Massachusetts to Begin Licensing Nonresident Pharmacies and In-State Compounding Pharmacies

The Massachusetts Board of Pharmacy (Board) announced in September 2024 that it would soon require licensure for all nonresident pharmacies to dispense prescriptions, including sterile and nonsterile compounded products, to patients within the Commonwealth. (See Holland & Knight's previous alert, "Massachusetts Board of Pharmacy to Take a Big Step: Licensing Nonresident Pharmacies," Sept. 18, 2024.) On Nov. 19, 2024, the Board published an update to its previous announcement rolling out its implementation plan. The regulatory changes address additional categories of pharmacies and will directly impact nonresident pharmacies, all in-state and nonresident sterile and complex nonsterile compounding pharmacies, and all Massachusetts-based institutional sterile compounding pharmacies.¹ Notably, the Board released the following key dates and deadlines for nonresident and compounding pharmacies doing business in Massachusetts:

• The implementing regulations requiring licensure will be finalized in December 2024.²
• The Board expects to begin accepting license applications commencing on Jan. 1, 2025.
• The grace period for pharmacies to apply for a license ends on March 31, 2025.
• Any nonresident pharmacy or in-state compounding pharmacy without a license that dispenses prescription products into Massachusetts on or after May 1, 2025, will need to cease operations or be subject to prosecution and penalties.

What's Next?

Nonresident and compounding pharmacies should take the following steps to prepare for the licensing process:

1. Nonresident pharmacies should review the Board’s Non-Resident Pharmacy Licensure FAQs and continue to monitor for regulatory developments over the next month.
2. All compounding pharmacies, whether located inside or outside of Massachusetts or as part of an institution, should prepare to apply for licensure on or after Jan. 1, 2025, and prior to March 31, 2025. Given the anticipated influx of applicants, pharmacies should submit a complete application as early as possible.
3. Each nonresident pharmacy must have at least one pharmacist licensed in Massachusetts who serves as the "Designated Pharmacist-in-Charge" (PIC) responsible for compliance with Massachusetts pharmacy laws and regulations. Nonresident pharmacies and their pharmacists should commence the pharmacist licensing process as soon as possible. The Board previously estimated that processing for pharmacist licenses could take 30 to 60 days.
4. As part of the application, nonresident pharmacies must submit an inspection report that complies with the Non-Resident Pharmacy Inspection Requirements found on pages 3 to 5 of the FAQs. To avoid potential delays, applicants should confirm the date of their most recent inspection and verify that it was issued by a Massachusetts "Board-approved Inspector."
5. In-state institutional sterile compounding pharmacies will be contacted by an inspector upon the Board’s review of an application. Such pharmacies should review the requirements outlined by the Board and begin gathering the required information in preparation.

For nonresident and compounding pharmacies, the implications of these changes are far-reaching. If your organization operates in Massachusetts or plans to expand into the Commonwealth, compliance with these new licensure requirements will be essential to maintaining your operations and providing uninterrupted service to patients.

Holland & Knight will continue to monitor for new developments as this new Massachusetts regulatory framework unfolds. For more information, please contact the authors.

Notes

¹ "Institutional Sterile Compounding Pharmacy" is defined to include "any sterile compounding pharmacy located within a healthcare facility (including, but not limited to, hospitals, health maintenance organizations and clinics) that holds either a Hospital or Clinic MCSR (Massachusetts Controlled Substances Registration). "See MASS. BD. OF REGISTRATION IN PHARMACY, BUREAU OF HEALTH CARE SAFETY AND QUALITY, INSTITUTIONAL STERILE COMPOUNDING PHARMACY LICENSURE—HOSP. AND CLINIC 1 (2024). The Board will now require a distinct license for each unique Hospital or Clinic MCSR (i.e., each different physical address) as well as any sterile compounding pharmacy area(s) under the same MCSR.

² See Licensure of Pharmacies, 247 C.M.R. 6.00 (proposed December 2024) (to be codified at 247 C.M.R. 6.00, et seq.).

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.