Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-17-3 - Substitution Requirements3.1. A pharmacist may dispense an interchangeable biological product if: 3.1.1. The interchangeable biological product costs the patient less than or the same amount as the prescribed drug product;3.1.2. The patient does not refuse the substitution; and3.1.3. The practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.3.2. Dispensing directive.3.2.1. General requirements. The following is applicable to the dispensing directive outlined in this subsection.3.2.1.a. When a prescription is issued for a brand name product that has no interchangeable biological equivalent, the pharmacist must dispense the brand name product. If an interchangeable biological product becomes available, a pharmacist may substitute the interchangeable biological product unless the practitioner has specified on the initial prescription that the brand name product is medically necessary.3.2.1.b. If the practitioner has prohibited substitution through a dispensing directive in compliance with this subsection, a pharmacist shall not substitute an interchangeable biological product unless the pharmacist obtains verbal or written authorization from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient.3.2.2 Written prescriptions. 3.2.2.a A practitioner may prohibit the substitution of an interchangeable biological product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."3.2.2.b. The dispensing directive shall comply with federal and state law, including rules, with regard to formatting and security requirements3.2.2.c. The dispensing directive specified in this section may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.3.2.2.d. A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this section. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.3.2.3. Verbal prescription. 3.2.3.a. If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacist shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order.3.2.3.b. If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug or interchangeable biological product.3.2.4. Electronic prescription drug orders. 3.2.4.a. To prohibit substitution, the practitioner or practitioner's agent shall clearly indicate substitution instructions in the electronic prescription drug order.3.2.4.b. If the practitioner or practitioner's agent does not indicate or does not clearly indicate in the electronic prescription drug order that the brand is necessary, the pharmacist may substitute an interchangeable biological product.3.2.5. Refills. All refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner's agent.