Section R156-17b-614c - Operating Standards - Class B - Pharmaceutical Administration FacilityIn accordance with Subsections 58-17b-102(44) and 58-17b-601(1), the following operating standards apply to prescription drugs that are held, stored, or otherwise under the control of a pharmaceutical administration facility for administration to patients:
(1) The licensed consulting pharmacist shall provide consultation on each aspect of pharmacy services in the facility; establish a system of records of receipt and disposition of controlled substances in sufficient detail to enable an accurate reconciliation; and determine that drug records are in order and that an account of all controlled substances is maintained and periodically reconciled.(2) Authorized destruction of prescription drugs shall be witnessed by the medical or nursing director or a designated physician, registered nurse or other licensed person employed in the facility and the consulting pharmacist or licensed pharmacy technician, and shall be in compliance with 21 CFR 1317 (2021).(3) Prescriptions for patients in the facility may be verbally requested by a licensed prescribing practitioner and may be entered as the prescribing practitioner's order; but the practitioner must personally sign the order in the facility record within 72 hours if a Schedule II controlled substance and within 30 days if any other prescription drug. The prescribing practitioner's verbal order may be copied and forwarded to a pharmacy for dispensing and may serve as the pharmacy's record of the prescription order.(4) Prescriptions for controlled substances for patients in Class B pharmaceutical administration facilities shall be dispensed according to Title 58, Chapter 37, Utah Controlled Substances Act, and Rule R156-37, Utah Controlled Substances Act Rules. (5) Requirements for emergency drug kits shall include:(a) an emergency drug kit may be used by pharmaceutical administration facilities. The emergency drug kit shall be considered to be a physical extension of the pharmacy supplying the emergency drug kit and shall remain under the ownership of that pharmacy;(b) the contents and quantity of drugs and supplies in the emergency drug kit shall be determined by the Medical Director or Director of Nursing of the pharmaceutical administration facility and the consulting pharmacist of the supplying pharmacy;(c) a copy of the approved list of contents shall be conspicuously posted on or near the kit;(d) the emergency kit shall be used only for bona fide emergencies and only when medications cannot be obtained from a pharmacy in a timely manner;(e) records documenting the receipt and removal of drugs in the emergency kit shall be maintained by the facility and the pharmacy;(f) the pharmacy shall be responsible for ensuring proper storage, security and accountability of the emergency kit and shall ensure that: (i) the emergency kit is stored in a locked area and is locked itself; and(ii) emergency kit drugs are accessible only to licensed physicians, physician assistants and nurses employed by the facility;(g) the contents of the emergency kit, the approved list of contents and related records shall be made freely available and open for inspection to appropriate representatives of the Division and the Utah Department of Health.Utah Admin. Code R156-17b-614c
Amended by Utah State Bulletin Number 2022-03, effective 1/27/2022