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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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