Mont. Admin. r. 24.174.831

Current through Register Vol. 23, December 6, 2024

Rule 24.174.831 - PRESCRIPTION REQUIREMENTS

(1) Prescriptions shall include, but not be limited to:

(a) patient's name;

(b) name of drug, device, or biological;

(c) strength of drug or biological, if applicable;

(d) dosage form of drug or biological, if applicable;

(e) quantity of drug, device, or biological prescribed;

(f) directions for use;

(g) date of issuance;

(h) prescriber's name;

(i) number of refills authorized.

(2) A prescription and any refills for a non-controlled drug, device, or biologic are valid for one year from date of issuance.

(3) Prescriptions shall comply with all federal DEA requirements for prescriptions, dispensing, and refills of controlled substance in Schedules II, III, IV, and V, pursuant to 21 CFR 1306 .

(4) If the prescription is written, it must contain the prescriber's hand- written signature and the name of the prescriber stamped, typed, printed, or clearly handwritten in addition to the signature, must be tamper-resistant, and contain:

(a) one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) one or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription pad by the prescriber; and

(c) one or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

(5) If the prescription is for a controlled substance, all state and federal requirements must be met, and the following additional information is required to be on the prescription:

(a) patient's address;

(b) prescriber's address; and

(c) if a prescription is for a controlled substance in Schedules III, IV, or V, refill five times in the six months from the date of issuance;

(6) Prescription or refill authorization issued by a prescriber may be communicated to a pharmacist or a pharmacist intern by an employee or agent of the prescriber.

(7) "Brand name medically necessary" shall be handwritten (or printed if electronically generated) on the face of the prescription if it is medically necessary that an equivalent drug product not be selected.

(8) Prescription records may be electronically stored and maintained if they remain legible and are in a readily retrievable format, and if federal law does not require them to be kept in a hard copy format, pursuant to DEA requirements in 21 CFR 1304.06.

Mont. Admin. r. 24.174.831

Renumbered from 24.174.510 to 24.174.831, 2015 MAR p. 303, Eff. 3/27/2015; AMD, 2024 MAR p. 2219, Eff. 9/21/2024

AUTH: 37-7-201, MCA; IMP: 37-7-201, 37-7-505, MCA