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 !. FFedersi R_|stvr / Vo|. 5I, No+ 1_ / Tuesday. October _4+ 1_ / Rules arid Regulations 36555
 k evat_tee the safety and efficacy _f phenylisopropy|amtne$ or mood or mental state. The terms
 _.lgs to conclude that the literah_re amphetamines, psycho_omimetic and ha|lucinogeni˘ are
 deas nol support the safety of MDMA 2_. MDA. o_ 30++ commonly used inteschangeab|yo
 ..... for use under medical suporvlsion, melhytenedioxyamphetamine0 2S. MDMA is the N-methyl analog of
 1& On June 29, 1982, the Food end amphetamine end methamphetamlne MDA. This means that MDMA differs
 Drug Adminlstretion (FDA) published in ape R|so phenyllsopropylamlnee, structural|y from MDA the same way
 the Federal Rebates "Proposed 2_o MDA+ or 3,@ Lhat methamphetemine differs from
 Recommendations to the Drug methy|enedio×yamphe_amine, i, formed amphetamine, by the addition of an N-
 FK_foreement Administration Regarding by the addition of a methylenedioxy methyl group+
 _he Scheduling Status of Marihtmna end grosp to amphetamine. _. N-methylation of MDA yields
 I_ CComponen_ and Notice of a Publ|c _. MDMA i_ formed by the ed_tlon MDMA which retains the
 Hearing _' (47 FR _14_] in which the of a methyienedioxy group _o psychotomimetic properties of MDAo
 Commissioner of Food and Drugs stated: _etha_phetamineo _7. N-methylstion of amphetamine
 The Federal Foo(L Drug end Cosmellc A_ _. The addRio_ of a methylenedlo_y y_e|de methamphetamine which retains
 ! ptovid_ ttmt FDA approve sn NDA upon _'oup to the aromatic nucleus st the central nervous system activity of
 _˘i_tific evidence the_ the drug has heart amphetamines prodttces compounds amphetamine.
 i shown to be safe and effective for it+ with psychotomirnettc activity. 28_ The difference in structure
 proposed uses. See _ UoS. Co 385{dl. _ecsu_e 2_o Psychotnmimetic is a term used to between amphetamine and
 _o ˘l_ug ie ever completely +ale in the describe a large c|ess of compounds methamphetamine i+ illustrated by the
 :-- I ,_b_Ime sense, FDA coe+_ders "safe" _o which change or modify a perch's fo_ow_ng _agrar˘
 moan {in the context of _ human dru$_ the!
 _her_pc_tlc _efits _o be de_ve_ from
 : _u_ drug ostwe_gh _ts known _nd potentia_
 +-+++°+°°+°+++ CY+
 CH_" H-._ 2 CH 2- H-I_CM_
 A_totheP fUCIOr considered by F_A tR
 _ing the drug's safety te the p_posed +
 CH 3 + C_
 hireling which is approved _ the time of
 _ppt,svei for _rmrket_ng. A drt_ might be
 _nsidemd safe for some proposed _s beat
 sot others. Only those proposed use, where
 bonsai/risk eati_ t_ favorabM _i_l be a_tt_ha˘_tm_ _e t_e_h_._phet, a_ na
 included in the indte_tion, section of the
 ˘_m$'sl_be_in_.o. 29+ The _Ifferen:e _ _tr_:t_rs between MDA and HDMA is
 _t it is only upon approval for ma_e_ir,_
 wt_e_hasbe_n_min_fitutionald, e_m_n i_,_uat, rated by _he folXowlng dt._gr_m::
 bwmml tim _c_tit_c judgement by the
 _eto_ agency chap with the
 _por_ibility of evaluating the aafeW _d _ _ 0 _ 0
 "accepted" am eefe under readiest ' "
 _& Thece is no legitimate comme_'cial
 _tacturer of MDMA in the United C_3 CH3
 _tete& Further, the MDMA which hen
 been used by psychiatrist+ is not _abeted
 with safety or therapeutic _DA HDHtt
 1_. _e PMSSa '+accepted safety for _. MDMA produces phsrmacolosical with results of tests in _ce of
 see +.. under medical supervision" aa effete in common with beth central amphetamine compounds with no ring
 u_ei in gl U.S.C. 8_2(b) means that a nervous system ,timul_nt_ like s_bstitution (e.g, amphetamine and
 d._ 8 has been evaluated for safety by amphetamine, and ha|luclno_ens Like m_thsmphetamine)+ Braun, Shulgin and
 tim Food and Dru 8 Administration and MDA in soLes|s+ Braun further conclude that "compour_ds
 spp_ved for marketing in the United _1_ MDA and MDMA both produce which csuse a sharp increase in motor
 _ate_ cen_al nervous system stimulation _a activity in animals generally prove to
 _& Accordingly, the Administrator measured by increased locomotor hove e pronounced central nervous
 R._ds that since MDMA has not been activity in mice+
 evaluated for safety by the Food and 32+ Tests conducted by Bra_+ Shulsin system effect in mar."
 Dra8 Administration. and ha, not been sod Braun show that iI an oral dose of _, A study conducted by Intox
 app_ved for marketff_3 in the UPJted 20 m_./k_o in mice, MDA produced _ Laboratories reported si_iflc_ntly
 elates, it does not possess "accepted si_lfic_nt increase in locomotor reduced body weighta et 7 and 14 de}',
 _fety for use. o + under medi_i IctivlW, At the same done+ MDMA fultowi_,_ initiation of MDMA dosing in
 mq_rv_siom" produced approximately three times the rots.
 19. MDNL_L or 3,_ motor activity of MDA duri_ the fat _+ The _tox Laboratory study also
 tm_thyienedioxymethamphetamine, three hoers after app|icatton_ They repeated that rats who had been
 belongs to a class of compounds which concluded that MD_. MDMA and M+ administered MDMA showed
 can be termed phenethyleminee or, ethyl MDA caused the greete+t hyperactivity, excitability, a88re_iva
 mmmwiy definecL s_imuia_on _nd _hat this is consistent behavior and stereotypic behavior.

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