Current through Register Vol. XLI, No. 25, June 21, 2024
Section 15-17-2 - Definitions2.1. "Biological product" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative or arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.2.2. "Biosimilar" means a biological product that has been licensed as a biosimilar pursuant to 42 U.S.C. § 262(k), reflecting that it is highly similar to the specific reference biological product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the reference biological product in terms of safety, purity, and potency of the product.2.3. "Brand name" means the proprietary or trade name selected by the manufacturer and placed upon a drug or drug product, its container, label, or wrapping at the time of packaging.2.4. "Interchangeable biological product" means a biological product that the federal Food and Drug Administration has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C § 262(k)(4) or determined is therapeutically equivalent as set forth in the latest edition of or supplement of the federal Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations.2.5. "Original prescription" means either the original written prescription drug order, or the original verbal or electronic prescription drug orders reduced to writing either manually or electronically by the pharmacist.2.6. "Proper name" means the nonproprietary name of a biological product.2.7. "Reference biological product" means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 42 U.S.C. § 262(k).2.8. "Substitute" means to dispense without the prescriber's express authorization an interchangeable biological product in the place of the drug ordered or prescribed.2.9. "Therapeutically equivalent" means pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.