Administrative Rules of Montana
Department 24 - LABOR AND INDUSTRY
Chapter 24.174 - BOARD OF PHARMACY
Subchapter 24.174.18 - Medical Practitioner Dispensing
Rule 24.174.1803 - DISPENSER RECORDKEEPING REQUIREMENTS
Universal Citation: MT Admin Rules 24.174.1803
Current through Register Vol. 18, September 20, 2024
(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.
AUTH: 37-7-201, MCA; IMP: 37-2-104, 37-7-201, MCA
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