Okla. Admin. Code § 475:20-1-2

Current through Vol. 42, No. 4, November 1, 2024

Section 475:20-1-2 - General security requirements

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled dangerous substances. In order to determine whether a registrant has provided effective controls against diversion, the Director shall require adherence to the security requirements as set forth generally in the Uniform Controlled Dangerous Substances Act, and specifically by this Chapter, as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in 475:20-1-4 and 475:20-1-6 may be used in lieu of the materials and construction described in those Sections.

(b) Substantial compliance with the standards set forth in 475:20-1-3 through 475:20-1-7 may be deemed sufficient by the Director after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Director may consider any of the following factors as he/she may deem relevant to the need for strict compliance with security requirements:

(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.).

(2) The type and form of controlled dangerous substances handled (e.g., bulk liquids or dosage units, usable or non- usable powders).

(3) The quantity of controlled dangerous substances handled.

(4) The location of the premises and the relationship such location bears on security needs.

(5) The type of building construction comprising the facility and the general characteristics of the building(s).

(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used.

(7) The type of closures on vaults, safes and secure enclosures.

(8) The adequacy of key control systems and/or combination lock control systems.

(9) The adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources.

(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any.

(11) The adequacy of supervision over employees having access to manufacturing and storage areas.

(12) The procedures for handling business guests, visitors, maintenance personnel and non-employee service personnel.

(13) The availability of local police protection or of the registrant's or applicant's security personnel.

(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution and disposition of controlled dangerous substances in its operations.

(c) When physical security controls become inadequate as a result of a controlled dangerous substance being transferred to a different schedule, or as a result of a non-controlled dangerous substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled dangerous substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in 475:20-1-3 through 475:20-1-7 when the need for such controls, as determined by the Director, decreases as a result of a controlled dangerous substance being transferred to a different schedule, or as a result of a controlled dangerous substance being moved from control, or as a result of a significant decrease in the quantity of controlled dangerous substances in the possession of the registrant during normal business operations.

(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in 475:20-1-3 through 475:20-1-7, may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.

Okla. Admin. Code § 475:20-1-2