Nebraska Statutes 38-2825.02. Interchangeable biological product, defined
Interchangeable biological product means a biological product that the federal Food and Drug Administration:
Terms Used In Nebraska Statutes 38-2825.02
- 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
- Equivalent: means drug products that are both chemically equivalent and bioequivalent. See Nebraska Statutes 38-2821.01
- Interchangeable biological product: means a biological product that the federal Food and Drug Administration:
(1) Has licensed and has determined meets the standards for interchangeability pursuant to Nebraska Statutes 38-2825.02
(1) Has licensed and has determined meets the standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), as such section existed on January 1, 2017, or as set forth in the Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations published by the federal Food and Drug Administration, as such publication existed on January 1, 2017; or
(2) Has determined is therapeutically equivalent as set forth in the Approved Drug Products with Therapeutic Equivalence Evaluations of the federal Food and Drug Administration, as such publication existed on January 1, 2017.