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§ 16-42-25-3 — Indiana Law | CourtGPT
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  4. Title 16 - Health/
  5. Article 42 - Regulation of Food, Drugs, and Cosmetics/
  6. Chapter 25 - Drugs: Biosimilar Biological Products16-42-25-1. "Biological Product"/
  7. § 16-42-25-3
Indiana Legal Code

§ 16-42-25-3

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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.