Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company, 60900-60903 [2018-25865]

Download as PDF 60900 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for product development and distribution to its customers. No other activity for these drug codes are authorized for this registration. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018–25862 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Fisher Clinical Services, Inc. ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and DATES: applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. 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. In accordance with 21 CFR 1301.34(a), this is notice that on September 27, 2018, Fisher Clinical Services, Inc., 700A–C Nestle Way, Breinigsville, Pennsylvania 18031, has applied to be registered as an importer of the below listed basic classes of controlled substances listed in schedule I & II. Controlled substance Drug code Psilocybin ................................................................................................................................................................. Methylphenidate ....................................................................................................................................................... Levorphanol ............................................................................................................................................................. Noroxymorphone ..................................................................................................................................................... Tapentadol ............................................................................................................................................................... The company plans to import the listed controlled substances for analytical research, testing, and clinical trials. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. DEPARTMENT OF JUSTICE Dated: November 16, 2018. John J. Martin, Assistant Administrator. ACTION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company Notice of application. 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 January 28, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his DATES: [FR Doc. 2018–25872 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P amozie on DSK3GDR082PROD with NOTICES1 Drug Enforcement Administration Jkt 247001 PO 00000 Frm 00080 Fmt 4703 I II II II II Drug code 3-Fluoro-N-methylcathinone (3–FMC) ....................................................................................................................... Cathinone ................................................................................................................................................................... Methcathinone ............................................................................................................................................................ 4-Fluoro-N-methylcathinone (4–FMC) ....................................................................................................................... 17:45 Nov 26, 2018 7437 1724 9220 9668 9780 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. In accordance with 21 CFR 1301.33(a), this is notice that on July 25, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 Schedule Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 1233 1235 1237 1238 Schedule I I I I 60901 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 Controlled substance Drug code Pentedrone (a-methylaminovalerophenone) .............................................................................................................. Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................... 4-Methyl-N-ethylcathinone (4–MEC) .......................................................................................................................... Naphyrone .................................................................................................................................................................. N-Ethylamphetamine .................................................................................................................................................. N,N-Dimethylamphetamine ........................................................................................................................................ Fenethylline ................................................................................................................................................................ Aminorex .................................................................................................................................................................... 4-Methylaminorex (cis isomer) ................................................................................................................................... Gamma Hydroxybutyric Acid ..................................................................................................................................... Methaqualone ............................................................................................................................................................. Mecloqualone ............................................................................................................................................................. JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ............................................................................................ SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) .......................................... ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ....... 5-Fluoro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ........... AB–FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ................ JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) ................................................................................................................. MDMB–FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ................. 2-(1-(4-fluorobenzyl)-1Hinsazole-3-carboxamido)-3-methylbutanoate ....................................................................... AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................... THJ–2201 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone .............................................................. 5F–AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2yl)-1-(5-fluoropentyl)-1 H-indazole-3-carboxamide) ............... AB–CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide ........... MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) .. 5F–AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ......................................... 5F–ADB; 5F–MDMB–PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ........................... MDMB–CHMICA, MMB–CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3dimethylbutanoate). MMB–CHMICA, AMB–CHMICA (methyl 2-(1(cyclohexylmethyl)-1 H-indole-3-carboxamido)-3methylbutanoate) ... APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ......................................................... 5F–APINACA, 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ............................. JWH–081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) ............................................................................................ 5F–CUMYL–P7AICA (1-(5-fluoropentyl)-N-(2phenylpropan-2-yl)-1 H-pyrrolo[2,3-b]pyridine-3carboxamide) ........... 4–CN–CUMYL–BUTINACA (1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1 H-indazole-3-carboxamide) ..................... SR–19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole ............................................................... JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ........................................................................ JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) ............................................................................................... UR–144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ........................................................... JWH–073 (1-Butyl-3-(1-naphthoyl)indole) .................................................................................................................. JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ..................................................................................... AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ................................................................................................. JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) ................................................................................................ NM2201; CBL2201 (Naphthalen-1-yl 1-(5-fluoropentyl)1 H-indole-3-carboxylate) .................................................... PB–22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate) ........................................................................................... 5F–PB–22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate) ....................................................................... Alpha-ethyltryptamine ................................................................................................................................................. Ibogaine ...................................................................................................................................................................... CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol) ........................................................... CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol) ..................................... Lysergic acid diethylamide ......................................................................................................................................... 2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7) ......................................................................................... Marihuana .................................................................................................................................................................. Tetrahydrocannabinols ............................................................................................................................................... Mescaline ................................................................................................................................................................... 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C–T–2 ) ..................................................................................... 3,4,5-Trimethoxyamphetamine ................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine ........................................................................................................................ 4-Bromo-2,5-dimethoxyphenethylamine .................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine ........................................................................................................................ 2,5-Dimethoxyamphetamine ...................................................................................................................................... JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) ................................................................................................ 2,5-Dimethoxy-4-ethylamphetamine .......................................................................................................................... 3,4-Methylenedioxyamphetamine .............................................................................................................................. 5-Methoxy-3,4-methylenedioxyamphetamine ............................................................................................................ N-Hydroxy-3,4-methylenedioxyamphetamine ............................................................................................................ 3,4-Methylenedioxy-N-ethylamphetamine .................................................................................................................. 3,4-Methylenedioxymethamphetamine ...................................................................................................................... 4-Methoxyamphetamine ............................................................................................................................................. 5-Methoxy-N-N-dimethyltryptamine ............................................................................................................................ Alpha-methyltryptamine .............................................................................................................................................. Diethyltryptamine ........................................................................................................................................................ Dimethyltryptamine ..................................................................................................................................................... VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 Schedule 1246 1248 1249 1258 1475 1480 1503 1585 1590 2010 2565 2572 6250 7008 7010 7011 7012 7019 7020 7021 7023 7024 7025 7031 7032 7033 7034 7035 7042 I I I I I I I I I I I I I I I I I I I I I I I I I I I I I 7044 7048 7049 7081 7085 7089 7104 7118 7122 7144 7173 7200 7201 7203 7221 7222 7225 7249 7260 7297 7298 7315 7348 7360 7370 7381 7385 7390 7391 7392 7395 7396 7398 7399 7400 7401 7402 7404 7405 7411 7431 7432 7434 7435 I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I 60902 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices amozie on DSK3GDR082PROD with NOTICES1 Controlled substance Drug code Psilocybin ................................................................................................................................................................... Psilocyn ...................................................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine ........................................................................................................................ N-Ethyl-1-phenylcyclohexylamine .............................................................................................................................. 1-(1-Phenylcyclohexyl)pyrrolidine .............................................................................................................................. 1-[1-(2-Thienyl)cyclohexyl]piperidine .......................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ......................................................................................................................... N-Benzylpiperazine .................................................................................................................................................... 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D) ............................................................................................ 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E ) .............................................................................................. 2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) ........................................................................................................... 2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C–I) .................................................................................................. 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C–C) ............................................................................................. 2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C–N) ............................................................................................... 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C–P) ........................................................................................ 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4 ) ............................................................................. MDPV (3,4-Methylenedioxypyrovalerone) ................................................................................................................. 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B–NBOMe) ............................................... 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C–NBOMe) ............................................... 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe) ................................................... Methylone (3,4-Methylenedioxy-N-methylcathinone) ................................................................................................. Butylone ..................................................................................................................................................................... Pentylone ................................................................................................................................................................... alpha-pyrrolidinopentiophenone (a-PVP) ................................................................................................................... alpha-pyrrolidinobutiophenone (a-PBP) ..................................................................................................................... AM–694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) .............................................................................................. Acetyldihydrocodeine ................................................................................................................................................. Benzylmorphine .......................................................................................................................................................... Codeine-N-oxide ........................................................................................................................................................ Desomorphine ............................................................................................................................................................ Etorphine (except HCl) ............................................................................................................................................... Codeine methylbromide ............................................................................................................................................. Dihydromorphine ........................................................................................................................................................ Heroin ......................................................................................................................................................................... Morphine-N-oxide ....................................................................................................................................................... Normorphine ............................................................................................................................................................... U–47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) ......................................................... MT–45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)) ............................................................................................. Tilidine ........................................................................................................................................................................ Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) ........................................................................... Para-Fluorofentanyl .................................................................................................................................................... 3-Methylfentanyl ......................................................................................................................................................... Alpha-methylfentanyl .................................................................................................................................................. Acetyl-alpha-methylfentanyl ....................................................................................................................................... N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide .................................................................................. Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ......................................................................... Butyryl Fentanyl ......................................................................................................................................................... Para-fluorobutyryl fentanyl ......................................................................................................................................... 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ................................... 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide .................................................................................... Para-chloroisobutyryl fentanyl .................................................................................................................................... Isobutyryl fentanyl ...................................................................................................................................................... Beta-hydroxyfentanyl .................................................................................................................................................. Beta-hydroxy-3-methylfentanyl ................................................................................................................................... Alpha-methylthiofentanyl ............................................................................................................................................ 3-Methylthiofentanyl ................................................................................................................................................... Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) ........................................................ Thiofentanyl ................................................................................................................................................................ Beta-hydroxythiofentanyl ............................................................................................................................................ Para-methoxybutyryl fentanyl ..................................................................................................................................... Ocfentanil ................................................................................................................................................................... Valeryl fentanyl ........................................................................................................................................................... N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide ..................................................................... Cyclopropyl Fentanyl .................................................................................................................................................. Cyclopentyl fentanyl ................................................................................................................................................... Fentanyl related-compounds as defined in 21 CFR 1308.11&h) .............................................................................. Amphetamine ............................................................................................................................................................. Methamphetamine ...................................................................................................................................................... Lisdexamfetamine ...................................................................................................................................................... Phenmetrazine ........................................................................................................................................................... Methylphenidate ......................................................................................................................................................... Amobarbital ................................................................................................................................................................ Pentobarbital .............................................................................................................................................................. Secobarbital ............................................................................................................................................................... VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 7437 7438 7439 7455 7458 7470 7473 7493 7508 7509 7517 7518 7519 7521 7524 7532 7535 7536 7537 7538 7540 7541 7542 7545 7546 7694 9051 9052 9053 9055 9056 9070 9145 9200 9307 9313 9547 9560 9750 9811 9812 9813 9814 9815 9816 9821 9822 9823 9824 9825 9826 9827 9830 9831 9832 9833 9834 9835 9836 9837 9838 9840 9843 9845 9847 9850 1100 1105 1205 1631 1724 2125 2270 2315 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II 60903 Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices Controlled substance Drug code Phencyclidine ............................................................................................................................................................. 4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................... Phenylacetone ............................................................................................................................................................ 1-Piperidinocyclohexanecarbonitrile ........................................................................................................................... Cocaine ...................................................................................................................................................................... Codeine ...................................................................................................................................................................... Etorphine HCl ............................................................................................................................................................. Dihydrocodeine .......................................................................................................................................................... Oxycodone ................................................................................................................................................................. Hydromorphone .......................................................................................................................................................... Ecgonine .................................................................................................................................................................... Ethylmorphine ............................................................................................................................................................ Hydrocodone .............................................................................................................................................................. Levomethorphan ........................................................................................................................................................ Levorphanol ................................................................................................................................................................ Isomethadone ............................................................................................................................................................. Meperidine .................................................................................................................................................................. Meperidine intermediate-B ......................................................................................................................................... Methadone ................................................................................................................................................................. Dextropropoxyphene, bulk (non-dosage forms) ........................................................................................................ Morphine .................................................................................................................................................................... Thebaine .................................................................................................................................................................... Oxymorphone ............................................................................................................................................................. Thiafentanil ................................................................................................................................................................. Alfentanil ..................................................................................................................................................................... Remifentanil ............................................................................................................................................................... Sufentanil ................................................................................................................................................................... Carfentanil .................................................................................................................................................................. Tapentadol ................................................................................................................................................................. Fentanyl ...................................................................................................................................................................... The company plans to bulk manufacture the listed controlled substances to produce forensic and research analytical reference standards for distribution to its customers. issuance of the proposed registration on or before December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. Dated: November 16, 2018. John J. Martin, Assistant Administrator. ADDRESSES: [FR Doc. 2018–25865 Filed 11–26–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Importer of Controlled Substances Application: Sigma Aldrich Co., LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the DATES: 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. The Attorney General has delegated his SUPPLEMENTARY INFORMATION: amozie on DSK3GDR082PROD with NOTICES1 Jkt 247001 PO 00000 Frm 00083 Fmt 4703 II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II Drug code Cathinone ................................................................................................................................................................ Methcathinone ......................................................................................................................................................... Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................ Aminorex ................................................................................................................................................................. Gamma Hydroxybutyric Acid ................................................................................................................................... Methaqualone .......................................................................................................................................................... Alpha-ethyltryptamine .............................................................................................................................................. Ibogaine ................................................................................................................................................................... Lysergic acid diethylamide ...................................................................................................................................... 17:45 Nov 26, 2018 7471 8333 8501 8603 9041 9050 9059 9120 9143 9150 9180 9190 9193 9210 9220 9226 9230 9233 9250 9273 9300 9333 9652 9729 9737 9739 9740 9743 9780 9801 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. In accordance with 21 CFR 1301.34(a), this is notice that on February 21, 2018, Sigma Aldrich Co., LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance VerDate Sep<11>2014 Schedule Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1 1235 1237 1248 1585 2010 2565 7249 7260 7315 Schedule I I I I I I I I I

Agencies

[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60900-60903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25865]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cayman 
Chemical Company

ACTION: Notice of application.

-----------------------------------------------------------------------

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 January 28, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

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.
    In accordance with 21 CFR 1301.33(a), this is notice that on July 
25, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, 
Michigan 48108 applied to be registered as a bulk manufacturer for the 
basic classes of controlled substances:

------------------------------------------------------------------------
       Controlled substance           Drug code           Schedule
------------------------------------------------------------------------
3-Fluoro-N-methylcathinone (3-               1233  I
 FMC).
Cathinone........................            1235  I
Methcathinone....................            1237  I
4-Fluoro-N-methylcathinone (4-               1238  I
 FMC).

[[Page 60901]]

 
Pentedrone ([alpha]-                         1246  I
 methylaminovalerophenone).
Mephedrone (4-Methyl-N-                      1248  I
 methylcathinone).
4-Methyl-N-ethylcathinone (4-MEC)            1249  I
Naphyrone........................            1258  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).
ADB-FUBINACA (N-(1-amino-3,3-                7010  I
 dimethyl-1-oxobutan-2-yl)-1-(4-
 fluorobenzyl)-1H-indazole-3-
 carboxamide).
5-Fluoro-UR-144 and XLR11 [1-(5-             7011  I
 Fluoro-pentyl)1H-indol-3-
 yl](2,2,3,3-
 tetramethylcyclopropyl)methanone.
AB-FUBINACA (N-(1-amino-3-methyl-            7012  I
 1-oxobutan-2-yl)-1-(4-
 fluorobenzyl)-1H-indazole-3-
 carboxamide).
JWH-019 (1-Hexyl-3-(1-                       7019  I
 naphthoyl)indole).
MDMB-FUBINACA (Methyl 2-(1-(4-               7020  I
 fluorobenzyl)-1H-indazole-3-
 carboxamido)-3,3-
 dimethylbutanoate).
2-(1-(4-fluorobenzyl)-1Hinsazole-            7021  I
 3-carboxamido)-3-methylbutanoate.
AB-PINACA (N-(1-amino-3-methyl-1-            7023  I
 oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide).
THJ-2201 [1-(5-fluoropentyl)-1H-             7024  I
 indazol-3-yl](naphthalen-1-
 yl)methanone.
5F-AB-PINACA (N-(1-amino-3-methyl-           7025  I
 1-oxobutan-2yl)-1-(5-
 fluoropentyl)-1 H-indazole-3-
 carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-            7031  I
 1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide.
MAB-CHMINACA (N-(1-amino-                    7032  I
 3,3dimethyl-1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
5F-AMB (Methyl 2-(1-(5-                      7033  I
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-            7034  I
 (1-(5-fluoropentyl)-1H-indazole-
 3-carboxamido)-3,3-
 dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-                  7035  I
 dimethyl-1-oxobutan-2-yl)-1-
 pentyl-1H-indazole-3-
 carboxamide).
MDMB-CHMICA, MMB-CHMINACA (Methyl            7042  I
 2-(1-(cyclohexylmethyl)-1H-
 indole-3-carboxamido)-3,3-
 dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-            7044  I
 (1(cyclohexylmethyl)-1 H-indole-
 3-carboxamido)-3methylbutanoate).
APINACA and AKB48 N-(1-Adamantyl)-           7048  I
 1-pentyl-1H-indazole-3-
 carboxamide.
5F-APINACA, 5F-AKB48 (N-                     7049  I
 (adamantan-1-yl)-1-(5-
 fluoropentyl)-1H-indazole-3-
 carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-                   7081  I
 methoxynaphthoyl) indole).
5F-CUMYL-P7AICA (1-(5-                       7085  I
 fluoropentyl)-N-(2phenylpropan-2-
 yl)-1 H-pyrrolo[2,3-b]pyridine-
 3carboxamide).
4-CN-CUMYL-BUTINACA (1-(4-                   7089  I
 cyanobutyl)-N-(2phenylpropan-2-
 yl)-1 H-indazole-3-carboxamide).
SR-19 (Also known as RCS-4) (1-              7104  I
 Pentyl-3-[(4-methoxy)-benzoyl]
 indole.
JWH-018 (also known as AM678) (1-            7118  I
 Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-             7122  I
 naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3-                 7144  I
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone.
JWH-073 (1-Butyl-3-(1-                       7173  I
 naphthoyl)indole).
JWH-200 (1-[2-(4-                            7200  I
 Morpholinyl)ethyl]-3-(1-
 naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-             7201  I
 naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2-                      7203  I
 chlorophenylacetyl) indole).
NM2201; CBL2201 (Naphthalen-1-yl             7221  I
 1-(5-fluoropentyl)1 H-indole-3-
 carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H-            7222  I
 indole-3-carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-                7225  I
 fluoropentyl)-1H-indole-3-
 carboxylate).
Alpha-ethyltryptamine............            7249  I
Ibogaine.........................            7260  I
CP-47,497 (5-(1,1-Dimethylheptyl)-           7297  I
 2-[(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
Mescaline........................            7381  I
2-(4-Ethylthio-2,5-                          7385  I
 dimethoxyphenyl) ethanamine (2C-
 T-2 ).
3,4,5-Trimethoxyamphetamine......            7390  I
4-Bromo-2,5-dimethoxyamphetamine.            7391  I
4-Bromo-2,5-                                 7392  I
 dimethoxyphenethylamine.
4-Methyl-2,5-dimethoxyamphetamine            7395  I
2,5-Dimethoxyamphetamine.........            7396  I
JWH-398 (1-Pentyl-3-(4-chloro-1-             7398  I
 naphthoyl) indole).
2,5-Dimethoxy-4-ethylamphetamine.            7399  I
3,4-Methylenedioxyamphetamine....            7400  I
5-Methoxy-3,4-                               7401  I
 methylenedioxyamphetamine.
N-Hydroxy-3,4-                               7402  I
 methylenedioxyamphetamine.
3,4-Methylenedioxy-N-                        7404  I
 ethylamphetamine.
3,4-Methylenedioxymethamphetamine            7405  I
4-Methoxyamphetamine.............            7411  I
5-Methoxy-N-N-dimethyltryptamine.            7431  I
Alpha-methyltryptamine...........            7432  I
Diethyltryptamine................            7434  I
Dimethyltryptamine...............            7435  I

[[Page 60902]]

 
Psilocybin.......................            7437  I
Psilocyn.........................            7438  I
5-Methoxy-N,N-                               7439  I
 diisopropyltryptamine.
N-Ethyl-1-phenylcyclohexylamine..            7455  I
1-(1-Phenylcyclohexyl)pyrrolidine            7458  I
1-[1-(2-                                     7470  I
 Thienyl)cyclohexyl]piperidine.
1-[1-(2-                                     7473  I
 Thienyl)cyclohexyl]pyrrolidine.
N-Benzylpiperazine...............            7493  I
2-(2,5-Dimethoxy-4-methylphenyl)             7508  I
 ethanamine (2C-D).
2-(2,5-Dimethoxy-4-ethylphenyl)              7509  I
 ethanamine (2C-E ).
2-(2,5-Dimethoxyphenyl)                      7517  I
 ethanamine (2C-H).
2-(4-iodo-2,5-dimethoxyphenyl)               7518  I
 ethanamine (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)-                      7524  I
 propylphenyl) ethanamine (2C-P).
2-(4-Isopropylthio)-2,5-                     7532  I
 dimethoxyphenyl) ethanamine (2C-
 T-4 ).
MDPV (3,4-                                   7535  I
 Methylenedioxypyrovalerone).
2-(4-bromo-2,5-dimethoxyphenyl)-N-           7536  I
 (2-methoxybenzyl) ethanamine
 (25B-NBOMe).
2-(4-chloro-2,5-dimethoxyphenyl)-            7537  I
 N-(2-methoxybenzyl) ethanamine
 (25C-NBOMe).
2-(4-iodo-2,5-dimethoxyphenyl)-N-            7538  I
 (2-methoxybenzyl) ethanamine
 (25I-NBOMe).
Methylone (3,4-Methylenedioxy-N-             7540  I
 methylcathinone).
Butylone.........................            7541  I
Pentylone........................            7542  I
alpha-pyrrolidinopentiophenone               7545  I
 ([alpha]-PVP).
alpha-pyrrolidinobutiophenone                7546  I
 ([alpha]-PBP).
AM-694 (1-(5-Fluoropentyl)-3-(2-             7694  I
 iodobenzoyl) indole).
Acetyldihydrocodeine.............            9051  I
Benzylmorphine...................            9052  I
Codeine-N-oxide..................            9053  I
Desomorphine.....................            9055  I
Etorphine (except HCl)...........            9056  I
Codeine methylbromide............            9070  I
Dihydromorphine..................            9145  I
Heroin...........................            9200  I
Morphine-N-oxide.................            9307  I
Normorphine......................            9313  I
U-47700 (3,4-dichloro-N-[2-                  9547  I
 (dimethylamino)cyclohexyl]-N-
 methylbenzamide).
MT-45 (1-cyclohexyl-4-(1,2-                  9560  I
 diphenylethyl)piperazine)).
Tilidine.........................            9750  I
Acryl fentanyl (N-(1-                        9811  I
 phenethylpiperidin-4-yl)-N-
 phenylacrylamide).
Para-Fluorofentanyl..............            9812  I
3-Methylfentanyl.................            9813  I
Alpha-methylfentanyl.............            9814  I
Acetyl-alpha-methylfentanyl......            9815  I
N-(2-fluorophenyl)-N-(1-                     9816  I
 phenethylpiperidin-4-
 yl)propionamide.
Acetyl Fentanyl (N-(1-                       9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl.................            9822  I
Para-fluorobutyryl fentanyl......            9823  I
4-Fluoroisobutyryl fentanyl (N-(4-           9824  I
 fluorophenyl)-N-(1-
 phenethylpiperidin-4-
 yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-           9825  I
 4-yl)-N-phenylacetamide.
Para-chloroisobutyryl fentanyl...            9826  I
Isobutyryl fentanyl..............            9827  I
Beta-hydroxyfentanyl.............            9830  I
Beta-hydroxy-3-methylfentanyl....            9831  I
Alpha-methylthiofentanyl.........            9832  I
3-Methylthiofentanyl.............            9833  I
Furanyl fentanyl (N-(1-                      9834  I
 phenethylpiperidin-4-yl)-N-
 phenylfuran-2-carboxamide).
Thiofentanyl.....................            9835  I
Beta-hydroxythiofentanyl.........            9836  I
Para-methoxybutyryl fentanyl.....            9837  I
Ocfentanil.......................            9838  I
Valeryl fentanyl.................            9840  I
N-(1-phenethylpiperidin-4-yl)-N-             9843  I
 phenyltetrahydrofuran-2-
 carboxamide.
Cyclopropyl Fentanyl.............            9845  I
Cyclopentyl fentanyl.............            9847  I
Fentanyl related-compounds as                9850  I
 defined in 21 CFR 1308.11&h).
Amphetamine......................            1100  II
Methamphetamine..................            1105  II
Lisdexamfetamine.................            1205  II
Phenmetrazine....................            1631  II
Methylphenidate..................            1724  II
Amobarbital......................            2125  II
Pentobarbital....................            2270  II
Secobarbital.....................            2315  II

[[Page 60903]]

 
Phencyclidine....................            7471  II
4-Anilino-N-phenethyl-4-                     8333  II
 piperidine (ANPP).
Phenylacetone....................            8501  II
1-                                           8603  II
 Piperidinocyclohexanecarbonitril
 e.
Cocaine..........................            9041  II
Codeine..........................            9050  II
Etorphine HCl....................            9059  II
Dihydrocodeine...................            9120  II
Oxycodone........................            9143  II
Hydromorphone....................            9150  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
Methadone........................            9250  II
Dextropropoxyphene, bulk (non-               9273  II
 dosage forms).
Morphine.........................            9300  II
Thebaine.........................            9333  II
Oxymorphone......................            9652  II
Thiafentanil.....................            9729  II
Alfentanil.......................            9737  II
Remifentanil.....................            9739  II
Sufentanil.......................            9740  II
Carfentanil......................            9743  II
Tapentadol.......................            9780  II
Fentanyl.........................            9801  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances to produce forensic and research analytical reference 
standards for distribution to its customers.

    Dated: November 16, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-25865 Filed 11-26-18; 8:45 am]
 BILLING CODE 4410-09-P