24.174.1803    DISPENSER RECORDKEEPING REQUIREMENTS

(1)  A registrant shall keep readily retrievable at each dispensing location records of dispensing and inventory, pursuant to ARM 24.174.833: 

(a)  a copy of the registrant's dispenser license;

(b)  a record of each final verification check by the registrant;

(c)  the registrant's protocols for handling drug recalls, including the arrangements for notifying patients;

(d)  the registrant's protocols for disposal of drugs;

(e)  with respect to a supplier from whom the registrant purchased prescription drugs:

(i)  the name, address, and phone number of each wholesale drug distributor supplier, as defined in 37-7-602(8), MCA, and ARM 24.174.1201; and

(ii)  documentation including:

(A)  for each wholesale drug distributor supplier, the number and the expiration date of the license issued by the board; and

(B)  for any pharmacy supplier acting as a wholesale drug distributor, the number and the expiration date of the pharmacy license issued by the board;

(f)  any other purchasing, inventory, and dispensing records required by state or federal statutes or regulations;

(g)  a manual or electronic dispensing record must be maintained separately from the patient medical record and kept for a minimum of two years.  If an electronic health information system, as defined in 37-7-101(22), MCA, is utilized, the system must be able to produce a separate dispensing record; and

(h) the dispensing record must show, at a minimum, the following for original and subsequent fills or refills, in compliance with ARM 24.174.833:

(i)  name of patient;

(ii)  unique identifier;

(iii)  dose, dosage form, quantity dispensed, and either the brand name of drug or generic name and name of manufacturer;

(iv)  directions for use;

(v)  date of dispensing; and

(vi)  initials of registrant dispensing the prescription.

(2)  In addition to meeting the requirements of ARM 24.174.1802, the registrant shall comply with any other state or federal law or regulation relating to dispensing of prescription drugs.

(3)  Records must be available for inspection by the board.

 

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