20 CSR 2220-2.090 - Pharmacist-in-Charge
PURPOSE: 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.
Notes
*Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.240, RSMo 1951; and 338.280, RSMo 1951, amended 1971, 1981.
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