- Board of Registration in Pharmacy
1. Is non-resident registration offered for 503B outsourcing facilities?
Yes. Regulatory information can be found here:
https://www.mass.gov/regulations/247-CMR-2100-registration-of-outsourcing-facilitie
2. Will non-resident licensure be offered for wholesalers, distributors, 3PLs, or manufacturers?
The Board has no plans to offer non-resident licensure for these facilities.
3. Is a Massachusetts pharmacy license required for out-of-state pharmacies at this time?
The Board does not currently issue licenses to non-resident pharmacies. A non-resident pharmacy may deliver or ship medications into Massachusetts as long as the pharmacy is licensed and in good standing in the state where it is located.
4. Will non-resident pharmacy licensure be offered in the future?
Yes, we will soon have regulations in place to require licensure. Consider e-mailing us at Pharmacy.admin@mass.gov and ask to be added to the email distribution list so you can be notified of when licensing becomes available.
5. Will the pharmacist-in-charge (PIC) need a Massachusetts pharmacist license?
Each non-resident pharmacy will be required to have a designated pharmacist hold a Massachusetts pharmacist license. This “Designated Pharmacist-in-Charge” is responsible for assuring non-resident pharmacy compliance with all Massachusetts laws and regulations pertaining to the practice of pharmacy. It is recommended to have more than one Massachusetts licensed pharmacist in the event that the Designated Pharmacist-in-Charge is no longer able to continue in this capacity.
6. Will an inspection of my pharmacy be required for licensure?
Yes. See pages 3-5 for acceptable inspections.
7. What does a non-resident pharmacy have to report?
Since non-resident pharmacies are not yet licensed, there is no need to report things such as change of PIC or address. However, information for Schedules II - V and gabapentin prescriptions that are delivered or shipped into Massachusetts must be reported to the Prescription Monitoring Program (PMP):
https://www.mass.gov/info-details/pharmacy-reporting-and-data-submission
Please direct any questions to: Pharmacy.Admin@mass.gov