Nebraska Statutes 38-2807.01. Bioequivalent, defined
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Bioequivalent means drug products: (1) That are legally marketed under regulations promulgated by the federal Food and Drug Administration; (2) that are the same dosage form of the identical active ingredients in the identical amounts as the drug product prescribed; (3) that comply with compendial standards and are consistent from lot to lot with respect to (a) purity of ingredients, (b) weight variation, (c) uniformity of content, and (d) stability; and (4) for which the federal Food and Drug Administration has established bioequivalent standards or has determined that no bioequivalence problems exist.
Source
- Laws 1977, LB 103, § 2;
- Laws 1983, LB 476, § 21;
- Laws 1989, LB 342, § 36;
- Laws 1996, LB 1044, § 720;
- Laws 1998, LB 1073, § 148;
- Laws 2001, LB 398, § 76;
- Laws 2003, LB 667, § 15;
- Laws 2005, LB 382, § 11;
- Laws 2007, LB296, § 622;
- Laws 2007, LB463, § 1232;
- R.S.1943, (2009), § 71-5402;
- Laws 2015, LB37, § 61;
- R.S.1943, (2016), § 38-28,110;
- Laws 2017, LB481, § 3.
Terms Used In Nebraska Statutes 38-2807.01
- Administration: means the act of (1) administering, (2) keeping a record of such activity, and (3) observing, monitoring, reporting, and otherwise taking appropriate action regarding desired effect, side effect, interaction, and contraindication associated with administering the drug or device. See Nebraska Statutes 38-2807
- Bioequivalent: means drug products: (1) That are legally marketed under regulations promulgated by the federal Food and Drug Administration. See Nebraska Statutes 38-2807.01
- Drug product: means any drug or device as defined in section 38-2841. See Nebraska Statutes 38-2818.02