norml08 - Page 37
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.
G. Reqg_qDitio_n inG___enerally_ Accepted Texts Is
!rre!gvant o
Point five of the eight_point t_st 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 infor_ation concerning the chemistry,
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_
H. s_cif_c__co nixed Disorders Are the Referento
It is impossible to judge the safety 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 specific, recognized
37
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