38-2807.01. Bioequivalent, defined.
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/ne/chapter-38/38-2807-01A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.