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 (iv) _Lq_/_ust_._cq_tedb_ualified
 The drug must have a New Drug Application (NDA)
 approved by the Food and Drug Administrations
 pursuant to the Food, Drug and Cosmetic Act.
 21 U.S_C. 355_ Or, a consensus of the national
 community of experts, qualified by scientific
 training and experience to evaluate the safety and
 effectiveness of drugs, must accept the safety and
 effectiveness of the substance for use in treating
 a specifics recognized disorder° A material
 conflict of opinion among experts precludes a
 finding of consensus°
 (v) T Scie tif_cl viden_e M_/st_el_
 In the absence of NDA approvals information
 concerning the chemistry_ pharmacology_ toxicology
 and effectiveness of the substance must be
 reported_ published, or otherwise widely available
 in sufficient detail to permit experts, qualified
 by scientific training and experience to evaluate
 the safety and effectiveness of drugs, to fairly
 and responsibly conclude the substance is safe and
 effective for use in treating a specifics
 recognized disorder.
 Together these five elements constitute prima facie
 evidence that a drug has currently accepted medical use in
 treatment in the United States. In the interest of total
 clarityp let me emphasize those pro;ors that are irrelevant
 to the determination of currently accepted medical user and
 that will not be considered by the Administrator:
 (i) Isolated case reports;
 (ii) Clinical impressions of practitioners;
 (iii) Opinions of persons not qualified by
 scientific training and experience to evaluate the
 safety and effectiveness of the substance at
 issue;
 (iv) Studies or reports so lacking in detail as to
 preclude responsible scientific evaluation;
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