Standards of Operation for a Class J: Shared Services Pharmacy

PURPOSE: The purpose of this rule is to establish standards for Class J: Shared Services pharmacies. (1) Class J Shared Services. A Class J Shared Services permit is required if two (2) or more pharmacies are engaged in, or have an arrangement to provide, functions related to the practice of pharmacy for or on behalf of the other pharmacy. These functions may include, but are not limited to, prescription/ order receipt, prescription/order clarification or modification, obtaining prescriber authorization, data entry, compounding, dispensing, pharmacist verification, patient counseling, patient profile maintenance, medication therapy services, medication administration, drug utilization review (DUR), and obtaining refill authorization. All pharmacies participating in the shared services arrangement must have a Class J permit. (A) Pharmacies may perform Class J Shared Services provided the parties— 1. Have the same owner or have a written contract outlining the services to be provided and the responsibilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations; 2. Maintain a separate Class J classification for each location involved in providing shared services; and 3. Either share a common database or have access to each pharmacy’s prescription records and patient profiles and records, as needed to safely and properly perform the shared services activities. (B) Class-J pharmacies operating in compliance with this section are exempt from the requirements of 20 CSR 22202.120 and 20 CSR 2220-6.030(4) when transferring prescription information between themselves. A Class-J permit is not required to transfer an individual prescription as authorized by 20 CSR 2220-2.120 pursuant to a request by the patient or the patient’s authorized designee. (C) The parties performing Class J Shared Services shall maintain a detailed written description of authorized shared services that includes the name, address, and permit number(s) of all pharmacies involved. The parties must maintain a current and accurate policy and procedure manual that includes, but is not limited to, the following: 1. Policies and procedures that identify the duties and responsibilities of each pharmacy including any functions identified in section (1). The required policies and procedures must also identify the pharmacy responsible for— A. Verifying prescription/medication order accuracy and validity; B. Data entry verification; C. Drug utilization review as required by 20 CSR 22202.195; D. Final product verification; and E. Patient counseling; 2. A mechanism for tracking the prescription or medication order during each step in the process; 3. Security provisions for protecting the confidentiality and integrity of patient information; 4. Policies and procedures to ensure the safe and appropriate delivery of prescription drugs in compliance with 20 CSR 2220-2.013; and AND INSURANCE 5. A designation of the pharmacy responsible for offering patient counseling as required by 20 CSR 2220-2.190 and federal law. For purposes of section 338.059, RSMo, the name and address of either the pharmacy responsible for offering patient counseling or the pharmacy responsible for dispensing to the patient may be listed on the label as designated by the pharmacies by contract. (D) Each pharmacy involved in a Class-J arrangement must maintain a quality assurance program that is designed to objectively and systematically monitor and evaluate the quality and appropriateness of pharmacy services and resolve identified problems. (E) Compounding may only be performed pursuant to a Class-J pharmacy arrangement pursuant to a patient-specific prescription or in anticipation of a patient-specific prescription as authorized by 20 CSR 2220-2.200 and the rules of the board. (F) A Class-J permit is not required for pharmacists performing non-dispensing activities authorized by 20 CSR 2220-6.050 outside of a licensed pharmacy. (2) A Class J Shared Services permit shall not be required if a completed and labeled prescription is delivered from a Missouri licensed pharmacy to another Missouri licensed pharmacy for administration by a pharmacist or other licensed health care professional to the patient on the same premises or physical location as the pharmacy. (A) The exemption recognized in this subsection only applies if a completed and labeled prescription is delivered to the receiving pharmacy. (B) If additional manipulation or compounding is required by the receiving pharmacy, receipt of a prescription or order is required and the receiving pharmacy must dispense the product as their own prescription/order. All prescription requirements, record keeping, compounding, and labeling requirements must be met. (C) The receiving pharmacy must maintain documentation of the medication received, the name and address of the pharmacy providing the medication, the date of receipt, and the patient’s name. (D) The receiving pharmacy is responsible for ensuring compliance with all applicable patient counseling requirements. (E) For purposes of this rule, administration is defined as applying or introducing medication to the body of a patient, whether by injection, infusion, inhalation, ingestion, or other means. (F) Medication administered by a pharmacist must be performed in compliance with all applicable provisions of law. (G) Notwithstanding any other provision of this rule, licensees shall comply with all applicable controlled substance laws and regulations, including, but not limited to, all applicable security and record keeping requirements. (3) A Class J Shared Services permit is not required for pharmacies that have an arrangement to provide only initial dispensing services for a Class C pharmacy, as allowed under 20 CSR 2220-2.120(4). (4) A pharmacy participating in Class J Shared Services with a pharmacy that is not under common ownership must notify patients that his/her prescription or medication order may be filled or compounded by another pharmacy. (5) All records required by this rule including all policy and procedure manuals, contracts, quality assurance documentation, or other agreements must be maintained for two (2) years and must be made available to the board or its representative upon request. AUTHORITY: sections 338.240 and 338.280, RSMo 2016, and sections 338.140, 338.210, and 338.220, RSMo Supp. 2021.* 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. Emergency amendment filed July 27, 2017, effective Aug. 6, 2017, expired Feb. 22, 2018. Amended: Filed July 27, 2017, effective Jan. 30, 2018. ** Amended: Filed Aug. 23, 2021, effective Feb. 28, 2022. *Original authority: 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.210, RSMo 1951, amended 2001, 2011, 2020; 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009, 2011, 2013, 2014, 2020; 338.240, RSMo 1951, amended 2011; and 338.280, RSMo 1951, amended 1971, 1981. **Pursuant to Executive Order 21-09, 20 CSR 2220-2.650 was suspended from March 20, 2020 through December 31, 2021.