Nebraska § 38-2807.01 Bioequivalent, defined

Nebraska Statutes

§ 38-2807.01 — Bioequivalent, defined

Nebraska § 38-2807.01

Ch. 38Health Occupations and Professions

This text of Nebraska § 38-2807.01 (Bioequivalent, defined) is published on Counsel Stack Legal Research, covering Nebraska primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Neb. Rev. Stat. § 38-2807.01 (2026).

Text

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.

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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.

Legislative History

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.