California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 2 - Pharmacies
Section 1715.65 - Inventory Activities and Inventory Reconciliation Reports of Controlled Substances
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) Every pharmacy, and every clinic licensed under sections 4180 or 4190 of the Business and Professions Code, shall perform periodic inventory activities and prepare inventory reconciliation reports to detect and prevent the loss of federal controlled substances. Except as provided in subdivisions (f) and (g), inventory reconciliation reports shall be prepared on the following ongoing basis:
(b) The pharmacist-in-charge of a pharmacy or consulting pharmacist for a clinic shall review all inventory activities performed and inventory reconciliation reports prepared pursuant to this section, and establish and maintain secure methods to prevent losses of federal controlled substances. Written policies and procedures shall be developed for performing the inventory activities and preparing the inventory reconciliation reports required by this section.
(c) An inventory reconciliation report prepared pursuant to this section shall include all of the following:
(d) A pharmacy or clinic shall report in writing identified losses and known causes to the board within 30 days of discovery unless the cause of the loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovery. If the pharmacy or clinic is unable to identify the cause of the loss, further investigation shall be undertaken to identify the cause and actions necessary to prevent additional losses of federal controlled substances.
(e)
(f) A new pharmacist-in-charge of a pharmacy shall complete an inventory reconciliation report for all federal controlled substances described in paragraphs (1) and (2) of subdivision (a) within 30 days of becoming pharmacist-in-charge. Whenever possible, an outgoing pharmacist-in-charge should also complete an inventory reconciliation report for those controlled substances.
(g) Notwithstanding the periodic reporting requirements specified in paragraphs (1) and (2) of subdivision (a), inpatient hospital pharmacies shall prepare an inventory reconciliation report or reports covering the federal controlled substances described in paragraphs (1) and (2) of subdivision (a) on a quarterly basis. The report or reports shall include controlled substances stored within the pharmacy, within each pharmacy satellite location, and within each drug storage area in the hospital under the pharmacy's control.
(h) If an inpatient hospital pharmacy or licensed correctional pharmacy uses an automated drug delivery system (ADDS), inventory in the ADDS may be accounted for under subdivision (c)(1) using means other than a physical count.
1. New section
filed 1-25-2018; operative 4-1-2018 (Register 2018, No. 4).
2.
Amendment of section heading, section and NOTE filed 7-20-2022; operative
1-1-2023 (Register 2022, No. 29).
Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4008, 4037, 4080, 4081, 4101, 4104, 4105, 4110, 4113, 4180, 4181, 4182, 4186, 4190, 4191, 4192 and 4332, Business and Professions Code; and Section 1261.6, Health and Safety Code.