OAR 855-041-1001
Definitions
(1)
“Biological product” means, with respect to the prevention, treatment or cure of a disease or condition of human beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, blood derivative, allergenic product, protein other than a chemically synthesized polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic compound.(2)
“Biosimilar product” means a biological product licensed by the United States Food and Drug Administration pursuant to 42 U.S.C. 262(k)(3)(A)(i).(3)
“Drug room” is a drug storage area registered with the Board which is secure and lockable.(4)
“Interchangeable” means, in reference to a biological product, that the United States Food and Drug Administration has determined that a biosimilar product meets the safety standards set forth in 42 U.S.C. 262(k)(4).(5)
“Reference biological product” means the biological product licensed pursuant to 42 U.S.C. 262(a) against which a biological product is evaluated in an application submitted to the United States Food and Drug Administration for licensure of a biological product as a biosimilar product or for determination that a biosimilar product is interchangeable.
Source:
Rule 855-041-1001 — Definitions, https://secure.sos.state.or.us/oard/view.action?ruleNumber=855-041-1001
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