(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 18 years of age or older; 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 37-7-105(3)(a), 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:

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

(b) have access to a current edition of the United States Centers for Disease Control and Prevention (CDC) reference "Epidemiology and Prevention of Vaccine-Preventable Diseases";

(c) provide a copy of the most current vaccine information statement (VIS) to the patient or the patient's legal representative, as required by 37-7-105(2)(b), MCA;

(d) 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;

(e) ensure that the individual immunized is assessed for contraindications to immunization, as required by 37-7-105(2)(a), MCA;

(f) report any significant adverse events to the primary care provider if one is identified by the patient, and to the Vaccine Adverse Events Reporting System (VAERS), if applicable, as required by 37-7-105(2)(c), MCA; and

(g) maintain the following information in the patient's medical records for a period of at least seven years, as required by 37-7-105(2)(d), MCA, which shall be considered confidential information:

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

(ii) the date of administration;

(iii) the name, manufacturer, dose, lot number, and expiration date of the vaccine;

(iv) the vaccine information statement provided;

(v) the site and route of administration;

(vi) the name or identifiable initials of the administering pharmacist; and

(vii) any adverse events encountered.

(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.