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 ....... :x, 7-5007 {_pr' 26,9I 12:56 No.O05 p.09
3 POLICY FOUNDATION TEL:zu_:__
 9
 Schedule jl is to raise significant barriers to prevent doc-
 ,ors from ob_.aining the drugs zoo easily. DEA regulations
 require doctors who wish to use such drugs t.o submit a
 scientific research protocol {.o the FDA for approval and
 permit use only in accordance with the protocol. And t,he
 FDA insists that, a developed scientific study program be
 presented in order to gain approval of t.he protocol. See
 21 C.F.R.  1301o33(b} (requiring compliance with 21
 C.F.R.  130.3L The DEA regular.ions furt.her impose
 mandatory regis_.ration with the DEAf and mandatory
 record-keeping and sa/_keeping requirements, presenting
 additional barriers to widespread use: see 21 C.F.R.
  t301.33, t301.42. We are therefore hard-pressed to
 understand how one could show that any Schedule ! drug
 was in general use or generally available. We are also con-
 cerned ihat the fifth factor "recognition o5 [a drug's] clini-
 cal use in generally accepted pharmacopeia, medieai
 reierences, journals, or t ex,.books" migM. be subject to _he
 same o}_iection. Petitioners assert that i:_ a drug is not:
 widely prescribed--regardiess of" its safety or use---h, vdil
 not appear in a pharmaceut, ical tisting of medically usefui
 drugs. Since die government did not respond clearly _o
 _i_e artgument, we are lel_ i_ doubt as ,o ,he argument's
 vaiidhyo Under these circumstances, we think the appro-
 priate course is zo remand 1o the agency for an explana-
 ,ion as to how alt _hree of these faclors we. re utilized by
 _.he Administrator in reaching }_is decisiora. *
 To be sure, _he Administ. rator did not explicitiy rely on
 fact.ors (4) and {8) in _he analytical portion of his opinion
 (he did say "marijuana is not recognized as a rnedieine in
 generally accept.ed pharmacopeia, medical rei_rences: and
 textbooks," indicating his reliance on !_ctor (5}), BuS
 since he did reaffirm the eigl_t criteria's applicability to
 this case, we simply caroms, be certain what, role, if any,
 4Petitioners also quarrel wit.h the Administrator's deeisi(m that
 marijuana lacks "accepted satety for use." Since the Administrator
 based this determina_Mn on his decision t. hat no medical uses are
 possible (and thus any use lacks "accepted safety"}, we do mot see
 l_hat %afety" issue as raising a separate analytical questioa_.




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