Nebraska Revised Statute 38-2807.01
- Revised Statutes
- Chapter 38
- 38-2807.01
Chapter 38
38-2807.01.
Bioequivalent, defined.
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.