(1) A pharmacist must have a collaborative practice agreement with a practitioner authorized to prescribe drugs in order to administer and/or prescribe vaccinations.

(2) A pharmacist may administer vaccines to persons 18 years of age or older provided that:

(a) the pharmacist has successfully completed an accredited course of training provided by the Centers for Disease Control and Prevention (CDC), the American Council on Pharmaceutical Education or other authority approved by the board;

(b) the pharmacist holds a current basic cardiopulmonary resuscitation certification issued by the American Heart Association, the American Red Cross or other recognized provider;

(c) the vaccines are administered in accordance with an established protocol that includes emergency measures; and

(d) the pharmacist has a current copy of or on-site access to the Centers for Disease Control and Prevention reference "Epidemiology and Prevention of Vaccine-Preventable Diseases."

(3) The pharmacist must give the appropriate vaccine information statement to the patient or the patient's legal representative with each dose of vaccine covered by these forms and counsel the patient accordingly.

(4) The pharmacist must maintain written policies and procedures for disposal of used or contaminated supplies.

(5) The pharmacist must report any adverse events to the primary care provider identified by the patient and to the CDC.

(6) A pharmacist administering any vaccine shall maintain the following information in the patient's medical records for a period of at least three years:

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

(b) the date of administration;

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

(d) the vaccine information statement provided;

(e) the site and route of administration;

(f) the name and address of the patient's primary health care provider;

(g) the date on which the vaccination information was reported to the patient's primary health care provider under the provisions of the National Vaccine Injury Compensation Program;

(h) the name of the administering pharmacist; and

(i) any adverse events encountered.

(7) The authority of a pharmacist to administer immunizations may not be delegated; however, an immunization-certified intern may immunize under the direct supervision of a pharmacist qualified under this chapter.

(8) The pharmacist must provide a certified true copy of the immunization certificate and CPR certification to the board for initial endorsement on their pharmacy license.

(9) In order to maintain the immunization endorsement on their pharmacy license, an immunization certified pharmacist must:

(a) maintain current CPR certification;

(b) participate in a minimum of two hours of continuing education on immunizations or vaccine-preventable diseases every year. The continuing education must be American Council on Pharmaceutical Education (ACPE), Continuing Medical Education (CME), or Continuing Education Advisory Council (CEAC) approved; and

(c) maintain competency in vaccine administration technique by:

(i) professionally administering vaccinations to humans in the previous 12 months; or

(ii) having a Montana licensed health care provider authorized to prescribe or administer vaccines or an immunization-certified pharmacist witness and validate the pharmacist's vaccine administration technique every year.

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