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 i Fedora| Register / VoL 51, Nee 198/Tuesday, October 14, I_ / Rules and Regu|ations 36559
 THe avai|sb|e scientific da|a clearly distributlon of MDMA continues i_ Instructiona| activities with respect to
 show that MDMA produces physical Ca_adao The Federal l_epublic of this substance, or who proposes to
 end psychologic,s! effects in common Germany haa _,_so reported the engage in each activities0 must be
 ..... with central nervous system stimulants clandestine manufacture end registered to conduct such activities in
 like amphetamine, and w_th known distr_.bu_on of MDMA. accordance with Parts 1301 end 131I of
 hs|Jucinogens or psychotomimetics like The Administrator has read with Title 2I of the Code of Federal
 MDA in both animals and human_o The Interest the comments from various Regulations.
 chemical sLrccture of MDMA is very parties ia the record concerning what Z. Security. MDMA must be
 closely related to MDA and _o affect p_acement of MDMA into manufsctured_ distributed and stored in
 msthamphetamineo Its pharmacological Schedule | would have on lagitlma_e accordance with §§ !301.71 through
 pmpertles are almost identical to those research into the substance° 1301o7S of Tiffs _i of the Code of Federal
 ..... af MDA. In preliminary studies, N_DMA The Cos_rolled Substances Act Regulations°
 has been shown to be neurotoxtc _ contains specific pzovisions for research 3. L_be//_ and Pockog/_g, Al| labels
 animals, Just as MDA has been _howz_ with Schedule _ substances. _ and IzbeIing for commercial contaisers
 : to bs aeurotoxico In the studies registration provisions are found in 21 of MDMA must comply with the
 _ conducted specifically to determine U.SoCo 823(_. The _aj_ difference _ the requirements of § § 130Z.03 through
 _bu_e liability, MD_A has been shown rafts|story requirements imposed upon _302o05. 130_.7 end _1302.08 of Title 21 of
 to have an abuse liability similar _o researchers ha_dlln_ Schedule I the Code ot Federal Regulations.
 stimulants such as cocaine and controlled substances and those ,_o _u_taso All persons required to
 ' _mphetamisa. both substances w_h an conducting research with Schedule [I. obtain quotas for MDMA sha_l submi_
 established high potential for abuse. I_L _V and V cow.oiled substances is applicefiona pursuant to § § 1303._ and
 MDMA i_ a substance which is the _egi_tration requirements which _303o2_ ofTit|a 2_ of the Coda o_ Federal
 c_ssdest_nely produced and trafficked require review of a protocol by the Reg_datioas.
 on the street in the UnRed States, and is Secretary of the Depa_ment of Heahh 5o inventory. Every registrant required
 taken for its pleasurable effects, and Human SeP_ice_. _o keep records and who possesses any
 A_imal and human studies which = The information required to be quantity of MDMA shall take an
 comp|etely characterize the contained in this protocol is oudined lnveoto_ pursuant to 130_o11
 pharmacology, safety and efficacy of with specificity in _'I CFR _1301.33. The through1304.!9 of Title _I of the Code of
 MDMA are not available, protocol requirements also make Federal Regulations of all stocks of this
 The Administrator finds that the r_forence to the investigationa_ new substance on hand.
 Agency sustained its burden that drug (IND) _rocedureso They provide •
 MDMA has a high potential for abuse. |t mechanism for researchers wishin_ _o 6. l_ecot_i_. All re_istrrsnts required to
 has a similar chemica_ structure and conduct clinical (human) _nvesti_ation_ keep records pursuant to 130_.21-_301o_7
 pharmacological properties nearly with controlled substances is Schedui_ of Title _I of the Code of Federal
 identical to substances already found to L Regulations shall do so regarding
 have a high potential for abuse. It is Al_ researche_ utfllzis s controlled MDM.A_
 _ndestinely manufactured, trafficked, substances must be registered by the 7_ Repo_. All registrants required [o
 _d actually abused° Its lack of Drug F._'Jorcement Administret[or_ All submit reports pursuant to §§ 1304.27
 established safety and potenfla| researchers must keep records, end all through 1304.41 of Title 21 of the Code of
 neurotoxicity make it a serious risk t_ researchers mu_ maintain the Federal Regulations shall do so
 the public health and safety, controlled substances in a "securely regarding MDMAo
 Because the Administrator has found locked_ substantially constructed 8o O_Jee Forms. All registrants
 that MDMA has no accepted medical cabinet." The records required to be involved in distribution of MDMA shall
 ,. see in treatment and has a high kept by researchers in Schedule _ are comply with the order form
 _ential for abuse, it is unnecessary to not substantially different from the requirements of § § 1305.01 through
 address the issue of "whether a dcug records required to b_ kept by a 1305.18 of Title 21 of the Code of Federal
 which has potential for abuse but no researcher or dispen_a:r of Schedule IL Regulations.
 _rrently accepted medical use m [II, tV or V controlled substances. @. L,r_port_t/on ¢mdExpoz'tc_tion. All
 A review of the abov_ regulations
 |tape,orion and exportation of MDMA
 treatment can lawfully be placed in any demonstrates that those who wish to shall be in compliance with Part _I_ of
 schedule other than Schedule L °°
 conduct research with MDMA have
 In reaching the conclusion that available avenues by which to pursue Title _'I of the Code of Federal
 MDMA should be placed in Schedule _ such research. Re_ulatlonso
 d the Controlled Substances Acl, the Placement of s substance into _0o Ceim/n_] A/ability. Any activity
 Administrator has a]ao considered the Schadule _ end desi_atJng it as s with respect to MDMA not authoM_ed
 to|lowing isformat_on. [n 1983, the hallucinogenic imposes certain by, or in violet/on of, the Controlled
 World Health O_anization regulatory requirements on _hose Substances Act or the Controlled
 recommended that MDMA be placed in handling the _ub_tsnce. Since I_/DM.A Substances _mpor_ and Export Act
 Schedule I of the Convention on has been a Schedu|e _ controlled continues to be unlawful. The cMminal
 Psychotropic Substances (CPS), _1, substance since |u_y L 198._, the penalties am those of e Schedule l
 sad the United Nations Con_nisaion on requirements tmposad by the CSA and ha|lucinogenic.
 Narcotic Drugs subsequently placed implementing regulations continua as Pursuant to 5 U.S.C. 605(b]. the
 MBMA in Schedule L follows: Adn_dnistretor certifies that the
 Is addition, MDMA is controlled in L Restitution. Any pecan who placement of MDMA into Schedule I of
 _c_edule H of the Canadian Food sad manufactures, distributes, delivers, the Controlled Substances Act will have
 Drug Act, along with MDA and LSDo imports or e_ports _M,at_ or who no impact upon small businesses or
 Reports of clandestine manufacture and engages in research or conducts other entities whose interests must be

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