norml08 - Page 36

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 Under the FDCA, a human GRASE drug must have a material
 history of past use in treatment in the United States°
 21 U.SoC° 321 (p) (2) (which has.°°, otherwise than in such
 investigations, been used to a material extent or a material
 time); Weinbe_qer v. _____l___tCo6 412 U.S_ 609f 631 (1973).
 Rigorous scientific proofs and current unanimous acceptance
 by the medical and scientific community are not enough for a
 human drug to be GRASE° Tri-Bio Labs__. Inco Vo_Un_ed
 States., 836 F.2d 135_ !42 no8 (3d Cir. 1987). The general
 availability of a drug for use in treatment is a factor
 courts have considered to determine if a human drug is
 GRASE.
 in contrasts a drug can achieve current acceptance for
 ...:,.:...
 /:.
 human medical use through the NDA process without a past
 history of use in treatments Also_ animal drugs can become
 accepted as GRASE without any past history of medical use.
 Given this conflict in FDCA standards, which did Congress
 choose when drafting the CSA?
 As the Court of Appeals points out, requiring a
 material history of past use in treatment before recognizing
 a drug as having a currently accepted medical user would
 permanently freeze all Schedule I drugs into Schedule I.
 930 F.2d at 940° Clearly, Congress did not intend this
 results Moreover, the use of the word _currently _' before
 the term '_accepted medical use '_ would indicate Congress
 ......... rejected the human GRASE requirement of past material use in
 /. •
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