Pharmacy Operation

(1) A pharmacy shall maintain the following on the pharmacy premises: (a) a current copy or electronic version of the Massachusetts List of Interchangeable Drugs, including the Orange Book, Additional List, Exception List; (b) a current copy or access to electronic version with quarterly updates of a compendia appropriate to the practice setting approved by the pharmacist manager of record; (c) a current copy or access to electronic version of laws and regulations governing the practice of pharmacy, including, M.G.L. c. 94C, M.G.L. c. 112, §§ 24 through 42A, 105 CMR 700.000: Implementation of M.G.L. c. 94C, 105 CMR 720.00: List of Interchangeable Drug Products, and 105 CMR 721.00: Standards for Prescription Format and Security in Massachusetts , and 247 CMR 2.00 through 21.00; (d) a current copy or access to electronic version of Plumb's Veterinary Drug Handbook or other veterinary reference approved by the Board; (e) a balance capable of accurately weighing quantities as small as ten milligrams, which shall be tested and sealed by the state or local sealer of weights and measures at least once each calendar year. All new balances shall have "legal for trade" designation; (f) the equipment, supplies, and medications necessary to conduct the practice of pharmacy in accordance with the usual needs of the community and scope of practice of the pharmacy; (g) the equipment necessary to perform simple and moderate non-sterile compounding; (h) policies and procedures to ensure supplies, tools, utensils, and equipment are used and maintained in a manner that avoids cross contamination and ensures proper functioning; (i) a potable water supply in or near the prescription area in order to wash hands and equipment. The sink shall have hot and cold water, soap or detergent, and single use towels; and (j) a designated compounding area for simple and moderate non-sterile compounding. (2) A pharmacy that obtained its Drug Store pharmacy license on or after July 1, 2020 shall have a prescription area that is at least 325 square feet. (3) A pharmacy shall ensure the accuracy and performance of electronic counting machines for solid dosage forms and other electronic measuring devices. (4) The prescription area shall provide for the arrangement and storage of drugs, supplies, and equipment in a manner that is calculated to prevent accidental misuse, cross contamination, and error. (5) A pharmacy shall store medications in the manufacturer's stock bottles or in other stock containers that are clearly labeled with the product name, strength or concentration, NDC number, manufacturer or supplier, lot number, assigned expiration date, and date that the medication was transferred out of its original stock bottle. (6) A pharmacy shall be clean and sanitary and in good repair at all times. (7) Pharmacy equipment shall be clean and sanitary and in good repair at all times. (8) A pharmacy in Massachusetts shall conspicuously display within the pharmacy: (a) the pharmacy's Massachusetts Drug Store pharmacy license; (b) other pharmacy license issued by the Board, as applicable; (c) the pharmacy's Massachusetts controlled substance registration; and (d) the pharmacy's U.S. Drug Enforcement Administration registration. A non-resident pharmacy shall maintain the documents identified in 247 CMR 9.19(8) in a readily retrievable manner. (9) As applicable, a pharmacy shall post on the wall or maintain the following in readily retrievable location: (a) immunization certifications and current CPR card for each pharmacist and pharmacy intern that perform immunizations; (b) current power of attorney ("POA") forms required for DEA 222 forms, as applicable; (c) Collaborative Drug Therapy Management Agreements; (d) written finding from the Board waiving any Board regulations; and (e) standing orders, if any. (10) A pharmacy shall have a sign affixed to each customer entrance that is easily observable from the outside and clearly identifies the presence of a pharmacy. (11) A pharmacy shall conspicuously display, in legible letters not less than one inch high, over, on, or adjacent to the main entrance of the pharmacy, the name of the pharmacist Manager of Record. (12) A pharmacy shall effectuate a recall of medication that is or may be defective in any way. (13) A pharmacy shall obtain and record consent from a patient or patient's agent prior to enrolling that patient in an automatic refill program. A pharmacy shall provide a method for patients to discontinue participation in an automatic refill program. (14) A pharmacy 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 located within a retail establishment, the hours shall also be posted at all consumer entrances to the retail store and at the pharmacy; and (b) if the hours of operation of a pharmacy located within another retail establishment are different from those of the retail establishment, all advertising referring to the pharmacyshall clearly specify the pharmacy's hours of operation. (15) A pharmacy shall maintain a written continuity of care plan that describes the manner in which patient needs will be met in the event the pharmacy is unexpectedly unable to provide pharmacy services. The pharmacy shall notify the Board if pharmacy operations are unexpectedly suspended for more than 24 hours. (16) Registered Pharmacists on Duty. (a) Unless otherwise permitted by law or regulation, a licensed pharmacist shall be on the pharmacy premises at all times the pharmacy is open for business and shall be present at all times when non-pharmacist personnel have unrestricted access to the pharmacy. (b) While on duty, a pharmacist shall: 1. ensure compliance with supervisory ratios in accordance with 247 CMR 8.06: Duties of Pharmacist Utilizing Pharmacy Interns, Certified Pharmacy Technicians, Pharmacy Technicians, and Pharmacy Technician Trainees; 2. maintain proper storage and security of controlled substances; 3. report problems with sanitary conditions or repair to Manager of Record; 4. limit access to all pharmacy areas to authorized personnel; 5. be familiar with applicable Board approved audit tool(s); and 6. have access to all pharmacy records and be able to provide requested records to Board investigators. (17) Temporary Absence of a Pharmacist. (a) In any pharmacy that is staffed by a single pharmacist, the pharmacist may leave the pharmacy prescription area temporarily for necessary and appropriate breaks and meal periods without closing the pharmacy or removing ancillary staff from the pharmacy if the pharmacist reasonably believes that the securityof the controlled substances and devices will be maintained in his or her absence. A pharmacist must remain on the pharmacy premises, but is not required to remain in the prescription area. A temporary absence shall not exceed 30 minutes per six hours. (b) During a pharmacist's temporary absence, a pharmacy may not provide any prescription medication to a patient or a patient's agent unless the prescription is a refill medication that the pharmacist has checked and determined not to require the consultation of a pharmacist prior to being released to the patient. A new prescription which has been previously prepared, visibly checked by a pharmacist, and had a drug utilization performed by a pharmacist, may be picked up by a patient provided that a log, including the patient's phone number, of all such transactions is kept. The pharmacist upon return from break and within a reasonable time shall call the patient to review any pertinent counseling deemed appropriate. (c) During a pharmacist's temporary absence, the pharmacy technical support staff may continue to perform the non-discretionary duties. However, any duty performed by any member of the ancillary staff shall be reviewed by a pharmacist upon his or her return to the pharmacy. (d) In pharmacies where there are two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the pharmacy is not left without a pharmacist for a temporary period. (e) A pharmacy shall maintain written policies and procedures regarding the operation of the pharmacy during the temporary absence of a pharmacist. (18) Upon commencement of the employment of a registered pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician in training, the pharmacy shall verify that the individual's license to practice is current. (19) A pharmacy shall store and dispose of waste in a sanitary and timely manner. (20) A pharmacy shall maintain an e-Profile Number from the National Association of Boards of Pharmacy ("NABP") or other national database, as required by the Board. A pharmacy shall perform a self-inspection within seven days of any renovation, expansion, relocation, or change of Manager of Record, and at least one time per year, utilizing a Board-approved inspection tool for routine compliance, sterile compounding, and non-sterile compounding, as applicable. The pharmacy shall retain the completed self-inspection tool for at least two years. A pharmacy shall maintain a readily accessible policy and procedure for computer downtime which shall include: (a) a process for filling prescriptions during downtime; (b) a process for ensuring prescriptions dispensed during computer downtime are duly recorded in the patient's medication profile of the computerized pharmacy system when it becomes operational; (c) continuity of care, if necessary; and (d) process for performing an appropriate drug utilization review. (23) The requirements of 247 CMR 9.19(1)(e), (1)(j), (2), (9), (10), (11), (14), (16), and (17) do not apply to non-resident pharmacies. (24) The requirements of 247 CMR 9.19(1)(a), (1)(d), (1)(e), (1)(g), (1)(j), (8), (11), and (20) do not apply to institutional sterile compounding pharmacies.