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(1) A pharmacy may outsource prescription drug order filling or processing to a central filling or processing pharmacy provided the pharmacies:

(a) have the same owner or have entered into a written contract or agreement that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws, rules, and regulations; and

(b) share a common electronic file.

(2) A pharmacy that outsources prescription drug order filling or processing to another pharmacy shall, prior to outsourcing a prescription drug order:

(a) notify the patient or the patient's agent that prescription filling or processing may be outsourced to another pharmacy;

(b) provide the name of the pharmacy that will be filling or processing the prescription or, if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may fill or process the prescription, the patient shall be notified of this fact; and

(c) clearly show the name, address, and telephone number of the delivering pharmacy on the prescription container.

(3) The patient shall have the choice not to have the prescription outsourced.

(4) Each pharmacy engaging in centralized prescription processing shall be jointly responsible for properly filling the prescription.

(5) The delivering pharmacy is responsible for providing patient counseling. (6) All central filling or processing of prescription drug orders must be completed in a licensed pharmacy.

(7) Pharmacies providing central processing or central filling services to pharmacies in the state of Montana must be licensed in Montana.

(8) An out-of-state pharmacy providing central processing or central filling services to pharmacies in the state of Montana must be registered as an out-of-state mail service pharmacy and comply with all Montana statutes and rules regulating mail order pharmacies.

(9) A policy and procedure manual relating to centralized filling or processing activities shall be maintained at all pharmacies involved in centralized filling or processing. An electronic copy of the policy and procedure manual shall be submitted to the board. Thereafter the manual shall be available for inspection and copying by the board. The policies and procedures shall:

(a) outline the responsibilities of each of the pharmacies which must include but is not limited to:

(i) receiving, interpreting, or clarifying prescription orders;

(ii) entering data and transferring prescription information;

(iii) obtaining refill and substitution authorization information;

(iv) performing drug regimen review;

(v) interpreting clinical data for prior authorization dispensing;

(vi) performing therapeutic interventions; and

(vii) providing drug information.

(b) include a list of the name, address, telephone numbers, and license or registration number of the pharmacies participating in central filling or processing; and

(c) include policies and procedures for:

(i) protection of the confidentiality and integrity of patient information;

(ii) maintenance of appropriate records to identify the names, initials, or identification codes and specific activities of each of the pharmacists and/or technicians who performed any processing; and

(iii) compliance with federal, DEA, and state laws and regulations;

(iv) operation of a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and

(v) annual review of the written policies and procedures and documentation of such review.

History: 37-7-201, MCA; IMP, 37-7-201, 37-7-321, MCA; NEW, 2007 MAR p. 1936, Eff. 11/22/07.

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