Nev. Admin. Code § 639.Sec. 1.9

Current through November 8, 2024
Section 639.Sec. 1.9 - NEW
1. Except as otherwise provided in this section, one or more dispensing practitioners practicing at a reproductive healthcare center may use an automated drug dispensing system and maintain a shared inventory in the automated drug dispensing system to dispense a prescription drug to a patient if the reproductive healthcare center obtains a license from the Board for the automated drug dispensing system pursuant to subsection 2.
2. The Board will provide an application for a license for an automated drug dispensing system to a reproductive healthcare center upon request. The Board will issue a license for an automated drug dispensing system if the Board determines that the system dispenses prescription drugs accurately and otherwise meets the requirements of this section and the fee prescribed by NAC 639.220 is paid. A license must be:
(a) Issued for each automated drug dispensing system at a reproductive healthcare center; and
(b) Posted on the system so that the license is visible to the public.
3. The automated drug dispensing system must conform to all the following provisions:
(a) Except as otherwise provided in subsection 8, the system must contain only dangerous drugs, excluding compound drug products, for treatment in reproductive health care:
(1) Approved for use in the system by a dispensing practitioner; and
(2) For which the prescription has been processed, verified and completed in the same manner as a prescription for drugs that are delivered manually by a dispensing practitioner pursuant to NAC 639.742 and 639.745, except that the requirements of paragraph (e) of subsection 3 of NAC 639.742 do not apply.
(b) The system must:
(1) Control and track access to the system for stocking, cleaning, maintenance or any other purpose to ensure that access to the system can be obtained only by a dispensing practitioner practicing at the reproductive healthcare center.
(2) Be secure from unauthorized access to and removal of prescription drugs.
(3) Be owned or leased by the reproductive healthcare center that obtained the license for the system and operated under the supervision and control of that reproductive healthcare center.
(4) Monitor the temperature of the system or be able to have a device installed to monitor the temperature of the system. Such monitoring must include, without limitation, an alarm that records when the temperature of the system reaches a level outside the range compatible with the proper storage of a prescription drug and a method to notify the reproductive healthcare center of the temperature change.
(5) Create and maintain a complete, accurate and readily retrievable record of all transactions. The record must include, without limitation:
(I) The name, strength, quantity and form of dosage of each prescription drug stocked, inventoried, removed or dispensed from the system;
(II) Each day and time the system is accessed;
(III) An inventory of the prescription drugs stored in the system; and
(IV) The identity of each person who accesses the system.
(6) Authorize access only to patients who have previously indicated to the dispensing practitioner who prescribed the drug their desire to have their prescription drugs dispensed by the system.
(7) Provide a method to identify the patient and dispense a prescription drug only to the patient or to an authorized agent of the patient.
(8) Dispense one, any combination or all of the prescription drugs available to a patient at the option of the patient at the time that the patient removes the prescription drugs from the system.
(9) Record the date and time that the patient removes the prescription drugs from the system.
(10) Inform a patient:
(I) If the patient is using the system at the time that the reproductive healthcare center is open, that the patient may discuss questions and concerns regarding the prescription drug with the dispensing practitioner in person, if available, or through user-based access technology described in subparagraph (13).
(II) If the patient is using the system at the time that the reproductive healthcare center is closed, that the patient may discuss questions and concerns regarding the prescription drug through the user-based access technology described in subparagraph (13).
(III) That the patient may choose not to purchase the prescription drug from the system at any time before the system dispenses the prescription drug.
(11) Dispense all prescription drugs in containers labeled in conformance with NRS 639.2801.
(12) Be installed in such a place and manner that a person is unable to remove the system from its location or obtain access to the system without authorization. The system must be monitored by real-time audio-visual technology or audio-visual recording technology.
(13) Be equipped with user-based access technology that includes, without limitation, an audio-visual function that allows the patient to communicate, in real time, with a dispensing practitioner who has access to any patient record necessary for counseling the patient in compliance with NAC 639.707 and 639.708.
4. A reproductive healthcare center that dispenses prescription drugs by an automated drug dispensing system pursuant to this section shall maintain a written policy that sets forth:
(a) The duties of all persons who are authorized to access the system; and
(b) The procedures for:
(1) Maintaining the security of the prescription drugs stored in the system during the maintenance and repair of the system;
(2) The preparation of an inventory of the prescription drugs stored in the system; and
(3) Stocking the system with prescription drugs.
5. A dispensing practitioner practicing at a reproductive healthcare center that dispenses prescription drugs through an automated drug dispensing system pursuant to this section shall comply with all applicable federal and state recordkeeping requirements and shall maintain those records in a readily retrievable manner separate from other medical records.
6. Prescription drugs stored in an automated drug dispensing system pursuant to this section shall be deemed part of the inventory and the responsibility of each dispensing practitioner that uses the automated drug dispensing system at the reproductive healthcare center that holds the license for the system. Prescription drugs dispensed from the system shall be deemed to have been dispensed by that dispensing practitioner or those dispensing practitioners, as applicable.
7. The Board may prohibit a reproductive healthcare center from using an automated drug dispensing system to furnish a prescription drug to a patient if the Board determines that the system, or one or more dispensing practitioners' use of the system, does not comply with this section.
8. The provisions of this section do not prohibit the use of an automated drug dispensing system to furnish a drug or device that is approved by the Food and Drug Administration for sale over the counter without a prescription if the reproductive healthcare center using the system is otherwise authorized to use the system pursuant to this section.
9. As used in this section, "reproductive healthcare center" means a health care facility that is:
(a) Owned and operated by a nonprofit corporation or a public health center, as defined in subsection 8 of NRS 449.260; and
(b) Principally engaged in providing family planning services and reproductive health care, including, without limitation, the testing, diagnosis and treatment of, or providing of medication to prevent sexually transmitted infections or other infections of the urogenital system.

Nev. Admin. Code § 639.Sec. 1.9

Added to NAC by Bd. of Pharmacy by R180-22A, eff. 12/29/2022

NRS 639.070