Current through Register Vol. XLI, No. 24, June 14, 2024
Section 15-2-5 - Security Requirements5.1. Security requirements.5.1.1. A registrant shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Board shall evaluate the overall security system and needs of the applicant or registrant.5.1.2. Physical security controls shall be commensurate with the schedules and quantity of controlled substances in the possession of the registrant in normal business operations. If a controlled substance is transferred to a different schedule or a noncontrolled substance is listed on any schedule, or the quantity of controlled substances in the possession of the registrant in normal business operations significantly increases, physical security controls shall be expanded and extended accordingly.5.1.3. A registrant who receives or transfers substantial quantities of controlled substances in normal business operations shall employ security procedures to guard against in-transit losses.5.2. Before distributing a controlled substance to a person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Board or with the appropriate state controlled substances registration agency, if any, to determine that the person is registered to possess the controlled substance.5.3. A wholesale drug distributor shall design and operate a system to disclose to the wholesale drug distributor suspicious orders of controlled substances. A wholesale drug distributor shall inform the Office of the Board on the Board supplied form_of suspicious orders of controlled substances when discovered by the wholesale drug distributor by providing a copy of the information which the wholesale drug distributor provides to the U.S. Drug Enforcement Administration regarding such suspicious orders. The notification shall include the contact information for the wholesale drug distributor's department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing, including electronic or internet based means, to the Office of the Board. If a wholesale distributor detects no suspicious orders in a calendar month, then the wholesale drug distributor shall inform the Office of the Board in writing within fifteen days of the end of such month stating it is reporting no suspicious orders for that month. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. The Board supplied form is available at www.wvbop.com. 5.3.1. A wholesale drug distributor that ceases distribution of Schedule II through V controlled substances to a customer located in West Virginia due to concerns that the customer may be involved in dispensing controlled substances for other than a legitimate medical purpose shall notify the Office of the Board within 5 days of the cessation. The notification shall include the contact information for the wholesale drug distributor's department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing to the Office of the Board.5.3.2. A wholesale drug distributor that decides not to commence distribution of Schedule II through V controlled substances to a customer in West Virginia due to a concern that the customer may be involved in dispensing controlled substances for other than a legitimate medical purpose shall notify the Office of the Board within 5 days of that decision. The notification shall include the contact information for the wholesale drug distributor's department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing to the Office of the Board.5.4. The registrant shall notify the Office of the Board of any theft or significant loss of any controlled substances upon discovery of the theft or loss as provided in subsection 9.3.5.5. Physical security controls5.5.1. When a pharmacy is closed, controlled substances listed in Schedule II shall be stored in a securely locked narcotic cabinet made of 20 gauge metal or better or may be dispersed throughout the stock of noncontrolled substances in a manner as to obstruct the theft or diversion of the controlled substance. Any other method of storage of controlled substances listed in Schedule II is not allowed unless specifically approved by the Board for that particular pharmacy. Only pharmacists practicing at the pharmacy and authorized by the pharmacist-in-charge may possess any keys or combinations to the narcotic cabinet. Controlled substances listed in Schedule III, IV, or V may be stored in the narcotic cabinet or may be dispersed throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substance. A secure automated distribution system, approved by the Board, may contain controlled substances within an institutional setting in lieu of a narcotic cabinet.5.5.2. The registrant shall not employ as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration denied, or had his or her registration revoked.