provide the Board with any inspection reports, investigation reports, and FDA warning letters received from local, state, or federal agencies.

Inspections

For initial licensure, each nonresident retail pharmacy must provide the Board a copy of its most recent inspection report conducted within two years of submission of the application. Inspections conducted by the pharmacy’s resident state inspector or a “Board-approved inspector” (i.e., Gates Healthcare Associates Inc. and the National Association of Boards of Pharmacy) are acceptable. For renewal, nonresident retail pharmacies must submit copies of all reports and correspondence pertaining to inspections by state or federal agencies.

Applicants for sterile compounding and complex non-sterile compounding pharmacy licenses must achieve a satisfactory Board inspection prior to the issuance of a license.

The Goodwin Healthcare team continues to track the implementation of the Massachusetts nonresident pharmacy licensing regime. Please contact any member of our team with questions.

 

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee similar outcomes.