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(1) An immunization-certified pharmacist may prescribe and administer those immunizations listed in 37-7-105, MCA, without a collaborative practice agreement in place, as required by the statute.

(2) An immunization-certified pharmacist must have a collaborative practice agreement with a practitioner authorized to prescribe drugs to administer immunizations not listed in 37-7-105, MCA, to persons seven years of age or older, as provided in the most recent guidelines by vaccine and age group published by the U.S. Centers for Disease Control and Prevention (CDC) and as determined within a collaborative practice agreement; or, in the case of a public health emergency, a directive from the State Medical Officer of the Montana Department of Public Health and Human Services.

(3) An immunization-certified pharmacist, as defined in 37-7-101, MCA, shall:

(a) provide a copy of the immunization certificate and current basic cardiopulmonary resuscitation (CPR) certification to the board for initial endorsement on license; and

(b) maintain documentation of immunization endorsement and current CPR certification on file at the practice site.

(4) In order to administer immunizations, with or without a collaborative practice agreement, an immunization-certified pharmacist must meet the requirements of 37-7-105, MCA, and:

(a) administer vaccinations in accordance with established protocol that includes site-specific emergency measures;

(b) have access to a current edition of the CDC reference "Epidemiology and Prevention of Vaccine-Preventable Diseases";

(c) maintain the following:

(i) written policies and procedures for the types of immunizations administered;

(ii) specific description of the procedures, methods, and decision criteria to follow for administering the immunization;

(iii) a detailed description of the procedures and patient activities to follow in the course of administering immunizations;

(iv) training for staff procedures and record keeping requirements; and

(v) disposal of used or contaminated supplies; and

(d) maintain the following information in the patient's medical records as required by 37-7-105, MCA, which shall be considered confidential information:

(i) the patient's name, address, allergies, and date of birth;

(ii) the product's name, dose, manufacturer, lot number, and expiration date;

(iii) the date of administration;

(iv) the site and route of administration; and

(v) the administering pharmacist's name or identifiable initials and the pharmacy's address.

(5) The authority of a pharmacist to administer immunizations may not be delegated; however, a pharmacy intern may immunize under the direct supervision of an immunization-certified pharmacist or other healthcare provider qualified in vaccine administration and deemed appropriate by the preceptor upon meeting the immunization-certified requirements listed in 37-7-105, MCA, and this rule.

(6) The board shall randomly select renewal notice forms of immunization-certified pharmacists for audit and verification of the requirements listed in this rule. 


History: 37-7-201, MCA; IMP, 37-7-101, 37-7-105, 37-7-201, MCA; NEW, 2002 MAR p. 794, Eff. 2/1/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2011 MAR p. 1148, Eff. 6/24/11; AMD, 2012 MAR p. 896, Eff. 4/27/12; AMD, 2015 MAR p. 1491, Eff. 9/25/15; AMD, 2019 MAR p. 2240, Eff. 12/7/19.

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