Section 657.9.5. General requirements for telepharmacy.

The pharmacist in charge of the managing pharmacy shall ensure that the managing pharmacy and the remote site have obtained all necessary licenses, registrations, and authorizations prior to engaging in the practice of telepharmacy at the remote dispensing site. Regardless of the fact that both the managing pharmacy and the remote site are required to be licensed, the remote site is considered an extension of the managing pharmacy.

         9.5(1) License requirements.

            a.                Managing pharmacy. A managing pharmacy shall maintain a license issued by the board pursuant to 657—8.35(155A). The license shall be a general pharmacy license. A managing pharmacy engaged in the dispensing of controlled substances shall maintain registrations with the DEA and the board.

            b.                Remote dispensing site. A remote site shall maintain a license issued by the board pursuant to 657—8.35(155A). The application for initial licensure shall include the information identified in subrules 9.5(2) and 9.5(6). The license shall be a limited use pharmacy license. If controlled substances are maintained at or dispensed from the remote site, the remote site shall maintain registrations with the DEA and the board that authorize the stocking and dispensing of controlled substances from the remote site.

         9.5(2) Need for remote dispensing site. Prior to engaging in the practice of telepharmacy with a remote dispensing site, the managing pharmacy shall demonstrate to the board that there is limited access to pharmacy services in the community where the remote site is located.

            a.               Information justifying the need for the remote dispensing site shall be submitted to the board with the initial application for licensure of the remote site as a limited use pharmacy.

            b.               The board shall consider the availability of pharmacists in the community, whether the request is for availability of patient care in a critical access area or is solely for the benefit of the managing pharmacy, whether any benefit to the managing pharmacy will balance the benefit to the patients of the remote dispensing site, the population of the community to be served by the remote site, and the need for the service.

            c.               The board shall not approve a remote dispensing site if a general pharmacy that dispenses prescription drug orders to outpatients is located within the same community as the proposed remote site or is located within 15 miles of the proposed remote dispensing site.

         9.5(3) Reference library. A managing pharmacy shall comply with the requirements for a reference library found at 657—6.3(155A); a remote site shall be exempt from complying with the requirements for a reference library.

         9.5(4) Patient notification. A remote site shall display a sign, easily visible to the public, that informs patients that the location is a remote dispensing site providing telepharmacy services supervised by a pharmacist located in another pharmacy, that identifies the city where the managing pharmacy is located, and that informs patients that a pharmacist is required to speak with the patient over an audiovisual link each time a prescription drug is delivered to the patient at the remote site.

         9.5(5) Environment and equipment. A managing pharmacy and a remote site shall comply with the requirements for environment and equipment found at 657—8.5(155A) except that a remote site that does not dispense drugs requiring refrigeration shall be exempt from complying with the requirements of 657—subrule 8.5(1).

         9.5(6) Written contract. A managing pharmacy and a remote dispensing site, unless jointly owned, shall enter into a written contract that outlines the services to be provided and the responsibilities and accountability of each party in fulfilling the terms of the contract in compliance with federal and state laws and regulations.

            a.               A copy of the contract shall be submitted to the board for approval with the initial application for licensure of the remote site as a limited use pharmacy and at any time there is a substantial change in any of the terms of the contract.

            b.               The contract shall be maintained by the managing pharmacy and shall be available for inspection or copying by the board or an agent of the board for a minimum of two years following expiration or other termination of the contract.

         9.5(7) Changes relating to remote dispensing site. Pursuant to the requirements of 657—8.35(155A), a managing pharmacy shall notify the board of a change of name, change of location, change of ownership, change of pharmacist in charge, discontinuance of service, or closure of a remote dispensing site operated by the managing pharmacy. A managing pharmacy shall also notify the board of any change of qualified certified pharmacy technician staffing at a remote dispensing site.

         9.5(8) Monthly inspection. A pharmacist shall complete and document the monthly inspection of a remote dispensing site. Inspection criteria shall be identified in the policies and procedures for the remote site, and inspection reports shall be maintained and available to the board or an agent of the board for review and copying for a minimum of 12 months from the date of the monthly inspection or until the next board inspection, whichever period is longer.