norml08 - Page 39

 '_ .............
 (iv) The Drug Must Be Ac_ted by__Qualified
 Exerts
 The drug must have a New Drug Application (NDA)
 approved by the Food and Drug Administration,
 pursuant to the Food, Drug and Cosmetic Acts
 21 UoS_Co 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 specific, recognized disorder_ A material
 conflict of opinion among expe_s precludes a
 finding of consensus.
 (v) The Scientific Evidence Must Be Wide!x
 Available
 In the absence of NDA approval, information
 concerning the chemistry, pharYL_acology_ 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 specific,
 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
 clarity, let me emphasize those proofs that are irrelevant
 to the determination of currently accepted medical use, and
 that will not be considered by the Administrator:
 (i) Isolated case reports;
 (ii) Clinical impressions of practitioners;
 (iii) Opinions of persons not q_alified 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
 i!"
 preclude responsible scientific evaluation;
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