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 scientific evidence° 21 U.S.C. 32!(p) and 355: Weinber_qg_
 v. Bentex Pharmaceuticals Inc_ 412 U.S. 645 (1973) o An
 acronym, for this category is _human GRASE drugs _' (Generally
 Recognized As Safe and Effective). These drugs achieve
 acceptance through rigorous scientific proof, through a past
 history of widespread use in treatment in the United States,
 and through recognition by a consensus of drug experts
 outside the FDA_
 Thirds Congress accepted for use in veterinary medicine
 those drugs "generally recognized_ among experts qualified
 by scientific training and experience to evaluate the safety
 and effectiveness of animal drugs, as safe and effective,"
 based on substantial scientific evidence. 21 U.S.Co 321(w)
 and 355o An acronym for these is '_animal GRASE drugs°"
 They achieve acceptance through rigorous scientific evidence
 and through recognition by a consensus of drug experts
 outside the FDAo Unlike human GRASE _rugs_ animal GRASE
 drugs need not have a past history of widespread use.
 Finaliy_ Congress accepted those drugs marketed prior
 to 1938 which had been subject to the 1906 provisions of the
 FDCA_ provided these very old drugs retain their exact
 formulations and are never promoted for new uses° 21 U.SoC.
 321(p) and (w). These are politically "grandfathered"
 drugs_ They need not meet modern standards for safety and
 effectiveness.
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