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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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 Nebraska Statutes 38-2818.02