Mo. Code Regs. tit. 20 § 2220-2.090
Current through Register Vol. 49, No. 17, September 3, 2024
Section 20 CSR 2220-2.090 - Pharmacist-in-ChargePURPOSE: This amendment updates compliance requirements and responsibilities for the designated pharmacist-in-charge of a board licensed pharmacy.
(1) Except as otherwise authorized by law, each pharmacy shall designate a pharmacist-in-charge who is responsible for managing pharmacy compliance and supervising pharmacy staff. At a minimum, the pharmacist-in-charge shall assist the permit holder in ensuring pharmacy operations and clinical activities comply with the rules of the board and all applicable state and federal law governing pharmacy practice.(A) The pharmacist-in-charge must be regularly involved in, and engaged with, pharmacy operations and monitoring pharmacy compliance. Except in the event of an emergency or other urgent need, the pharmacist-in-charge must be consulted and given an opportunity to provide input prior to implementation of any pharmacy policy, procedure, system, or practice that will modify or expand the delivery of pharmacy services.(B) The pharmacist-in-charge must be physically present at the pharmacy for a sufficient amount of time as needed to effectively supervise pharmacy activities and ensure pharmacy compliance. Additionally, the permit holder must provide the pharmacist-in-charge designated time to review pharmacy compliance on a regular basis while not engaged in medication dispensing or providing patient services.(C) The pharmacist-in-charge must have authority to temporarily suspend or restrict pharmacy operations or the activity of licensees/registrants, if deemed reasonably necessary or appropriate to ensure pharmacy compliance or the safe provision of pharmacy services, pending final direction or approval from the permit holder.(D) The permit holder must have policies and procedures in place for regularly reviewing staffing and resource needs with the pharmacist-in-charge, including policies and procedures for requesting additional staff or staffing modifications.(2) A pharmacist must immediately notify the board electronically or in writing on a form designated by the board if he/she stops serving as the designated pharmacist-in-charge. At or immediately prior to a pharmacist-in-charge change, a controlled substance inventory must be taken by a designee of the permit holder that complies with state and federal controlled substance inventory requirements, including 21 CFR section 1304.11. The signature of the individual(s) taking the required inventory must be documented on the inventory.(3) This rule does not exempt a permit holder from responsibility for compliance with applicable state or federal law. AUTHORITY: sections 338.140, 338.240 and 338.280, RSMo 2000.* This rule originally filed as 4 CSR 220-2.090. Emergency rule filed April 12, 1984, effective April 22, 1984, expired Aug. 20, 1984. Original rule filed April 12, 1984, effective Aug. 11 , 1984. Amended: Filed Feb. 25, 1986, effective Aug. 11 , 1986. Amended: Filed Jan. 27, 1995, effective Sept. 30, 1995. Amended: Filed Aug. 21, 1998, effective Feb. 28, 1999. Amended: Filed Dec. 30, 1998, effective June 30, 1999. Amended: Filed Nov. 1, 2000, effective June 30, 2001. Moved to 20 CSR 2220-2.090, effective Aug. 28, 2006. Amended by Missouri Register July 15, 2022/Volume 47, Number 14, effective 8/31/2022*Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.240, RSMo 1951; and 338.280, RSMo 1951, amended 1971, 1981.