A. Upon receipt of a prescription written by a licensed practitioner who may prescribe drugs or biological products for a drug or biological product for which one or more multiple-source drugs or interchangeable biological products are recognized, listed as final determinations and published in the federal register by the federal department of health and human services, a pharmacist may dispense any one of the drugs or interchangeable biological products that satisfies the final determinations so recognized and listed by the federal department of health and human services and is sold at a lower cost than the drug or biological product listed in the prescription.
B. Upon receipt of a prescription written by a licensed practitioner for a drug or biological product that appears on the federal food and drug administration's approved prescription drug products with therapeutic equivalence evaluation list as supplemented, or for a biological product that is listed as interchangeable on the lists of the federal food and drug administration's lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations, as supplemented, a pharmacist may dispense any of the listed therapeutically equivalent drugs or interchangeable biological products that is lower in cost than the prescribed drug or biological product.
C. Drug and biological product selection shall be permitted only under circumstances and conditions set forth in Subsections A and B of this section unless the licensed practitioner prescribing prohibits drug or biological product selection. A licensed practitioner shall prohibit drug or biological product selection by making an entry that is electronically accessible that includes the words "no substitution" or the diminution "no sub" on a prescription.
D. If drug or biological product selection occurs as permitted in Subsections A and B of this section, the pharmacist shall indicate on the label of the dispensed container the brand of drug or the specific biological product prescribed and the name of the drug or interchangeable biological product dispensed.
E. A pharmacist who selects an interchangeable biological product shall inform the patient or the patient's representative.
F. A pharmacist shall not select a therapeutically equivalent drug or interchangeable biological product unless the substitution is in accordance with the provisions of Subsection A of this section.
G. Within five business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall make an entry of the specific product provided to the patient, including the name of the product and the manufacturer. The communication shall be conveyed by making an entry that is electronically accessible to the prescriber through:
(1) an interoperable electronic medical records system;
(2) an electronic prescribing technology;
(3) a pharmacy benefit management system; or
(4) a pharmacy record.
H. Entry into an electronic medical records system pursuant to Subsection G of this section is presumed to provide notice to the prescriber. Otherwise, the pharmacist shall communicate to the prescriber what biological product was dispensed, using facsimile, telephone, electronic transmission or other prevailing means; provided that communication shall not be required when:
(1) there is no interchangeable biological product that has been approved by the federal food and drug administration for the product prescribed; or
(2) a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
I. The board shall maintain a link on its website to the current lists of all biological products that the federal food and drug administration has determined to be interchangeable biological products.
J. For purposes of this section:
(1) "multiple-source drug" means a drug marketed or sold by two or more manufacturers, formulators or labelers; and
(2) "therapeutically equivalent" means drug products that have the same amount of the active drug in the same dosage form that when administered can be expected to provide the same therapeutic effect.
History: 1953 Comp., § 54-6-28.3, enacted by Laws 1976, ch. 60, § 4; 1982, ch. 26, § 1; 2005, ch. 152, § 4; 2017, ch. 48, § 2.
ANNOTATIONSThe 2017 amendment, effective June 16, 2017, provided for the regulation of biosimilar products, including authorizing pharmacists to substitute biosimilar and interchangeable biosimilar biologic products for another biologic product that has been prescribed by a physician, placed certain duties on pharmacists who select an interchangeable biological product, required the board of pharmacy to maintain a link on its website to the current lists of all biological products that the federal food and drug administration has determined to be interchangeable biological products, and redefined "therapeutically equivalent"; added "and biological", "or biological", "or biological products" and "or interchangeable biological products" throughout the section; in the catchline, added "and biological"; in Subsection B, after "supplemented", added "or for a biological product that is listed as interchangeable on the lists of the federal food and drug administration's lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations, as supplemented", after "a pharmacist may dispense any of the", added "listed", after "that", deleted "appears on that list and which", after "lower in cost than the", added "prescribed", and after the next occurrence of "drug", deleted "listed in the prescription"; in Subsection C, after "product selection by", deleted "writing with his hand" and added "making an entry that is electronically accessible that includes", and after "'no sub' on", deleted "the face of"; in Subsection D, after "brand of drug", added "or the specific biological product"; deleted former Subsection E; added new Subsections E through I, and redesignated former Subsection F as Subsection J; in Subsection J, added the paragraph designation "(1)", and added Paragraph J(2); and deleted former Paragraph G, which defined "therapeutically equivalent".
The 2005 amendment, effective June 17, 2005, deleted Subsection E, which required a pharmacist to notify the prescribing practitioner if the pharmacist changes the drug dispensed after the drug selection has occurred and relettered the subsequent subsections.