vol1 - Page 80
Page 80
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therefore, no longer lacks sufficient safety Hunder medical
supervisions" it must be reclassified as a Schedule II drug.
\
On two occasions, the Drug Enforcement Administration
("DEA H) has defined _currently accepted medical use in treatment
in the United States" with reference to the Food and Drug
_
Administration's new drug application (_NDA #) approval process°
Initially_ DEA required that a drug with a mcurrent!y accepted
medical use in treatment in the United States N must have first
receivedNDA-approval from FDA. _Q/ After this standard was
rejected by a unanimous panelof the United States Court of
Appeals for the First Circuits 21/ and after the evidentiary
record in this proceeding was closed_ DEA promulgated a new_
amorphus standard that appears to again condition compliance with
the #accepted medical use in treatment in the United States"
requirement upon satisfying the NDA-approval standard. 2_/ As
will be discussed in greater details inf_, if this is a correct
readingp the wnew standard" offered by DEA is invalid and thus
......
nat binding upon this proceeding.
Likewise_ DEA has, on two separate occasions, defined
_safety w with reference to the NDA approw_l process° Although
• ..... 20/ 51 Fed° Reg. 36.552 (1986).
21/ G rinspoon V. Drug Enforcement Admin_L, 828 F.2d 881 (let
Cir. 1987). The court was nloatheH to accept DEA's standard and
characterized DEASs standard as _disingenuous. # /__. at 888.
2_/ 53 Fed. Reg. 5156 (1988).
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