Section 657.18.3. General requirements.

         18.3(1) Essential qualifications. An originating pharmacy may outsource prescription drug filling to a central fill pharmacy or prescription drug order processing to a central 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 or have appropriate technology to allow access to sufficient information necessary or required to perform the contracted functions.

         18.3(2) Legal compliance. An originating pharmacy, a central fill pharmacy, and a central processing pharmacy shall comply with all provisions applicable to the pharmacy contained in federal and state laws, rules, and regulations to the extent applicable for the specific filling or processing activity and these rules, including but not limited to the following:

            a.               Each pharmacy located within Iowa shall maintain Iowa pharmacy licensure and, if the pharmacy dispenses controlled substances, the pharmacy shall maintain DEA and Iowa controlled substances registrations.

            b.               Each pharmacy located outside Iowa shall maintain Iowa nonresident pharmacy licensure in addition to the licensure requirements of the pharmacy’s home state.

            c.               Each pharmacist providing centralized prescription drug order processing or filling functions as an employee or agent of a central processing or central fill pharmacy located within Iowa shall maintain active licensure to practice pharmacy in Iowa.

            d.               Pharmacies shall comply with Iowa board rules relating to the duties that must be performed by a pharmacist.

            e.               Pharmacies shall comply with Iowa requirements for supervision of pharmacy technicians and pharmacy support persons.

         18.3(3) Originating pharmacy responsibility. Except as specifically provided by this subrule, the originating pharmacy shall be responsible for all dispensing functions as the term “dispense” is defined in rule 18.2(155A). An originating pharmacy contracting only for centralized filling shall retain responsibility for all processing functions, and an originating pharmacy contracting only for centralized processing shall retain responsibility for all filling functions.

            a.               A mail order pharmacy engaged in the centralized filling of prescription drug orders may deliver a filled prescription directly to the patient and shall not be required to return the filled prescription to the originating pharmacy.

            b.               A central fill or a central processing pharmacy that shares a common central processing unit with the originating pharmacy may perform prospective drug use review (DUR) pursuant to rule 657—8.21(155A). Only a pharmacist shall perform the DUR; the review shall not be delegated to a pharmacy technician, registered nurse, or other pharmacy support person. The pharmacist performing the DUR shall document in the shared patient record all concerns, recommendations, observations, and comments resulting from that review. The pharmacist at the originating pharmacy shall utilize the DUR notes in counseling the patient pursuant to rule 657—6.14(155A).

         18.3(4) Central fill label requirements. The label affixed to the prescription container filled by a central fill pharmacy on behalf of an originating pharmacy shall include the following:

            a.               A unique identifier indicating that the prescription was filled at the central fill pharmacy;

            b.               Serial number (a unique identification number of the prescription) as assigned by the originating pharmacy;

            c.               The name, address, and telephone number of the originating pharmacy;

            d.               The name of the patient or, if such drug is prescribed for an animal, the species of the animal and the name of its owner;

            e.               The name of the prescribing practitioner;

            f.                The date the prescription is filled by the central fill pharmacy;

            g.               The directions or instructions for use, including precautions to be observed;

            h.               Unless otherwise directed by the prescriber, the name, strength, and quantity of the drug dispensed.

             (1)             If a pharmacist selects an equivalent drug product for a brand name drug product prescribed by a practitioner, the prescription container label shall identify the generic drug and may identify the brand name drug for which the selection is made, such as “(generic name) Generic for (brand name product)”.

             (2)             If a pharmacist selects a brand name drug product for a generic drug product prescribed by a practitioner, the prescription container label shall identify the brand name drug product dispensed and may identify the generic drug product ordered by the prescriber, such as “(brand name product) for (generic name)”;

            i.                The initials or other unique identification of the pharmacist in the originating pharmacy who performed drug use review and transmitted the prescription drug order to the central fill pharmacy.

[ARC 8673B, IAB 4/7/10, effective 6/1/10]