HAR §16-95-80. Physical presence of a registered pharmacist

(a) A registered pharmacist shall be physically present during the hours of operation of a prescription area. (b) At any time a registered pharmacist is not in the prescription area, (except in cases of emergencies), the entire stock of prescription drugs shall be §16-95-80 95-29 secured from access to unauthorized persons and the means of access shall only be in the control of the pharmacist. (c) A pharmacist in an institutional pharmacy shall ensure that written policies and procedures have been established by the institutional facility for providing drugs to the medical staff and other authorized personnel of the institutional facility by use of night cabinets, and access to the institutional pharmacy and emergency kits when the pharmacist is not in the area. A "night cabinet” is a cabinet, room, or any other enclosure not located within the prescription area. The written policies and procedures shall provide that a pharmacist shall be "on call" during those periods when night cabinets are utilized and shall provide policies and procedures regarding the following: (1) Security of the night cabinet to ensure that the night cabinet is sufficiently secured to deny access to unauthorized persons by force or otherwise; (2) The development and maintenance of an inventory listing of all drugs included in the cabinet and the requirement that the pharmacist ensures, at a minimum, that: (A) Drugs available therein are properly labeled; (B) Only prepackaged drugs are available therein in amounts sufficient for immediate therapeutic requirements; and (C) An appropriate practitioner's prescription regarding the dispensing of drugs exists; (3) Access to the pharmacy. In the event a drug is not available from floor supplies or night cabinets and the drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from the institutional pharmacy in accordance with this subsection. Authorized personnel may remove drugs therefrom provided: (A) The authorized personnel are designated, in writing, by the institutional facility; (B) The authorized personnel have been instructed by the pharmacist of the proper methods of access, and the records and procedures regarding removal of the drugs; and (C) The authorized personnel are required to complete a form which shall include the patient's name and room number, the name of drug, drug strength, dosage, quantity of drug removed, date, time, and the signature of the authorized personnel; and (4) The prompt detection, removal, disposal, handling, and replacement, if possible, of a drug that has been recalled by the §16-95-80 95-30 U.S. Food and Drug Administration or the manufacturer to ensure that recalled drugs are removed from the pharmacy's inventory, emergency kit, night cabinet, remote dispensing machine, or from the patient if deemed necessary according to the federal and manufacturer's guidelines. [Eff and comp 12/24/92; comp 12/25/04; am and comp 06/22/15; am and comp 8/15/16] (Auth: HRS §461-4.5) (Imp: HRS §§461-1, 461-4.5, 461-9, 461-10, 461-11, 461-12) Historical note: The substance of this section is based in part on section 16-95-4. [Eff 5/16/64; am and ren §16-95-4, 6/22/81; R 12/24/92]