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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 sum_arize, the five necessary elements of a drug
 with currently accepted medical use in treatment in the
 United States are_
 (i) _h____C_L_q_s Chem _
 t r st e K own a d
 The substance_s chemistry musz 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 Foods Drug and Cosmetic Acts 21 U.S.C.
 321(j)_ is sufficient generally to meet this
 requirement°
 (ii> _st Be Ade_t_es
 There must be adequate pharmacological and
 toxicological studies done by all methods
 reasonably applicable on the basis of which it
 couid 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 specific, recognized disorder°
 (iii) There Must Be Adequate and Well-Cont o led
 Studies Provinq_Effica_
 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 specific, recognized
 disorder.
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