Are You Ready for Massachusetts Non-Resident Pharmacy Licensure?
On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for implementation. Because the applicant must identify a Massachusetts-licensed pharmacist to serve as pharmacist-in-charge for the purposes of the license, pharmacies seeking the non-resident license that don’t already have one on staff should identify a pharmacist immediately so he or she may apply for a Massachusetts pharmacist license. Relevant information and dates include the following:
New Licensure Requirements
- All non-resident pharmacies shipping into Massachusetts must obtain a license from the Board to dispense prescriptions into the state.1 Non-dispensing pharmacies will not be required to apply for licensure. The Board also clarified that it does not intend to offer non-resident licensure to wholesalers, distributors, 3PLs, or manufacturers.
- All resident and non-resident retail pharmacies engaging in sterile and complex non-sterile compounding will require additional licensure to compound and dispense any sterile or complex non-sterile compounded preparations.2
- All resident institutional pharmacies engaging in sterile compounding will require additional licensure.3 For purposes of this license, the Board defines an institutional sterile compounding pharmacy as “any sterile compounding pharmacy located within a healthcare facility including, but not limited to hospital, health maintenance organizations, and clinics) that holds either a Hospital or Clinic MCSR (Massachusetts Controlled Substances Registration).”
Timing
- The Board will begin accepting applications for these new pharmacy licenses on January 1, 2025.
- For pharmacies currently shipping into Massachusetts, the Board has established a grace period extending through March 31, 2025, to allow for these facilities to apply for new licensure.
- After May 1, 2025, all non-resident pharmacies shipping into Massachusetts must hold a license.
Additional Considerations
- For non-resident pharmacies, at least one pharmacist will have to be licensed in Massachusetts.4 While the Massachusetts-licensed pharmacist does not have to be the pharmacy’s pharmacist-in-charge, for purposes of licensure in Massachusetts this individual will be considered the “Designated Pharmacist-in-Charge” and will be responsible for the non-resident pharmacy’s compliance with Massachusetts laws and regulations.5 The Board typically allocates 30-60 days to process applications for pharmacist licensure. Given this timeline and the previously identified deadlines, non-resident pharmacies that do not currently employ a pharmacist licensed in Massachusetts should immediately begin to consider this requirement and complete the pharmacist licensure process as soon as possible.
- An inspection will be required for any non-resident pharmacy seeking licensure. The good news is that for retail pharmacies a home state inspection within two years of the application date is likely sufficient since Massachusetts will accept an inspection done by a resident state inspector using the state’s general pharmacy inspection form. Additional inspection criteria and Board-approved inspectors are identified on pages 3 to 5 of the Board’s Non-Resident Pharmacy Licensure FAQ.6 For institutional sterile compounding pharmacies, initial on-site inspections will be conducted following the Board’s review of the application. Applicable inspection requirements are outlined in the Institutional Sterile Compounding Pharmacy Licensure FAQ.7
- Newly licensed non-resident pharmacies should be prepared to comply with various reporting requirements in 247 CMR 20.00, found here.
Due to the relatively imminent deadlines, pharmacies shipping into Massachusetts should begin to consider the applicability of these new requirements and what steps can be taken to ensure compliance. Because of the potentially substantial implications for pharmacies, we will continue to monitor the Board and provide further updates as needed. If you have any additional questions related to these new licensure requirements, reach out to your contact at Quarles or:
- Jake Pallotta: 317-399-2810 / jake.pallotta@quarles.com
- Kaytie Ravega: 317-399-2849 / kaytie.ravega@quarles.com
- Susan Trujillo: 602-229-5318 / susan.trujillo@quarles.com
END NOTES
1 Non-Resident Pharmacy Licensure, Massachusetts Board of Registration in Pharmacy, available here.
2 Sterile and Complex Non-Sterile Compounding Licensure, Massachusetts Board of Registration in Pharmacy, available here.
3 Institutional Sterile Compounding Pharmacy Licensure – Hospital and Clinic, Massachusetts Board of Registration in Pharmacy, available here.
4 See Non-Resident Pharmacy Licensure.
5 Id.
6 See id. at (3)-(5).
7 See Institutional Sterile Compounding Pharmacy Licensure.