(1) The pharmacy shall have written policies and procedures describing the program, which shall set forth, at a minimum, how the pharmacy will comply with this section.

(2) Before a patient enrolls, the pharmacy shall provide a written or electronic notice summarizing the program to the patient or patient's agent. Such notice shall include, at a minimum, instructions about how to withdraw a prescription medication from refill through the program or to disenroll entirely from the program. The patient or patient's agent shall enroll by written, online, or electronic informed consent to participate in the program for each new prescription wherein there is a change in the prescription medication, strength, dosage form, or directions for use.

(3) For each prescription to be refilled through the program, the pharmacy shall obtain annual renewal of each prescription from the patient or patient's agent no later than 12 months after the prescription was enrolled in the program.

(4) The pharmacy shall keep a copy of the written or electronic informed consent to enroll on file for one year from date of dispensing.

(5) The pharmacy shall complete a drug regimen review for each prescription refilled through the program at the time of refill.

(6) Each time a prescription is refilled through the program, the pharmacy shall provide a written or electronic notification to the patient or patient's agent confirming that the prescription medication is being refilled through the program.

(7) The patient or patient's agent shall at any time be able to withdraw a prescription medication from automatic refill or to disenroll entirely from the program. The pharmacy shall document and maintain such withdrawal or disenrollment for one year from the date of withdrawal or disenrollment and shall provide confirmation to the patient or patient's agent.

(8) The pharmacy shall provide a full refund to the patient, patient's agent, or payer for any prescription medication refilled through the program if the pharmacy was notified that the patient did not want the refill, regardless of the reason, or the pharmacy had been notified of withdrawal or disenrollment from the program prior to dispensing the prescription medication.

(9) A pharmacy shall make available any written or electronic notification required by this section in alternate languages as required by state or federal law.