(1) In order to be registered by the Board to manage and operate a pharmacy or pharmacy department and be issued a permit to do so, the registered pharmacist who shall be responsible for the management and operation of the pharmacy or pharmacy department shall obtain and submit to the Board an application for registration to manage and operate a pharmacy or pharmacy department available from the Board. A completed application shall be:
(a) fully and properly completed and signed, under the penalties of perjury, by the pharmacist who is to manage and operate the pharmacy or pharmacy department;
(b) accompanied by a statement of the scheduled hours during which the pharmacy or pharmacy department is to remain open, including the time of opening and closing during regular business hours for each day of the week;
(c) accompanied by an application, available from the Board, for a Massachusetts controlled substance registration;
(d) accompanied by an application, available from the Board, for a certificate of fitness, if applicable;
(e) accompanied by a check or money order made payable, in the proper amount, to the "Commonwealth of Massachusetts Board of Registration in Pharmacy"; and
(f) accompanied by any additional information as determined by the Board.
(2) A completed application to operate a pharmacy shall include:
(a) a copy of the corporation's Articles of Organization, signed and sealed by the Secretary of the Commonwealth if the corporation is incorporated in the Commonwealth;
(b) a copy of the corporation's Foreign Corporation Certificate, signed and sealed by the Secretary of the Commonwealth pursuant to M.G.L. c. 181, § 4, if the corporation in incorporated in another state;
(c) a statement of the name and address of each officer and director of the corporation and the position held;
(d) the d/b/a (doing business as) name of the corporation; and
(f) if the corporation is not publicly owned, the total amount and type of stock issued to each stockholder and the names and addresses of said stockholder(s).
(3) The Board shall not register nor permit ownership of a pharmacy or pharmacy department by a practitioner with prescriptive privileges.
(4) Before acting upon any application for registration to manage and operate a pharmacy or pharmacy department, the Board may require a hearing and, if requested to do so, the applicant shall personally appear before the Board to answer questions to enable the Board to determine that issuance of a permit would be in the best interests of the public health, welfare and safety as set forth in M.G.L. c. 112, § 39.
(5) The Board may require an inspection of the pharmacy or pharmacy department before final approval of the application is granted. All proposed pharmacies and pharmacy departments shall comply with the following requirements:
(a) No application for registration to manage and operate a pharmacy or pharmacy department shall be approved unless, upon inspection, the following is maintained on the pharmacy premises:
1. a current copy or electronic version of the Massachusetts List of Interchangeable Drugs (MLID), including the Orange Book, Additional List, Exception List;
2. a current copy or electronic version (with quarterly updates) of a compendia appropriate to the practice setting approved by the pharmacist manager of record.
3. a current copy or electronic version of the Board Regulations (247 CMR);
4. a balance capable of accurately weighing quantities as small as 13 milligrams, which balance shall be tested and sealed by the state or local sealer of weights and measures annually;
5. the equipment necessary to conduct the practice of pharmacy according to the standards set forth by most current edition of the United States Pharmacopoeia;
6. prescription labels which bear the name and address of the proposed pharmacy;
7. appropriate sanitary appliances, including a suitable sink which shall be equipped for hot and cold running water and which shall be situated in or near the area in which prescriptions are to be filled;
8. whenever applicable, at least one bound book for recording sales of controlled substances which may be sold over-the-counter without a prescription; and
9. whenever applicable, at least one book for recording sales of alcoholic beverages and signatures of the purchasers of these beverages.
(b) There shall be within every pharmacy or pharmacy department a prescription area of not less than 300 square feet to accommodate the appropriate pharmaceutical equipment, apparatus, and supplies, and to facilitate the proper preparation and compounding of prescribed medications. This area shall provide for an arrangement and storage of drugs that is calculated to prevent their accidental misuse.
(c) Any pharmacy or pharmacy department which establishes a central intravenous admixture service (CIVAS) or performs sterile compounding shall, in addition to the 300 square feet required by 247 CMR 6.01(5)(b), provide for a separate room referred to as a "clean room" apart from all other areas of the pharmacy or pharmacy department. The pharmacy shall obtain approval from the Board indicating compliance with 247 CMR 6.01 and
United States Pharmacopeia General Chapter 797 prior to initial operation of central intravenous admixture services or performance of any sterile compounding. The Board's approval shall be conspicuously posted and visible to the public, on the pharmacy premises. This clean room shall meet the following requirements:
1. There shall be a minimum working area of 72 square feet;
2. it shall be closed on all sides except for a door and an opening to allow for the passage of materials;
3. it shall have a laminar flow hood with either vertical or horizontal air flow;
4. the laminar flow hood standards of operation of HEPA (High Energy Particulate Air) filters and prefilters must be determined and certification shall be made annually by a Board-approved hood certification service;
5. the Board shall be notified before beginning operation of the clean room to verify hood certification;
6. the area of the clean room shall be under continual positive pressure unless the hood is self-venting; and
7. applications for construction of a pharmacy with a clean room received after September 30, 1996 shall show the clean room located directly adjacent to the prescription area/department.
(d)
Patient Consultation Area.
1. A pharmacy must provide a designated consultation area, with signage stating "Patient Consultation Area", designed to provide adequate privacy for confidential visual and auditory patient counseling. The private consultation area must be accessible by a patient from the outside of the prescription dispensing area without having to traverse a stockroom or the prescription dispensing area.
2.247 CMR 6.01(5)(d) shall be effective for all new or relocating pharmacies on April 1, 2005. All existing pharmacies must comply with 247 CMR 6.01(5)(d) by January 1, 2007.
(6) The Board shall issue a permit indicating the pharmacy or pharmacy department's registration number if the Board finds, in its reasonable discretion, that approving the application would be consistent with the best interest of public health, welfare and safety.
(7) All fees submitted to the Board in connection with an application for registration to operate a pharmacy or pharmacy department, which are reviewed and acted upon by the Board, are nonrefundable.
