Sec. 3. As used in this chapter, "interchangeable" means:
(1) a determination by the federal Food and Drug Administration that a biosimilar product may be substituted for a reference biological product without the intervention of the health care provider that prescribed the biological product; or
(2) concerning a biological product filed under 21 U.S.C. 355(b)(2), a product that is designated as therapeutically equivalent by the federal Food and Drug Administration in the Approved Drug Products with Therapeutic Equivalence Evaluations.
As added by P.L.96-2014, SEC.6.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 25. Drugs: Biosimilar Biological Products
16-42-25-1. "Biological Product"
16-42-25-4. Substitution; Conditions
16-42-25-5. Records of Dispensing Biologic Product; Time Frame; Exception
16-42-25-6. Record Retention; Pharmacy; Prescribing Practitioner
16-42-25-7. Link to Current List of Interchangeable Biological Products; Rules