3 Colo. Code Regs. § 719-1-7.00.00
Current through Register Vol. 48, No. 1, January 10, 2025
Section 3 CCR 719-1-7.00.00 - PHARMACIST MANAGER RESPONSIBILITIES7.00.10 Reporting Violations. The pharmacist manager of a prescription drug outlet shall report to the Board, in writing, within the timelines set forth below: a. Diversion, theft or significant unaccountable loss of prescription drugs or controlled substances from the pharmacy, hospital or health maintenance organization (as defined in section 10-16-102, C.R.S.) within one business day of a substantiated loss. When a Drug Enforcement Administration (DEA) Form 106 is submitted to the DEA in instances involving controlled substances, a copy of the completed DEA Form 106 along with a detailed written explanation shall be submitted to the Board within one business day of signing the form. When determining whether an unaccountable loss is significant, the pharmacist manager shall consider, among others factors, the following: (1) The actual quantity of drug lost in relation to the type of business;(2) The specific drug lost;(3) Whether the loss of the drug can be associated with access to those drugs by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the drug;(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses;(5) Whether the specific drug is a likely candidate for diversion; and(6) Local trends and other indicators of the diversion potential of the missing drug.b. Security breaches within the pharmacy or pharmacy area of the establishment within ten days of discovery.c. Any pharmacist working in the pharmacy who is impaired due to the use of alcohol or drugs, or a pharmacist with a mental or physical impairment which affects his ability to perform his job competently. In such instance the report shall be submitted to the Board immediately upon discovery.d. Significant errors related to the practice of pharmacy, including those related to compounding, such as those that result in serious personal injury or death of a patient. In such instance the report shall be submitted to the Board immediately upon discovery.7.00.20 Administrative Reporting Responsibilities: a. A pharmacist manager shall immediately notify the Board in writing of the date he ceases to be the pharmacist manager of a prescription drug outlet.b. Upon the change of pharmacist manager of a prescription drug outlet, the new pharmacist manager or the new pharmacist manager's designee shall take an inventory of all controlled substances within seventy-two hours. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.c. Upon the transfer of ownership of a prescription drug outlet, the pharmacist manager or the pharmacist manager's designee shall take an inventory of all controlled substances. The inventory shall be taken either as of the opening or as of the close of business activity on the inventory date and such time and date taken shall be entered on the inventory record.d. The pharmacist manager shall determine or approve procedures for prescriptions delivered or temporarily stored outside the confines of a compounding/dispensing area at the request of a patient or an agent of the patient. This procedure shall include the storage of, security of, the access to, the confidentiality of, and the counseling regarding, prescriptions and necessary record keeping.e. Upon the closure of a prescription drug outlet it shall be the responsibility of the last pharmacist manager of record to remove the prescription and/or chart orders to another prescription drug outlet where patrons and/or practitioners are afforded reasonable access to a pharmacist's interpretation of such orders.f. The daily printout shall contain all information as required by rule. This applies to both prescription order and chart order dispensing.g. It is the responsibility of the pharmacist manager to ensure that all prescription drug outlet staff are aware that they must be able to print a report of all prescription order or chart order transactions for such period of time as the Board or its inspector(s) may specify, or to provide a computer terminal and monitor for the sole use of the Board or its inspector(s) to inspect and review dispensing transactions, and, if necessary, provide a person to assist the Board or its inspector(s) for a period of time not to exceed two hours in operating the system. (If the prescription drug outlet elects to comply with the latter requirement of providing equipment and/or personnel, the system must also be capable of printing the reports previously described.) Any failure or refusal by the pharmacist manager and/or a staff pharmacist to comply with a request by the Board or its inspector(s) will be deemed to be a willful violation of these Rules.h. It is the responsibility of the pharmacist manager to maintain records as required by Rule 11.00.00.I. It is the responsibility of the pharmacist manager to maintain records of initial interpretation and final evaluation as required by Rule 3.00.51(a) and (b).J. It is the responsibility of the pharmacist manager to maintain and to assure the outlet's compliance with a policy and procedure manual, where applicable, encompassing all aspects of non-sterile and sterile compounding as required by Rules 21.10.10 and 21.20.30, respectively. The annual review of such manual or manuals shall be signed and dated by the pharmacist manager. In the event the pharmacist manager changes, the new manager shall review, sign, and date the manual within thirty days of becoming the pharmacist manager.7.00.30 Compliance of Outlet: a. The manager of a prescription drug outlet is responsible for the operation of the outlet in compliance with all state and federal laws, rules, and regulations.b. Except as provided in sections 12-280-103(54)(b)(III) and 25.5-2.5-201 through 25.5-2.5-208, C.R.S., the pharmacist manager is responsible for ensuring that all prescription drugs and controlled substances are procured by the outlet from an entity or person registered by the Board. Any drug designated as an Investigational New Drug from the Federal Food and Drug Administration is exempt from this requirement provided the research requirements for the receipt of the product are followed and it meets the requirements of section 12-280-131(2), C.R.S.37 CR 18, September 25, 2014, effective 10/15/201438 CR 16, August 25, 2015, effective 9/14/201539 CR 04, February 25, 2016, effective 3/16/201639 CR 19, October 10, 2016, effective 11/14/201640 CR 04, February 25, 2017, effective 3/17/201740 CR 20, October 25, 2017, effective 11/14/201741 CR 16, August 25, 2018, effective 9/17/201842 CR 21, November 10, 2019, effective 11/30/201943 CR 10, May 25, 2020, effective 5/1/202043 CR 08, April 25, 2020, effective 5/15/202043 CR 15, August 10, 2020, effective 8/30/202043 CR 20, October 25, 2020, effective 11/14/202044 CR 04, February 25, 2021, effective 3/17/202144 CR 08, April 25, 2021, effective 5/15/202144 CR 21, November 10, 2021, effective 11/30/202145 CR 20, October 25, 2022, effective 9/29/202245 CR 21, November 10, 2022, effective 11/30/202246 CR 21, November 10, 2023, effective 11/30/2023