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(1) In an institutional facility, drugs may be provided for use by authorized personnel through drug kits prepared by the registered pharmacist providing pharmaceutical services to the facility. Such drug kits must meet all of the following requirements:

(a) a registered pharmacist shall prepare and seal the drug kit for a supplying pharmacy;

(b) the supplying pharmacy and the designated practitioner or appropriate committee of the institutional facility shall jointly determine the identity and quantity of drugs to be included in the drug kit;

(c) the drug kit must be locked and stored in a secure area to prevent unauthorized access and to ensure a proper storage environment for the drugs contained therein;

(d) all drugs in the drug kit must be properly labeled, including lot number and expiration date, and shall possess any additional information that may be required to prevent risk of harm to the patient;

(e) the exterior of the drug kit must be clearly labeled to indicate:

(i) expiration date of the drug kit. The expiration date of a drug kit must be the earliest date of expiration of any drug supplied in the drug kit. On or before the expiration date, the supplying pharmacy shall replace the expired drug;

(ii) the name, address, and telephone number of the supplying pharmacy; and

(iii) a statement indicating that the drug kit is to be used in situations only pursuant to a valid drug order;

(f) if a drug kit is being utilized for an emergency drug cart or crash cart in an inpatient setting, as defined in ARM 24.174.301(15):

(i) the pharmacist-in-charge must maintain policies and procedures for access to the cart; and

(ii) a pharmacist must review access to the cart within 72 hours of drug removal.

(2) Except as provided for in (1)(f), drugs shall be removed from drug kits in compliance with the following: 

(a) by authorized licensed personnel pursuant to policies and procedures referenced in (4); and 

(b) a pharmacist must:  

(i) review the drug order prior to removal of a controlled substance; or 

(ii) review the drug order within 72 hours of removal of a non-controlled substance.

(3) Removal of any drug from a drug kit by authorized personnel must be recorded in an electronic record or on a suitable form showing the following information:

(a)  patient name;

(b)  name, strength, and quantity of drug removed;

(c)  date and time the drug was removed;

(d)  signature of the authorized personnel removing the drug; and

(e)  documentation of pharmacy review.

(4) The supplying pharmacy shall, in conjunction with the appropriate institutional committee, be responsible for development and annual review of policies and procedures for safe and appropriate use, access by authorized licensed personnel, restocking, and maintenance of drug kits.

(5)  Documentation for all drugs that have been removed from the drug kit shall be kept at the institutional facility and at the supplying pharmacy for two years and be available upon inspection.

(6)  The drug kit, policies and procedures, and related records shall be available upon inspection.

(7)  The supplying pharmacy and appropriate designated practitioner of a licensed facility will provide adequate controls to prevent drug diversion.

(8)  The supplying pharmacy shall submit to the board and have available for inspection:

(a)  an application for a drug kit endorsement;

(b)  a list of drug kit locations; and

(c)  any change to drug kit locations at the time of such change.


History: 37-7-201, MCA; IMP, 37-7-201, MCA; NEW, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2021 MAR p. 1671, Eff. 11/20/21.

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