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 disorder_ This is an essential aspect of whether a drug has
 currently accepted medical use. Rather than standing alone_
 this requirement will be more clearly understood by
 incorporating it into the other critical elements.
 To summarize, the five necessary elements of a drug
 with currently accepted medical use in treatment in the
 United States are:
 (i) e____t's Chemistry Must Be Known and
 Reproducible
 The substanceWs chemistry must be scientifically
 established to permit it to be reproduced into
 dosages which can be standardized. The listing of
 the substance in a current edition of one of the
 official compendia_ as defined by Section 201(j)
 of the Food, Drug and Cosmetic Act, 21 U_S.C.
 321(j)_ is sufficient generally to meet this
 requirement.
 (ii) There Must Be Ade_Saf_y___udies
 There must be adequate pharmacoiogical and
 toxicological studies done by all methods
 reasonably applicable on the basis of which it
 could fairly and responsibly be concluded, by
 experts qualified by scientific training and
 experience to evaluate the safety and
 effectiveness of drugs, that the substance is safe
 for treating a specifics recognized disorder.
 (iii) There Must Be Ade ate and Well_Controlled
 Studies provinq_Efficac Z
 There must be adequate_ well-controlled, well-
 designed, well-conducted and well-documented
 studies, including clinical investigations_ by
 experts qualified by scientific training and
 experience to evaluate the safety and
 effectiveness of drugs on the basis of which it
 could fairly and responsibly be concluded by such
 experts, that the substance will have its intended
 effect in treating a specifics recognized
 disorder.
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