norml09 - Page 36

 Under the FDCA_ a human GRASE drug must have a material
 history of past use in treatment in the United States.
 21 U_SoCo 321 (p)(2) (which has .... otherwise than in such
 investigations_ been used to a material extent or a material
 time); W einbe___qer vo Hyn_on_., 412 UoS. 609_ 631 (1973)o
 Rigorous scientific proofs and current unanimous acceptance
 by the medical and scientific community are not enough for a
 human drug to be GRASEo ___-Bio LabsInc. vo United
 States, 836 F.2d 135, 142 n.8 (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 contrast, a drug can achieve current acceptance for
 human medical use through the NDA process without a past
 history of use in treatment. 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 usep would
 permanently freeze all Schedule ! drugs into Schedule I.
 930 Fo2d at 940. Clearly, Congress did not intend this
 result. 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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