Section 1715.65 - Inventory Activities and Inventory Reconciliation Reports of Controlled Substances(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:(1) For federal Schedule II controlled substances, at least once every three months.(2) For products containing the following substances in the following strengths per tablet, capsule, other unit, or specified volume, at least once every 12 months: (A) Alprazolam, 1 milligram/unit.(B) Alprazolam, 2 milligrams/unit.(C) Tramadol, 50 milligrams/unit.(D) Promethazine/codeine, 6.25 milligrams of promethazine and 10 milligrams of codeine per 5 milliliters of product.(3)(A) For any controlled substance not covered by paragraph (1) or (2), an inventory reconciliation report shall be prepared for identified controlled substances lost no later than three months after discovery of the reportable loss of that controlled substance. This report shall be completed if the loss is discovered either by the inventory activities required by subparagraph (B), or in any other manner. The report shall cover the period from the last physical count of that controlled substance before the loss was discovered through the date of discovery. At a minimum, a reportable loss is as specified in section 1715.6, or any pattern(s) of loss(es) identified by the pharmacist in charge, as defined by the pharmacy's policies and procedures. A reportable loss shall require an inventory reconciliation report for each pattern of loss identified.(B) Inventory activities for each controlled substance not covered by paragraph (1) or (2) shall be performed at least once every two years from the performance of the last inventory activities. For purposes of this section, "inventory activities" means inventory and all other functions sufficient to identify loss of controlled substances. The functions sufficient to identify loss outside of the inventory reconciliation process shall be identified within the pharmacy's policies and procedures.(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:(1) A physical count, not an estimate, of all quantities of each federal controlled substance covered by the report that the pharmacy or clinic has in inventory, except as provided in subdivision (h). The biennial inventory of controlled substances required by federal law may serve as one of the mandated inventories under this section in the year where the federal biennial inventory is performed, provided the biennial inventory was taken no more than three months from the last inventory required by this section. An individual who performs the inventory required by this paragraph shall sign and date the inventory or the report in which it is included as provided in subdivision (e)(1);(2) A review of all acquisitions and dispositions of each federal controlled substance covered by the report since the last inventory reconciliation report covering that controlled substance;(3) A comparison of (1) and (2) to determine if there are any variances;(4) Identification of all records used to compile the report, which shall be maintained in the pharmacy or clinic pursuant to subdivision (e)(2);(5) Identification of each individual involved in preparing the report; and(6) Possible causes of overages.(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)(1) An inventory reconciliation report shall be dated and signed by the pharmacist-in-charge or professional director (if a clinic), in addition to any signature required by subdivision (c)(1). An individual may use a digital or electronic signature or biometric identifier in lieu of a physical signature under this section if, in addition, the individual physically signs a printed statement confirming the accuracy of the inventory or report. The signature shall be dated, and the signed and dated statement shall be retained on file pursuant to paragraph (2).(2) The report, and all records used to compile the report, shall be readily retrievable in the pharmacy or clinic for three years.(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.Cal. Code Regs. Tit. 16, § 1715.65
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.
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. 31).