Indiana § 16-42-25-3 "Interchangeable"

Indiana Statutes

§ 16-42-25-3 — "Interchangeable"

Indiana § 16-42-25-3

Title 16HEALTH

Art. 42REGULATION OF FOOD, DRUGS, AND

Ch. 25Drugs: Biosimilar Biological Products

This text of Indiana § 16-42-25-3 ("Interchangeable") is published on Counsel Stack Legal Research, covering Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Ind. Code § 16-42-25-3 (2026).

Text

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.

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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.