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6800.4075 CENTRALIZED PRESCRIPTION PROCESSING AND FILLING.

Subpart 1.

Licensure.

A.

A central service pharmacy located in another state that provides any services listed in part 6800.0100, subpart 1c, to a pharmacy located in this state shall be licensed as a nonresident pharmacy according to Minnesota Statutes, section 151.19, subdivision 2.

B.

A central service pharmacy located in this state that provides any services listed in part 6800.0100, subpart 1c, to a pharmacy located in any state shall be licensed as a pharmacy according to Minnesota Statutes, section 151.19, subdivision 1.

Subp. 2.

Requirements; policy and procedures.

A.

A pharmacy may perform or outsource centralized prescription drug order filling or centralized prescription drug order processing services provided:

(1)

the parties have the same owner or have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations;

(2)

the parties share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a prescription drug order;

(3)

the central service pharmacy is licensed according to part 6800.0300; and

(4)

the parties provide the board with a copy of the policy and procedures manual described in item B at least 30 days before centralized prescription drug order processing services begin.

B.

The parties performing or contracting for centralized prescription drug order processing services shall maintain a policy and procedures manual and documentation that operations are occurring in a manner consistent with the manual. The manual shall be made available to the board for review upon request and shall include, at a minimum, the following:

(1)

a description of how the parties will comply with federal and state laws and regulations;

(2)

the maintenance of appropriate records to identify the responsible pharmacist in the dispensing and counseling processes;

(3)

the maintenance of a mechanism for tracking the prescription drug order during each step in the dispensing process;

(4)

the maintenance of a mechanism to identify on the prescription label all pharmacies involved in dispensing the prescription drug order;

(5)

the provision of adequate security to protect the integrity and prevent the illegal use or disclosure of protected health information; and

(6)

the maintenance 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.

Subp. 3.

Certification and counseling.

A.

A pharmacist or pharmacist intern at the pharmacy that dispenses, delivers, mails, or ships the completed prescription drug order to the patient is responsible for certifying the completed prescription drug order, except as provided for in Minnesota Statutes, section 151.215.

B.

A pharmacist or pharmacist intern at the pharmacy that dispenses, delivers, mails, or ships the completed prescription drug order to the patient is responsible for counseling the patient according to part 6800.0910.

Subp. 4.

Notification.

A pharmacy utilizing a central service pharmacy to provide dispensing functions, drug utilization review, packaging, labeling, delivery of a completed prescription drug order, or other services must notify its patients of that fact.

Statutory Authority:

MS s 151.06; 152.02

History:

31 SR 1673; 36 SR 237

Published Electronically:

September 21, 2011