R156-17b-617c. Class E Pharmacy Operating Standards - Animal Control or Animal Narcotic Detection Training  


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  •   (1) In accordance with Section 58-17b-302 and Subsection 58-17b-601(1), an animal control or animal narcotic detection training facility shall:

      (a) maintain for immediate retrieval a perpetual inventory of all drugs including controlled substances that are purchased, stored, processed and administered;

      (b) maintain for immediate retrieval a current list of authorized employees and their training with regards to the handling and use of legend drugs and/or controlled substances in relation to euthanasia, immobilization, or narcotic detection training of animals;

      (c) maintain, for immediate retrieval documentation of all required materials pertaining to legitimate animal scientific drug research, guidance policy and other relevant documentation from the agency's Institutional Review Board, if applicable;

      (d) maintain stocks of legend drugs and controlled substances to the smallest quantity needed for efficient operation to conduct animal euthanasia, immobilization, or narcotic detection training purposes;

      (e) maintain all legend drugs and controlled substances in an area within a building having perimeter security that limits access during working hours, provides adequate security after working hours, and has the following security controls:

      (i) a permanently secured safe or steel cabinet substantially constructed with self-closing and self-locking doors employing either multiple position combination or key lock type locking mechanisms; and

      (ii) requisite key control, combination limitations, and change procedures;

      (f) have a responsible party who is the only person authorized to purchase and reconcile legend drugs and controlled substances and is responsible for the inventory of the animal control or animal narcotic detection training facility pharmacy;

      (g) ensure that only defined and approved individuals pursuant to the written facility protocol have access to legend drugs and controlled substances; and

      (h) develop and maintain written policies and procedures for immediate retrieval that include the following:

      (i) the type of activity conducted with regards to legend drugs and/or controlled substances;

      (ii) how medications are purchased, inventoried, prepared and used in relation to euthanasia, immobilization, or narcotic detection training of animals;

      (iii) the type, form and quantity of legend drugs and/or controlled substances handled;

      (iv) the type of safe or equally secure enclosures or other storage system used for the storage and retrieval of legend drugs and/or controlled substances;

      (v) security measures in place to protect against theft or loss of legend drugs and controlled substances;

      (vi) adequate supervision of employees having access to manufacturing and storage areas;

      (vii) maintenance of records documenting the initial and ongoing training of authorized employees with regard to all applicable protocols;

      (viii) maintenance of records documenting all approved and trained authorized employees who may have access to the legend drugs and controlled substances; and

      (ix) procedures for allowing the presence of business guests, visitors, maintenance personnel, and non-employee service personnel.