norml09 - Page 37

Page 37 Previous , Next , Original Image
Return to Index

 treatment° i conclude that the general availability of a
 drug is irrelevant to whether it has a currently accepted
 medical use in treatment within the meaning of the
 Controlled Substances Act.
 Go _9co n't'Oo in General _ Accep_e_.__X_.s__/_
 Point five of the eight-point test deals with
 _'recognition of its clinical use in generally accepted
 pharmacopeia, medical references_ journals or textbooks. '_
 The listing of a drug in an official compendium is
 sufficient to show its chemistry is scientifically
 established. This appears in my clarification to point one.
 The requirement that information concerning the chemistrye
 pharmacology; toxicology and effectiveness of the substance
 be reported_ published or otherwise widely available, is
 explained adequately in revised point four. To the extent
 the scheduling of a drug directly influences its recognition
 in publications_ this element is subject to the same
 criticism identified by the Court of Appeals concerning
 point four° Therefore, this should not be treated as a
 distinct requirement.
 Ho Se_ic_Reco_zed Disq_/!ers Are the Referent.
 It is impossible to judge the _afety and effectiveness
 of a drug except in relation to a specific intended use. A
 drug cannot obtain NDA approval or GRASE status except in
 relation to the treatment of a specifics recognized

Previous , Next , Return to Index