W. Va. Code R. § 15-1-16

Current through Register Vol. XLI, No. 50, December 13, 2024
Section 15-1-16 - Duties and Responsibilities of the Pharmacist-in-Charge
16.1. A pharmacy may not operate without a pharmacist-in-charge (hereinafter "PIC"), who shall be designated on the application for a pharmacy license, and in each license renewal. A pharmacist may not serve as PIC unless he or she is physically present in the pharmacy a sufficient amount of time to provide supervision and control. A pharmacist may not serve as PIC for more than one pharmacy at any one time; Provided that, he or she may volunteer as the pharmacist-in-charge at a charitable clinic pharmacy while serving as a PIC in another pharmacy.
16.2. The pharmacist-in-charge has the following responsibilities:
16.2.1. The pharmacist-in-charge shall be responsible for the practice of pharmacy, as defined in this rule, at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacy permit holder shall be responsible for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice;
16.2.2. The pharmacist-in-charge shall document and notify the pharmacy permit holder of potential violations of any statute, rule or court order existing within the pharmacy. The PIC shall provide the permit holder verbal or electronic mail communication of any violations. Documentation shall be kept on file at the pharmacy. If appropriate action has not been taken within a reasonable amount of time the pharmacist-in-charge shall provide the pharmacy permit holder written notification of the violation(s) and a copy shall be retained in the pharmacy. If appropriate action has not been taken or significant progress achieved within a reasonable amount of time the pharmacist-in-charge shall provide a written notice to the permit holder with a copy submitted to the Chief Compliance Officer at the Board. No pharmacist-in-charge shall be sanctioned by the Board for any violation of any statute, rule or court order if they have previously given documented notice to the pharmacy permit holder as outlined in this section. The pharmacy permit holder shall be responsible for such violations. Nothing precludes the pharmacist-in-charge from immediately notifying the Board of any violations;
16.2.3. Implementing quality assurance programs for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. Quality assurance programs shall be designed to prevent and detect drug diversion;
16.2.4. The PIC shall implement and maintain a Pharmacy Technician Training Manual for the specific practice setting of which he or she is in charge. He or she shall supervise a training program conducted pursuant to the training manual for all individuals employed by the pharmacy who will assist in the practice of pharmacy. The PIC shall maintain a record of all technicians successfully completing the pharmacy's technician training program and shall attest to the Board, in a timely manner, those persons who, from time to time, have met the training requirements necessary for registration with the Board;
16.2.5. Implementing policies and procedures for the procurement, storage, security, and disposition of drugs and devices;
16.2.6. Assuring that all pharmacists and pharmacy interns employed at the pharmacy are currently licensed and that all pharmacy technicians employed at the pharmacy are currently registered with the board;
16.2.7. Notifying the board immediately of any of the following changes:
16.2.7.a. Change of employment or responsibility as the PIC;
16.2.7.b. Change of ownership of the pharmacy;
16.2.7.c. Change of address of the pharmacy;
16.2.7.d. Permanent closing of the pharmacy which shall be accompanied with a statement of the location where records will be retained for the required time period; or
16.2.7.e. The separation of employment of any pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee for any confirmed drug-related reason, including but not limited to, adulteration, abuse, theft, or diversion.
16.2.7.f. Notification shall include the reason for the termination. If it is the employment of the Pharmacist-in-Charge that is terminated, the owner and/or pharmacy permit holder shall immediately notify the Board of Pharmacy.
16.2.8. Making or filing any reports required by state or federal laws, rules, and regulations;
16.2.9. Responding to the board regarding any warning notice issued by the Board. The Board shall provide notification of the issuance of the warning notice to the pharmacy permit holder;
16.2.10. Implementing policies and procedures for maintaining the integrity and confidentiality of prescription information and patient health care information, or verifying their existence and ensuring that all employees of the pharmacy read, sign, and comply with the established policies and procedures; and
16.2.11. Providing the board with prior written notice of the installation or removal of an Automated Pharmacy System. The notice shall include, but is not limited to:
16.2.11.a. The name and address of the pharmacy;
16.2.11.b. The location of the automated equipment; and
16.2.11.c. The identification of the responsible pharmacist.
16.3. The PIC shall be assisted by a sufficient number of pharmacists and pharmacy technicians as may be required to competently and safely provide pharmacy services.
16.3.1. The PIC shall maintain and file with the Board, on a form provided by the Board, a current list of all pharmacy technicians assisting in the provision of pharmacy services.
16.3.2. The PIC shall implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall specify that pharmacy technicians are to be personally and directly supervised by a pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of pharmacy technicians, and that pharmacy technicians are not assigned duties that may be performed only by a pharmacist.

W. Va. Code R. § 15-1-16