Kan. Admin. Regs. § 68-20-15a

Current through Register Vol. 43, No. 50, December 12, 2024

Section 68-20-15a - Security requirements

(a) General security requirements. Each applicant and registrant shall provide effective controls and procedures to guard against theft and diversion of controlled substances in conformance with the security requirements of federal law, including the requirements of 21 CFR 1301.71 as in effect on April 1, 1999, which are hereby adopted by reference.

(b) Physical security controls for nonpractitioners shall comply with the requirements of 21 CFR 1301.72 and 1301.73 as in effect on April 1, 1999, which are hereby adopted by reference.

(c) Other security controls for nonpractitioners.

(1) Good faith inquiry. Before distributing a controlled substance to any person whom the registrant does not know to be registered to possess a controlled substance, each registrant shall make a good faith inquiry with the board to determine that the person is registered to possess a controlled substance.

(2) Suspicious orders. Each registrant shall design an operative system to disclose to the registrant any suspicious orders of controlled substances. Each registrant shall inform the board of suspicious orders when discovered. Suspicious orders shall include orders of unusual size, orders deviating from a normal pattern, and orders of unusual frequency.

(3) A controlled substance listed in schedules II through V shall not be distributed on a gratuitous basis by a manufacturer or distributor to a practitioner, mid-level practitioner, pharmacist, or any other person.

(d) Physical security controls for prescribers. Each prescriber shall provide effective controls and procedures to guard against theft and diversion of controlled substances in conformance with the security requirements of federal law, including the requirements of 21 CFR 1301.75 and 1301.76 as in effect on April 1, 1999, which are hereby adopted by reference.

(e) Other security controls for prescribers.

(1) In order to minimize the opportunities for diversion of controlled substances, each prescriber shall provide effective physical security, shall initiate additional procedures to reduce access by unauthorized personnel, and shall provide an alarm system if necessary.

(2) Minimum security standards for prescribers as set forth in this article shall be considered as guidelines to be used in evaluating security. Additional security controls and operating procedures may be required by the board to prevent diversion of controlled substances.

Kan. Admin. Regs. § 68-20-15a

Authorized by K.S.A. 1998 Supp. 65-4102; implementing K.S.A. 65-4117; effective May 1, 1983; amended May 1, 1988; amended Sept. 9, 1991; amended March 20, 1995; amended Aug. 1, 1997; amended Feb. 5, 1999; amended Dec. 27, 1999.