Utah Admin. Code 156-88a-205

Current through Bulletin 2025-01, January 1, 2025

Section R156-88a-205 - Operating Standards

(1) Under Subsection 58-88-205(1), the operating standards for a licensed dispensing practice shall include the standards in this section. This section does not apply to dispensing that is limited or excepted from Title 58, Chapter 88, Part 2, Dispensing Practice, including dispensing under Subsection 58-88-202(5).

(2) An LDP shall store and maintain drugs and devices to be dispensed as follows:

(a) by expiration date, with appropriate labeling and inventory documentation;

(b) in a sanitary and controlled environment in accordance with federal and state laws, rules, and regulations applicable to licensing dispensing practice; and

(c) in a secure, locked area under the control of the RDP, with access limited to the LDP's RDPs and dispensing practitioners and the individuals under their supervision.

(3) An LDP shall label dispensed drugs in accordance with federal and state laws, rules, and regulations applicable to licensed dispensing practice, and include the following:

(a) facility name, address, and phone number;

(b) patient's name;

(c) prescriber's name;

(d) medication name and strength;

(e) date dispensed;

(f) directions for use and cautionary statements; and

(g) beyond use date.

(4) LDP inventory control standards for dispensed drugs shall be in accordance with federal and state laws, rules, and regulations applicable to licensed dispensing practice, and include the following:

(a) authorized personnel shall remove out-of-date legend drugs from the inventory at regular intervals and in correlation to the beyond use date imprinted on the label;

(b) general requirements for inventory of an LDP shall include the following:

(i) the RDP shall be responsible for taking required inventories, but may delegate performance of an inventory to one or more persons;

(ii) inventory records shall be maintained for five years and be available for inspection upon request, either in hard copy or electronic format;

(iii) inventory records shall be filed separately from all other records;

(iv) inventory records shall be in a written, typewritten, printed, or electronic form;

(v) an inventory taken by use of a verbal recording device shall be promptly transcribed;

(vi) an inventory may be taken either as the opening of the business or the close of business on the inventory date;

(vii) the individual taking the inventory and the RDP shall indicate the time the inventory was taken, and shall sign and date the inventory with the date the inventory was taken;

(viii) the signature of the RDP and the date of the inventory shall be documented within 72 hours or three business days of the completed initial, annual, change of ownership, or closing inventory; and

(ix) the initial inventory shall serve as the LDP inventory until the next completed inventory.

(5) A dispensing practitioner shall provide counseling to each patient receiving a dispensed drug or device as follows:

(a) counseling shall be offered orally in person, unless the patient or patient's agent is not at the LDP or a specific communication barrier prohibits oral communication;

(b) counseling may be provided electronically;

(c) if a prescription drug or device is delivered to the patient or patient's agent, the information in Subsection (d) may be delivered with the dispensed prescription in writing; and

(d) based upon the professional judgment of the dispensing practitioner, patient counseling may include the following elements:

(i) name and description of the prescription drug;

(ii) dosage form, dose, route of administration and duration of drug therapy;

(iii) intended use of the drug and expected action;

(iv) special directions and precautions for preparation, administration and use;

(v) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action recommended if they occur;

(vi) techniques for self-monitoring drug therapy;

(vii) proper storage;

(viii) prescription refill information;

(ix) action to be taken in the event of a missed dose;

(x) comments relevant to the individual's drug therapy, including any other information specific to the patient or drug; or

(xi) date after which the prescription should not be taken or used, or the beyond use date.

(6) Only a dispensing practitioner may orally provide counseling to a patient or patient's agent and answer questions concerning a dispensed drug or device.

(7) Operating standards for closing an LDP shall be as follows:

(a) by the date of closing, the RDP shall remove the LDP prescription drugs and devices from the LDP by one or a combination of the following methods:

(i) returning to manufacturer or supplier for credit or disposal; or

(ii) selling or giving to one or more persons legally entitled to possess the drug or device, such as an LDP, underserved population clinic, hospital, or pharmacy;

(b) within ten business days of closing, the LDP shall submit a surrender notice to the Division on a form provided by the Division, which includes the following:

(i) the actual date of closing;

(ii) a surrender of the LDP license; and

(iii) a statement attesting:

(A) that the LDP has conducted a closing inventory under Section R156-88a-205; and

(B) the manner in which the LDP drugs and devices were transferred or disposed; and

(c) if the LDP is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, or other emergency circumstances, the LDP shall comply with this subsection in the detail and as promptly as allowed by the circumstances.

(8) Unlicensed LDP personnel who are supervised by a dispensing practitioner may assist in dispensing tasks not requiring professional licensure, such as:

(a) stock ordering and restocking;

(b) cashiering;

(c) billing;

(d) filing;

(e) housekeeping; and

(f) delivering a pre-filled prescription to a patient.

(9) An LDP that employs the United States Postal Service, other common carrier, or LDP personnel to deliver a filled prescription to a patient shall:

(a) use adequate storage or shipping containers and shipping processes to ensure drug stability and potency and appropriate storage temperatures throughout delivery, with packaging material and devices recommended by the manufacturer or the United States Pharmacopeia Chapter 1079;

(b) use shipping containers sealed in a manner to detect evidence of opening or tampering;

(c) have policies and procedures to ensure accountability, safe delivery, and compliance with temperature requirements, including the following:

(i) when drugs do not arrive on time or there is evidence that the integrity of a drug was compromised during shipment; and

(ii) providing for the replacement of drugs; and

(d) provide information to the patient indicating what the patient should do if the integrity of the packaging or drug was compromised during shipment.

(10) An LDP shall maintain a medication profile for each patient receiving a dispensed drug or device, as follows:

(a) a patient profile, once established, shall be maintained by the LDP on a recurring basis for a minimum of one year from the date of the most recent prescription filled; and

(b) information to be included in the profile shall be determined by the dispensing practitioner, but shall include at minimum:

(i) full name of the patient, address, telephone number, and date of birth or age and gender; and

(ii) patient history where significant, including known allergies and drug reactions, and a list of prescription drugs and devices obtained by the patient at the LDP, including:

(A) name of prescription;

(B) strength of prescription drug;

(C) quantity dispensed;

(D) date of filling;

(E) charge for the prescription drug or device as dispensed to the patient; and

(F) any additional comments relevant to the patient's drug or device use.

Utah Admin. Code R156-88a-205

Adopted by Utah State Bulletin Number 2023-02, effective 1/10/2023