norml09 - Page 22
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scientific evidence. 21 UoS.Co 321(p) and 355;
v. Bentex Pharmaceuticals, Incur 412 U_So 645 (1973). An
acronym for this category is _human GRASE drugs 't (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 Statesf
and through recognition by a consensus of drug experts
outside the FDA.
Third, Congress accepted for use in veterinary medicine
those drugs "generally reccgnized_ 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 UpS.Co 321(w)
and 355. An acronym for these is _'_nimai GRASE drugs."
They achieve acceptance through rigorous scientific evidence
and through recognition by a consensus of drug experts
outside the FDA. Unlike human GRASE drugs_ animal GRASE
drugs need not have a past history of widespread use°
Finally, Congress accepted those drugs marketed prior
to 1938 which had been subject to tlhe 1906 provisions of the
FDCA_ provided these very old drugs retain their exact
formulations and are never promoted for new uses_ 21 U.S_C.
321(p) and (w)_ These are politically '_grandfathered '_
drugs_ They need not meet modern standards for safety and
effectiveness.
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