[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58601-58604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25227]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Lipomed

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before December 20, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before December 20, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152. Comments and requests for hearings on 
applications to import narcotic raw material are not appropriate. 72 FR 
3417, (January 25, 2007).

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.

[[Page 58602]]

    In accordance with 21 CFR 1301.34(a), this is notice that on June 
18, 2018, Lipomed, 150 Cambridge Park Dr., Suite 705, Cambridge, 
Massachusetts 02140 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance                Drug code      Schedule
------------------------------------------------------------------------
Cathinone.................................            1235            I
Methcathinone.............................            1237            I
Mephedrone (4-Methyl-N-methylcathinone)...            1248            I
N-Ethylamphetamine........................            1475            I
N,N-Dimethylamphetamine...................            1480            I
Fenethylline..............................            1503            I
Aminorex..................................            1585            I
4-Methylaminorex (cis isomer).............            1590            I
Gamma Hydroxybutyric Acid.................            2010            I
Methaqualone..............................            2565            I
Mecloqualone..............................            2572            I
JWH-250 (1-Pentyl-3-(2-                               6250            I
 methoxyphenylacetyl) indole).............
SR-18 (Also known as RCS-8) (1-                       7008            I
 Cyclohexylethyl-3-(2-methoxyphenylacetyl)
 indole)..................................
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)...            7019            I
JWH-081 (1-Pentyl-3-(1-(4-                            7081            I
 methoxynaphthoyl) indole)................
SR-19 (Also known as RCS-4) (1-Pentyl-3-              7104            I
 [(4-methoxy)-benzoyl] indole.............
JWH-018 (also known as AM678) (1-Pentyl-3-            7118            I
 (1-naphthoyl)indole).....................
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)            7122            I
 indole)..................................
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)...            7173            I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-             7200            I
 naphthoyl)indole)........................
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl)            7201            I
 indole)..................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)            7203            I
 indole)..................................
Alpha-ethyltryptamine.....................            7249            I
Ibogaine..................................            7260            I
CP-47,497 (5-(1,1-Dimethylheptyl)-2-                  7297            I
 [(1R,3S)-3-hydroxycyclohexyl-phenol).....
CP-47,497 C8 Homologue (5-(1,1-                       7298            I
 Dimethyloctyl)-2-[(1R,3S)3-
 hydroxycyclohexyl-phenol)................
Lysergic acid diethylamide................            7315            I
2,5-Dimethoxy-4-(n)-                                  7348            I
 propylthiophenethylamine (2C-T-7)........
Marihuana.................................            7360            I
Tetrahydrocannabinols.....................            7370            I
Parahexyl.................................            7374            I
Mescaline.................................            7381            I
2-(4-Ethylthio-2,5-dimethoxyphenyl)                   7385            I
 ethanamine (2C-T-2 ).....................
3,4,5-Trimethoxyamphetamine...............            7390            I
4-Bromo-2,5-dimethoxyamphetamine..........            7391            I
4-Bromo-2,5-dimethoxyphenethylamine.......            7392            I
4-Methyl-2,5-dimethoxyamphetamine.........            7395            I
2,5-Dimethoxyamphetamine..................            7396            I
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)            7398            I
 indole)..................................
2,5-Dimethoxy-4-ethylamphetamine..........            7399            I
3,4-Methylenedioxyamphetamine.............            7400            I
5-Methoxy-3,4-methylenedioxyamphetamine...            7401            I
N-Hydroxy-3,4-methylenedioxyamphetamine...            7402            I
3,4-Methylenedioxy-N-ethylamphetamine.....            7404            I
3,4-Methylenedioxymethamphetamine.........            7405            I
4-Methoxyamphetamine......................            7411            I
5-Methoxy-N-N-dimethyltryptamine..........            7431            I
Alpha-methyltryptamine....................            7432            I
Bufotenine................................            7433            I
Psilocybin................................            7437            I
Psilocyn..................................            7438            I
5-Methoxy-N,N-diisopropyltryptamine.......            7439            I
N-Ethyl-1-phenylcyclohexylamine...........            7455            I
1-[1-(2-Thienyl)cyclohexyl]piperidine.....            7470            I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine....            7473            I
N-Ethyl-3-piperidyl benzilate.............            7482            I
N-Methyl-3-piperidyl benzilate............            7484            I
N-Benzylpiperazine........................            7493            I
2-(2,5-Dimethoxy-4-methylphenyl)                      7508            I
 ethanamine (2C-D)........................
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine            7509            I
 (2C-E )..................................
2-(2,5-Dimethoxyphenyl) ethanamine (2C-H).            7517            I
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine             7518            I
 (2C-I)...................................
2-(4-Chloro-2,5-dimethoxyphenyl)                      7519            I
 ethanamine (2C-C)........................
2-(2,5-Dimethoxy-4-nitro-phenyl)                      7521            I
 ethanamine (2C-N)........................
2-(2,5-Dimethoxy-4-(n)-propylphenyl)                  7524            I
 ethanamine (2C-P)........................
2-(4-Isopropylthio)-2,5-dimethoxyphenyl)              7532            I
 ethanamine (2C-T-4 ).....................
MDPV (3,4-Methylenedioxypyrovalerone).....            7535            I
Methylone (3,4-Methylenedioxy-N-                      7540            I
 methylcathinone).........................
AM-694 (1-(5-Fluoropentyl)-3-(2-                      7694            I
 iodobenzoyl) indole).....................
Acetyldihydrocodeine......................            9051            I

[[Page 58603]]

 
Benzylmorphine............................            9052            I
Codeine-N-oxide...........................            9053            I
Cyprenorphine.............................            9054            I
Desomorphine..............................            9055            I
Etorphine (except HCl)....................            9056            I
Codeine methylbromide.....................            9070            I
Dihydromorphine...........................            9145            I
Difenoxin.................................            9168            I
Heroin....................................            9200            I
Hydromorphinol............................            9301            I
Methyldesorphine..........................            9302            I
Methyldihydromorphine.....................            9304            I
Morphine methylbromide....................            9305            I
Morphine methylsulfonate..................            9306            I
Morphine-N-oxide..........................            9307            I
Myrophine.................................            9308            I
Nicocodeine...............................            9309            I
Nicomorphine..............................            9312            I
Normorphine...............................            9313            I
Pholcodine................................            9314            I
Thebacon..................................            9315            I
Acetorphine...............................            9319            I
Acetylmethadol............................            9601            I
Allylprodine..............................            9602            I
Alphacetylmethadol except levo-                       9603            I
 alphacetylmethadol.......................
Alphamethadol.............................            9605            I
Dioxaphetyl butyrate......................            9621            I
Dipipanone................................            9622            I
Ethylmethylthiambutene....................            9623            I
Etonitazene...............................            9624            I
Etoxeridine...............................            9625            I
Furethidine...............................            9626            I
Hydroxypethidine..........................            9627            I
Ketobemidone..............................            9628            I
Levomoramide..............................            9629            I
Levophenacylmorphan.......................            9631            I
Morpheridine..............................            9632            I
Noracymethadol............................            9633            I
Norlevorphanol............................            9634            I
Normethadone..............................            9635            I
Norpipanone...............................            9636            I
Phenadoxone...............................            9637            I
Phenampromide.............................            9638            I
Phenoperidine.............................            9641            I
Piritramide...............................            9642            I
Proheptazine..............................            9643            I
Properidine...............................            9644            I
Racemoramide..............................            9645            I
Trimeperidine.............................            9646            I
Phenomorphan..............................            9647            I
Propiram..................................            9649            I
Tilidine..................................            9750            I
Para-Fluorofentanyl.......................            9812            I
3-Methylfentanyl..........................            9813            I
Acetyl-alpha-methylfentanyl...............            9815            I
Beta-hydroxy-3-methylfentanyl.............            9831            I
Amphetamine...............................            1100           II
Methamphetamine...........................            1105           II
Lisdexamfetamine..........................            1205           II
Phenmetrazine.............................            1631           II
Methylphenidate...........................            1724           II
Amobarbital...............................            2125           II
Pentobarbital.............................            2270           II
Secobarbital..............................            2315           II
Glutethimide..............................            2550           II
Nabilone..................................            7379           II
1-Phenylcyclohexylamine...................            7460           II
Phencyclidine.............................            7471           II
4-Anilino-N-phenethyl-4-piperidine (ANPP).            8333           II
Phenylacetone.............................            8501           II
1-Piperidinocyclohexanecarbonitrile.......            8603           II
Alphaprodine..............................            9010           II
Anileridine...............................            9020           II
Cocaine...................................            9041           II

[[Page 58604]]

 
Codeine...................................            9050           II
Etorphine HCl.............................            9059           II
Dihydrocodeine............................            9120           II
Oxycodone.................................            9143           II
Hydromorphone.............................            9150           II
Diphenoxylate.............................            9170           II
Ecgonine..................................            9180           II
Ethylmorphine.............................            9190           II
Hydrocodone...............................            9193           II
Levomethorphan............................            9210           II
Levorphanol...............................            9220           II
Isomethadone..............................            9226           II
Meperidine................................            9230           II
Meperidine intermediate-B.................            9233           II
Metazocine................................            9240           II
Methadone.................................            9250           II
Methadone intermediate....................            9254           II
Metopon...................................            9260           II
Dextropropoxyphene, bulk (non-dosage                  9273           II
 forms)...................................
Morphine..................................            9300           II
Thebaine..................................            9333           II
Dihydroetorphine..........................            9334           II
Levo-alphacetylmethadol...................            9648           II
Oxymorphone...............................            9652           II
Noroxymorphone............................            9668           II
Phenazocine...............................            9715           II
Piminodine................................            9730           II
Racemethorphan............................            9732           II
Racemorphan...............................            9733           II
Alfentanil................................            9737           II
Remifentanil..............................            9739           II
Sufentanil................................            9740           II
Carfentanil...............................            9743           II
Tapentadol................................            9780           II
Bezitramide...............................            9800           II
Fentanyl..................................            9801           II
------------------------------------------------------------------------

    The company plans to import analytical reference standards for 
distribution to its customers for research and analytical purposes. 
Placement of these drug codes onto the company's registration does not 
translate into automatic approval of subsequent permit applications to 
import controlled substances. Approval of permit applications will 
occur only when the registrant's business activity is consistent with 
what is authorized under 21 U.S.C. 952(a)(2).
    Authorization will not extend to the import of FDA approved or non-
approved finished dosage forms for commercial sale.

    Dated: November 2, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25227 Filed 11-19-18; 8:45 am]
 BILLING CODE 4410-09-P