norml02 - Page 28

Page 28 Previous , Next , Original Image
Return to Index

 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) .
 Petitioners claim that the scheduling decision was
 procedurally flawed because the Administrator based his finding

Previous , Next , Return to Index