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

Indiana Statutes

§ 16-42-25-3 — "Interchangeable"

Indiana·Title 16 HEALTH·Art. 42 REGULATION OF FOOD, DRUGS, AND·Ch. 25 Drugs: Biosimilar Biological Products

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.

Indiana § 16-42-25-3 ("Interchangeable") — published by Counsel Stack Legal Research, free access to 12M+ legal documents.