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 require a past history of use in treatment to show safety and
 effectiveness. Final Order ii_ 57 Fed. Reg. at i0_506. The
 Administrator has also clarified that recognition of the drug's
 clinical use in generally accepted texts is not a distinct
 requirement in his analysis° Id.
 in the interest of clarity and brevity_ the Administrator has
 subsumed former factor 7 and the part of factor 8 concerning
 "recognition of the substance by a substantial segment of the
 medical practitioners" into the requirement that a consensus of
 qualified experts accept the drug for medical use. I d. at
 I 10,505. This requirement applies only to drugs_ such as
 I marijuanas with no approved NDA. A drug with an approved NDA
 would already have been evaluated by _
 _xper_s for safety and
 I See 21 U.S.Co 355(d) (1988). The
 has also determined that the drugCs recognition in generally
 accepted texts is sufficient evidence ore but not prerequisite
 I to, scientific knowledge of the drug's chemistry° Final Order
 If, 57 Fed° Reg. at 10,506. When expert consensus is required_
 I however_ the Administrator has determined that information about
 the substance "must be reported, pub!ished_ or otherwise widely
 available, in sufficient detail to permit experts to fairly
 1 conclude the substance is safe and effect_ve for use in treating
 a specifics recognized disorder. _ Id. (citing _Qoper
 Laboratories Inc. v. FDA_ 501 F.2d 772{ 786 (D.C. Cir° 1974) °
 The record supports the Administrator's conclusion that Final
 Order I did not rely on the impermissible factors°

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