20 CSR 2220-2.090 - Pharmacist-in-Charge
(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
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
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