247 CMR, § 6.10 - Change of Manager of Record for Resident Pharmacies

(1) A pharmacy shall submit a change of Manager of Record application to the Board for approval whenever there is a change of Manager of Record. The Board may require the proposed pharmacist Manager of Record to appear before the Board prior to approving or denying an application.

(2) A licensee, or duly authorized representative of the licensee, and the proposed new Manager of Record shall sign an application for change of Manager of Record. A change of Manager of Record application shall include:

(a) an attestation confirming the pharmacy performed an inventory of all controlled substances in Schedules II through V and controlled substances in Schedule VI required to be reported to the prescription monitoring program and filed the inventory report with the pharmacy's controlled substance records. The attestation shall be signed by the outgoing Manager of Record and the proposed incoming Manager of Record. In the event the outgoing Manager of Record is unavailable due to death, serious illness, or termination, a staff pharmacist may be authorized to sign the inventory report, provided the Board is notified at the time the application is submitted the reason the staff pharmacist is signing the inventory report;

(b) the original Drug Store Pharmacy license;

(c) required fee(s); and

(d) any additional information, as required by the Board.

(3) In its discretion, the Board may determine a proposed Manager of Record is not suitable to manage a pharmacy, and that it would not be in the interest of public health, safety, and welfare to approve the application for a change of Manager of Record. In making its determination, the Board may consider the following factors:

(a) A proposed Manager of Record acted in a manner that presented an immediate or serious threat to public health and safety.

(b) A proposed Manager of Record prevented or attempted to impede the work of any duly authorized representative of the Board or the Department or the lawful enforcement of any provision of M.G.L. c. 112, M.G.L. c. 94C, or regulations promulgated thereunder.

(c) A proposed Manager of Record owned, operated, held an interest in, or managed a pharmacy, healthcare facility, or other entity registered by the FDA or the DEA, that was the subject of proceedings resulting in the discipline, suspension, denial, or revocation of the pharmacy license or other professional license or registration.

(d) A proposed Manager of Record owned, operated, held an interest in, or managed a pharmacy, healthcare facility, or other entity registered by the FDA or the DEA, that entered into a consent agreement in resolution of a complaint against a pharmacy or other entity registered by the FDA or DEA resulting in disciplinary action against the pharmacy license or other professional license or registration.

(e) A proposed Manager of Record owned, operated, held an interest in, or managed a pharmacy, healthcare facility, or other entity registered by the FDA or the DEA, in such a manner that created an immediate or serious threat to public health and safety.

(f) A proposed Manager of Record failed to demonstrate that he or she has the competence or experience to manage a pharmacy.

(g) A proposed Manager of Record obtained or attempted to obtain a license by fraud or misrepresentation, including the submission of false information.

(h) A proposed Manager of Record has been disciplined by the Board within five years of the date of the application.

(i) A proposed Manager of Record held a professional license or registration that was the subject of proceedings resulting in the discipline, suspension, denial, or revocation of the license or registration.

(j) A proposed Manager of Record entered into a consent agreement in resolution of a complaint against a professional license or registration resulting in disciplinary action against the professional license or registration.

Notes

247 CMR, § 6.10

Amended by Mass Register Issue 1536, eff. 12/6/2024.