Indiana Code 16-42-25-3. “Interchangeable”
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Sec. 3. As used in this chapter, “interchangeable” means:
(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.
(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
Terms Used In Indiana Code 16-42-25-3
- biological product: means :
Indiana Code 16-42-25-1
- biosimilar: refers to a biological product that:
Indiana Code 16-42-25-2
As added by P.L.96-2014, SEC.6.