PURPOSE: The purpose of this rule is to establish minimum standards of operation for Class J: Shared Services Pharmacy, in compliance with House Bill 567 of the 91st General Assembly.

1. (1) Class J: Shared Services: Shared Service Pharmacy is defined as the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order, or that performs or assists in the performance of functions associated with the dispensing process, drug utilization review (DUR), claims adjudication, refill authorizations, and therapeutic interventions.

   1. (A) A pharmacy may perform or outsource centralized prescription processing services provided the parties:

      1. 1. Have the same owner, or have a writ-

ten 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;

1. 2. Maintain separate licenses for each

location involved in providing shared services; and

1. 3. Share a common electronic file to

allow access to sufficient information necessary or required to fill or refill a prescription drug order.

1. (B) There must be record keeping systems between shared service pharmacies with real time on-line access to shared services by both pharmacies. Transfer of prescription information between two (2) pharmacies that are accessing the same real-time, on-line database pursuant to the operation of a shared service pharmacy operation shall not be considered a prescription transfer and, therefore, is not subject to the requirements of 4 CSR 220-2.120.

2. (C) The parties performing or contracting for centralized prescription processing services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the board for review upon request and that includes, but is not limited to, the following:

   1. 1. A description of how the parties will

comply with federal and state laws and regulations;

1. 2. The maintenance of appropriate

records to identify the responsible pharmacist(s) in the dispensing and counseling processes;

1. 3. The maintenance of a mechanism for

tracking the prescription drug order during each step in the process;

1. 4. The provision of adequate security to

protect the confidentiality and integrity of patient information;

1. 5. The maintenance of a quality assur-

ance 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.

AUTHORITY: sections 338.140, 338.240, and 338.280, RSMo 2000 and 338.210 and 338.220, RSMo Supp. 2001.* This rule originally filed as 4 CSR 220-2.650. Original rule filed Nov. 30, 2001, effective June 30, 2002. Amended: Filed Dec. 3, 2002, effective June 30, 2003. Moved to 20 CSR 2220-2.650, effective Aug. 28, 2006. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.210, RSMo 1951, amended 2001; 338.220, RSMo 1951; amended 1969, 1981, 1989, 1997, 1999, 2001; 338.240, RSMo 1951 and 338.280, RSMo 1951, amended 1971, 1981.