New Jersey § 24:6k-1

§ 24:6k-1.

As used in this act: “ Biological product ” means a “biological product” as defined in subsection (i) of section 351 of the

Public Health Service Act ( 42 U.S.C. s.262(i) ), and refers to a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood

component or derivative, allergenic product, protein other than a chemically synthesized

polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine

or any other trivalent organic arsenic compound, applicable to the prevention, treatment,

or cure of a disease or condition of human beings. “ Interchangeable ” means “interchangeable” as defined in subsection (i) of section 351 of the Public

Health Service Act ( 42 U.S.C. s.262(i) ) and indicated as interchangeable by the federal Food and Drug Administration in

the “Lists of Licensed Biological Products with Reference Product Exclusivity and

Biosimilarity or Interchangeability Evaluations,” sometimes referred to as the “Purple

Book.” “ Therapeutically equivalent ” means a therapeutic equivalence rating of “A” has been listed by the federal Food

and Drug Administration in the “Approved Drug Products with Therapeutic Equivalence

Evaluations,” sometimes referred to as the “Orange Book.”