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 to describe drugs with currently accepted medical uses°
 54 FR 53783 (December 29, 1989):
 l. Scientifically determined and accepted knowledge of its
 2o The toxicology and pharmacology of the substance in
 3_ Establishment of its effectiveness in humans through
 scientifically designed clinical trials;
 4. General availability of the substance and information
 regarding the substance and its use;
 5o Recognition of its clinical use in generally accepted
 pharmacopeia, medical references, journals or
 6_ Specific indications for the treatment of recognized
 7. Recognition of the use of the substance by
 organizations or associations of physicians; and
 8. Recognition and use of the substance by a substantial
 segment of the medical practitioners in the United
 Some uncertainty remains over the precise meaning and
 application of parts of this test° Thereforev the Court of
 Appeals for the District of Columbia Circuit remanded these
 proceedings for a further explanation. In addition to
 addressing those parts of the test that concerned the Court
 of Appealsv it would be useful to clarify the entire test,
 pinpoint its origins, and identify which elements are both
 necessary and sufficient to establish a prima facie case of
 currently accepted medical use. This is not an effort to
 change the substantive iaw_ The statutory meaning of
 currently accepted medical use remains the same as enacted

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