norml09 - Page 37
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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__/_
rclot.
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
37
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