24.174.1802    DISPENSING REQUIREMENTS

(1)  A dispenser registrant shall: 

(a)  create a written or electronic prescription drug order for each drug dispensed and maintain such information in the patient's chart or record, pursuant to ARM 24.174.831, and 37-7-101(43) and 50-31-307, MCA, which shall include the following, but not be limited to:

(i)  patient's name;

(ii)  name of drug;

(iii)  strength;

(iv)  dosage form;

(v)  quantity;

(vi)  directions for use;

(vii)  date of issuance; and

(viii)  prescriber's name;

(b)  perform in person the final verification check of each drug prior to dispensing that, at a minimum, includes the following:

(i)  ensuring the prescription drug product and label match the prescription drug order and the information on the manufacturer's label with respect to drug, dosage form, strength, quantity, and drug identification number;

(ii)  verifying the prescription product label matches the prescription drug information with respect to prescription requirements in ARM 24.174.831;

(iii)  verifying the drug has not expired and will not expire within the duration of use;

(iv)  ensuring the registrant has completed a prospective drug utilization review after reviewing the patient profile; and

(v)  documenting that the final verification check was completed by the registrant; and

(c)  directly prepare, dispense, and deliver the drug, including subsequent fills or refills, in person to their patient(s) pursuant to the provisions in 37-2-104(2) and 50-31-307, MCA. The drug may not be dispensed or delivered by mail or common carrier.

(2)  A registrant shall comply with all federal and state statutes and regulations regarding dispensing of prescription drugs, including all requirements for the registrant to:

(a)  perform a prospective drug utilization review, pursuant to 37-7-101(17) and 37-7-406, MCA, and ARM 24.174.902;

(b)  provide patient labeling, pursuant to 37-7-101(14), MCA, and ARM 24.174.301(23), 24.174.832, and 24.174.833, including:

(i)  the prescription label shall contain the name, address, and phone number of the registrant, name of patient, name and strength of drug, directions for use, and date of filling;

(ii)  the prescription label must be securely attached to the outside of the container in which the drug is dispensed; and

(iii)  the registrant shall provide Medication Guides and/or Patient Package Inserts, comply with Risk Evaluation and Mitigation Strategies, and/or other labeling requirements as required by the U.S. Food and Drug Administration;

(c)  develop a protocol to manage, store, and secure prescription drug dispensing inventory, pursuant to ARM 24.174.301(43), 24.174.814, 24.174.818, and 24.174.819, including:

(i)  operating in a sanitary manner;

(ii)  restricting access only to authorized individuals as determined by the registrant;

(iii)  assuring that physical access to prescription drugs for dispensing is denied to all individuals at all times when a registrant is not on the premises, except with regard to dispensing pursuant to 37-2-104(8), MCA;

(d)  maintain recordkeeping, pursuant to ARM 24.174.833, with records available for inspection by the board;

(e)  compound drug products, including non-sterile and sterile products, pursuant to ARM 24.174.841;

(f)  provide patient counseling, pursuant to 37-7-101(31) and 37-7-406, MCA, and ARM 24.174.903;

(g)  provide notification that the patient may request dispensing of a less expensive therapeutically equivalent generic or interchangeable biologic product pursuant to 37-7-502 and 37-7-506, MCA, if applicable; and

(h)  implement and have in place a quality assurance program to detect, identify, and prevent prescription errors, pursuant to ARM 24.174.407.

(3)  With regard to inspections by the board or its designee, a registrant shall resolve conditions identified in an inspection report, if applicable.

(4)  Prescription drugs dispensed by a registrant may not be transferred to another practitioner or pharmacist for subsequent filling or refills.

 

History: 37-7-201, MCA; IMP, 37-2-104, 37-7-201, MCA; NEW, 2021 MAR p. 1673, Eff. 11/20/21.