norml02 - Page 28
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Rego at i0_504o Contrary to petitioners' reasonings this factor
does not constitute the kind of "impossible requirement" that
this court found _perforce unreasonable _' in ACT v. DFEA. See 930
I Fo2d at 940_ There_ the court was concerned with requirements
that no Schedule I drug could ever fulfill° See id.
Admittedly_ the marijuana plant does not lend itself readily
to compliance with research requirements respecting
investigational drugs under the FDCA or Schedule I substances
under the Controlled Substances Acts This fact alone, however,
does not render those requirements unlawful. Petitioners cite to
I regulations that permit the FDA to waive application requirements
such as adequate and controlled studies of the drug when, among
other circumstances_ an applicant successfully explains why
"compliance with the requirement is unnecessary for the agency to
evaluate the application or compliance cannot ]De achieved." 21
CoF.R. 314_90_ See also 21 C°FoR. 314oi26(c). It seems
unlikeiy_ however, that the kind of evidence submitted by
petitioners in the administrative proceedings below would be
adequate to secure such a waiver° It is also significant that
nothing in those provisions appears to permit waiver of the
requirement that "the test drug be standardized as to identity,
strength, quality, purity, and dosage formo" 21 CoF.R.
314. 126(d) .
B. THE ADMINISTP_TOR_S FINAL ORDER IS NOT PROCEDURALLY
DEFECTIVE.
Petitioners claim that the scheduling decision was
procedurally flawed because the Administrator based his finding
22
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