Current through Register 1531, September 27, 2024
Except as provided by exemptions set forth in 247 CMR 12.00: Restricted Pharmacy with respect to restricted pharmacies and 247 CMR 13.00: Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies with respect to nuclear pharmacies, the following conditions shall apply to the continuing operation of a pharmacy or pharmacy department:
(1) The premises of the pharmacy or pharmacy department shall at all times be kept in a clean and sanitary manner.
(2) The equipment and publications set forth in 247 CMR 6.01(5)(a) shall be maintained in the pharmacy or pharmacy department at all times.
(3) The following shall be conspicuously displayed within the pharmacy or pharmacy department:
(a) the pharmacy permit;
(b) the pharmacy's Massachusetts controlled substance registration;
(c) the pharmacy's U.S. Drug Enforcement Administration controlled substance registration; and
(d) whenever applicable, the pharmacy's certificate of fitness.
(4) The pharmacy or pharmacy department shall maintain on the premises at all times a sufficient variety and supply of medicinal chemicals and preparations which are necessary to compound and dispense commonly prescribed medications in accordance with the usual needs of the community.
(5) A pharmacy or pharmacy department shall have a reasonably-sized sign affixed to the main entrance of the business or otherwise installed in an easily observable area outside the premises, identifying the presence of a pharmacy or pharmacy department.
(6) A pharmacy or pharmacy department shall conform to the following security requirements:
(a) All controlled substances in Schedules II through V shall be stored within the prescription area;
(b) controlled substances in Schedule VI shall be stored within the prescription area or in the clean room if the clean room is directly adjacent to the prescription area;
(c) controlled substances in Schedules II, III, IV, and V shall be stored in a securely locked and substantially constructed cabinet, or dispersed in the prescription-drug storage area throughout the stock of Schedule VI controlled substances in such a manner as to obstruct the theft or diversion of these controlled substances;
(d) there shall be a separate working alarm for the pharmacy or pharmacy department which shall be activated when the pharmacy or pharmacy department is closed;
(e) a pharmacy department must be secured by a floor to ceiling barrier, securely locked and separately alarmed at all times when the pharmacy department is closed;
(f) the pharmacist Manager of Record and the pharmacist on duty shall be responsible for pharmacy security and shall control access to the prescription area;
(g) all drug order deliveries containing controlled substances shall be delivered directly to the pharmacy or pharmacy department or to a secured area if the pharmacy is closed, and the security of those controlled substances is the responsibility of the pharmacist Manager of Record; and
(h) each pharmacy or pharmacy department shall comply with all other security requirements which the Board may deem necessary for the protection of the public.
(7) A pharmacy or a pharmacy department shall conspicuously display, in legible letters not less than one inch high over, on or adjacent to the main entrance of the pharmacy or pharmacy department, the name of the pharmacist Manager of Record who is responsible for the management and operation of the pharmacy or pharmacy department.
(8) A pharmacy or pharmacy department shall meet the following requirements concerning the posting of hours of operation:
(a) The hours of operation shall be prominently posted at all consumer entrances to the pharmacy and, in the case of a pharmacy department, the hours shall also be posted at all consumer entrances to the retail store and at the pharmacy department;
(b) if the hours of operation of a pharmacy department, subject to the requirements of 247 CMR 6.02(6)(e) and (10), are different from those of the retail store in which it is located, all advertising referring to the pharmacy department shall clearly specify the pharmacy department's hours of operation; and
(c) if the hours of operation of a pharmacy's prescription area, subject to the requirements of 247 CMR 6.02(10), are different from the hours of operation for its non-prescription business, all advertising for the pharmacy shall clearly specify the hours of operation of the pharmacy's prescription area.
(9) A pharmacy or pharmacy department shall meet the following requirements concerning registered pharmacists on duty and shall be present at all times when non-pharmacist personal have unrestricted access to the pharmacy or pharmacy department:
(a) A registered pharmacist shall be on duty and on the pharmacy premises at all times the pharmacy or pharnacy department is open for business and shall be present at all times when non-pharmacist personal have unrestricted access to the pharmacy or pharmacy department;
(b) each registered pharmacist who is a full-time employee of the pharmacy shall have readily available, or displayed in a conspicuous place, his or her certificate of registration to practice pharmacy and the original or a copy of his or her current wallet registration card; and
(c) a registered pharmacist shall not remain on duty for more than 12 hours per day.
(10) A pharmacy or pharmacy department shall report a theft or loss of a significant amount of controlled substances by submitting to the Board a copy of " Report of Theft or Loss of Controlled Substance" (DEA BND Form 106), within seven days of such theft or significant loss and, where applicable, shall comply with the reporting requirements of the DEA, the Department and the state and local police.
