norml08 - Page 32
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To be GRASE, a drug must be '_generally recognized _
among experts as safe and effective for its intended use.
The drug must be known or familiar to the national community
of relevant experts° United States v. Articles of
Druq_ooFUrestrol _qinai Sup_ositories, 294 F_ Supp. 1307,
1309 (NOD. Gag 1968) aff_d, 415 F.2d 390 (5th Cir. 1969).
To determine if a drug is known to the community of experts_
courts have looked to whether there is widely available
scientific literature about the drugs Premo Pharmaceutical
Laboratories_ Inca v. United Statesf 629 Fo2d 795t 803 (2d
Cir. 1980), whether it is widely taught in medical schools;
Lemanon Pharmaceuticals Co. Vo Richardson, 3i9 F. Supp. 375,
378 (EoD_ Pa. 1970)_ and whether it is widely discussed by
experts. United States v. Bentex Ulcerine, 469 Fo2d 875,
880 (5th Cir. 1972).
The recognition of a drug as GRASE need not be
universal° General recognition is sufficient° United
Stats v. 41 Cartons...Ferro-Lac_ 420 F.2d 1126, i132 (Sth
cir. 1970)_ The Supreme Court has interpreted this to mean
a consensus of experts is familiar with and accepts a drug
as safe and effective. W einber_er v. _Hy_Dson_ Etc_ 412 U.S°
609_ 629 (1973). However, if there is a serious dispute
among the experts_ a drug cannot be considered GRASE.
Unitedstar_ es v. An Articleo___ Food_.oCOCO Rico_ 752 F.2d
llf 15 (lst Cir. 1985); Merrit Corp__v.Fol___som_ 165 Fo Supp.
............. , 418f 421 (D.D.C_ 1958)o
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