Current through Register 1536, December 6, 2024
Section 6.04 - General Application Requirements(1) An application for a Drug Store Pharmacy license, sterile compounding pharmacy license, complex non-sterile compounding pharmacy license, institutional sterile compounding pharmacy license, non-resident Drug Store Pharmacy license, non-resident sterile compounding pharmacy license, and non-resident complex non-sterile compounding pharmacy license shall be made on forms prescribed by, and available from, the Board.(2) In support of an application for a license to operate a Drug Store Pharmacy, sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, non-resident Drug Store Pharmacy, non-resident sterile compounding pharmacy, and non-resident complex non-sterile compounding pharmacy, the applicant shall submit: (a) complete application forms, signed by: 1. the proposed Massachusetts licensed pharmacist Manager of Record or, in the case of a non-resident pharmacy, the designated Massachusetts licensed pharmacist in charge; and2. each applicant or an individual authorized to sign on behalf of the applicant(s);(b) a statement of the scheduled hours during which the pharmacy is to remain open;(c) a complete application, available from the Board, for a Massachusetts controlled substance registration or a copy of an existing Massachusetts controlled substance registration;(d) payment of a non-refundable licensing and application fee as determined by the Executive Office of Administration and Finance;(e) blueprints or equivalent architectural drawings depicting the pharmacy layout;(f) any request(s) for waiver(s) of Board regulation(s); and(g) any additional information, as required by the Board.(3) The Board may require the applicant(s), interest holder(s), the proposed Manager of Record, and any other person as required by the Board to personally appear before the Board to answer questions to facilitate the Board's determination whether issuance of a pharmacy license would not be in the best interest of public health, safety, and welfare.(4) The Board may require an inspection of a pharmacy before granting final approval of an application.(5) The Board may refuse to issue a pharmacy license if the Board finds, in its reasonable discretion, the applicant(s) and any interest holder(s) are not suitable and approving the application would not be in the best interest of public health, welfare, and safety.(6) All fees submitted to the Board in connection with an application for a pharmacy license are nonrefundable.(7) A pharmacy shall open within one calendar year of the Board's approval of its application or obtain written permission from the Board to open more than one calendar year after the Board's approval of the application.(8) A pharmacy license shall be non-transferrable.(9) Renewal of a Drug Store Pharmacy, sterile compounding pharmacy, complex non-sterile compounding pharmacy, institutional sterile compounding pharmacy, non-resident Drug Store Pharmacy, non-resident sterile compounding pharmacy, and non-resident complex non-sterile compounding pharmacy licenses and controlled substance registrations(a) Application for renewal of a pharmacy license and controlled substance registration shall be made by a duly authorized representative of the pharmacy in the form and manner determined by the Board. A renewal application form shall be fully and properly completed and submitted to the Board in a timely manner.(b) A licensee shall submit payment of a non-refundable licensing and application fee as determined by the Executive Office of Administration and Finance.(c) Each renewal application shall be accompanied by an attestation that the pharmacy complied with all mandatory reporting during that licensing period in accordance with 247 CMR 20.00: Reporting.(d) The Board may renew a pharmacy license and controlled substance registration if the Board finds, in its reasonable discretion, the licensee(s) and any interest holder(s) are suitable and approving the application would be consistent with the best interest of public health, welfare, and safety.Amended by Mass Register Issue 1536, eff. 12/6/2024.