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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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