Sec. 199. “Legend drug”, for purposes of IC 16-42, means a drug that is:

(1) subject to 21 U.S.C. § 353(b)(1); or

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Terms Used In Indiana Code 16-18-2-199

  • United States: includes the District of Columbia and the commonwealths, possessions, states in free association with the United States, and the territories. See Indiana Code 1-1-4-5
(2) listed in the Prescription Drug Product List as:

(A) published in United States Department of Health and Human Services Approved Drug Products with Therapeutic Equivalence Evaluations, Tenth Edition, (1990); and

(B) revised in United States Department of Health and Human Services, Approved Drug Products with Therapeutic Equivalence Evaluations, Cumulative Supplement to the Tenth Edition, Number 10 (1990).

[Pre-1993 Recodification Citations: 16-6-8-2(k); 16-6-12-3.]

As added by P.L.2-1993, SEC.1. Amended by P.L.131-2014, SEC.6; P.L.10-2020, SEC.1; P.L.9-2024, SEC.370.