Cal. BPC § 4113 — California Code / Code bpc / Division 2 / Chapter 9 / Article 7 / Section 4113
Section 4113
Status: in_force

(a) (1) Every pharmacy shall designate a pharmacist-in-charge.

(2) A pharmacy licensed pursuant to Section 4110 shall, within 30 days of the designation in paragraph (1), notify the board in writing of the identity and license number of that pharmacist and the date they were designated.

(3) A pharmacy licensed pursuant to Section 4112 shall, within 90 days of the designation in paragraph (1), notify the board in writing of the identify and license number of that pharmacist and the date they were designated.

(b) The proposed pharmacist-in-charge shall be subject to approval by the board. The board shall not issue or renew a pharmacy license without identification of an approved pharmacist-in-charge for the pharmacy.

(c) (1) The pharmacist-in-charge shall be responsible for a pharmacy’s compliance with all state and federal laws and regulations pertaining to the practice of pharmacy.

(2) The pharmacist-in-charge shall make staffing decisions to ensure sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with a pharmacist’s ability to practice competently and safely. If the pharmacist-in-charge is not available, a pharmacist on duty may adjust staffing according to workload if needed. This paragraph does not apply to facilities of the Department of Corrections and Rehabilitation.

(3) The determination of the appropriate pharmacist-to-technician ratio shall be made by the pharmacist-in-charge, provided that the ratio does not exceed the maximum ratio established in subdivision (g) of Section 4115. No other person, permittee, or licensee shall interfere with the exercise of the pharmacist-in-charge’s independent professional judgment in setting the pharmacist-to-technician ratio.

(d) (1) The pharmacist-in-charge or pharmacist on duty shall immediately notify store management or the building owner or a similar entity of any conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. Store management shall take immediate and reasonable steps to address and resolve the conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff. If the conditions are not resolved within 24 hours, the pharmacist-in-charge or pharmacist on duty shall ensure the board is timely notified.

(2) Nothing in this subdivision shall be construed as presenting, limiting, or restraining a pharmacist-in-charge, pharmacy technician, or member of the public from communication with the board, including filing a complaint.

(3) The conditions that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff may include, but are not limited to, any of the following:

(A) Workplace safety and health hazards that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.

(B) Sustained temperatures that could impact ambient temperature drug stability according to manufacturer data on acceptable drug storage conditions.

(C) Vermin infestation that poses a risk to the safety or efficacy of medicine.

(4) If, after receipt of a notice described in paragraph (1) and an evaluation and assessment of the relevant evidence, the executive officer has a reasonable belief that conditions within a pharmacy exist that present an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff, the executive officer may, in conformance with the processes set forth in subdivisions (b) and (c) of Section 4127.3, issue an order to the pharmacy to immediately cease and desist those pharmacy operations that are affected by the conditions at issue. The cease and desist order shall remain in effect until either the executive officer determines the conditions that presented an immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff have been abated or for no more than 30 days, whichever is earlier. Evidence of corrective actions taken shall be submitted by the pharmacy to correct the conditions at issue. Failure to comply with a cease and desist order issued pursuant to this section shall be unprofessional conduct pursuant to Section 4156.

(5) Nothing in this paragraph shall prevent the owner of the licensed premises from closing a pharmacy to mitigate against a perceived immediate risk of death, illness, or irreparable harm to patients, personnel, or pharmacy staff.

(6) Facilities of the Department of Corrections and Rehabilitation shall be exempt from this subdivision.

(e) (1) Every pharmacy licensed pursuant to Section 4110 shall notify the board in writing, on a form designed by the board, within 30 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge.

(2) Every pharmacy licensed pursuant to Section 4112 shall notify the board in writing, on a form designed by the board, within 90 days of the date when a pharmacist-in-charge ceases to act as the pharmacist-in-charge, and shall on the same form propose another pharmacist to take over as the pharmacist-in-charge.

(3) The proposed replacement pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board.

(f) If a pharmacy is unable, in the exercise of reasonable diligence, to identify within 30 days a permanent replacement pharmacist-in-charge to propose to the board on the notification form, the pharmacy may instead provide on that form the name of any pharmacist who is an employee, officer, or administrator of the pharmacy or the entity that owns the pharmacy and who is actively involved in the management of the pharmacy on a daily basis, to act as the interim pharmacist-in-charge for a period not to exceed 120 days. The pharmacy, or the entity that owns the pharmacy, shall be prepared during normal business hours to provide a representative of the board with the name of the interim pharmacist-in-charge with documentation of the active involvement of the interim pharmacist-in-charge in the daily management of the pharmacy, and with documentation of the pharmacy’s good faith efforts prior to naming the interim pharmacist-in-charge to obtain a permanent pharmacist-in-charge. By no later than 120 days following the identification of the interim pharmacist-in-charge, the pharmacy shall propose to the board the name of a pharmacist to serve as the permanent pharmacist-in-charge. The proposed permanent pharmacist-in-charge shall be subject to approval by the board. If disapproved, the pharmacy shall propose another replacement within 15 days of the date of disapproval, and shall continue to name proposed replacements until a pharmacist-in-charge is approved by the board.