norml09 - Page 26
Page 26
Previous ,
Next ,
Original Image
Return to Index
to describe drugs with currently accepted medical uses°
54 FR 53783 (December 29, 1989):
l. Scientifically determined and accepted knowledge of its
chemistry;
2o The toxicology and pharmacology of the substance in
animals;
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
textbooks;
6_ Specific indications for the treatment of recognized
disorders;
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
States.
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
26
Previous ,
Next ,
Return to Index