Importer of Controlled Substances Application: Meridian Medical Technologies, LLC, 17622-17623 [2023-05911]

Download as PDF 17622 Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on February 8, 2023, Caliqor Coghlan Pharma Services, 1500 Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Lysergic Acid Diethylamide. 5-Methoxy-N, Ndimethyltryptamine. Tapentadol ...................... Drug code Schedule 7315 I 7431 I 9780 II The company plans to import the listed controlled substances as finished dosage units for use in clinical trials. No other activities for these drug codes are authorized for this registration. 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 Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on February 1, 2023, Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, Ohio 45237, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): ADDRESSES: Controlled substance Gamma-hydroxybutyric acid. Drug code Schedule 2010 I Drug Enforcement Administration The company plans to manufacture the above-listed controlled substance as Active Pharmaceutical Ingredient (API) that will be further synthesized into Food and Drug Administrationapproved dosage forms. No other activities for this drug code are authorized for this registration. [Docket No. DEA–1166] Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05938 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE [FR Doc. 2023–05944 Filed 3–22–23; 8:45 am] Bulk Manufacturer of Controlled Substances Application: Patheon Pharmaceuticals Inc. BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 24, 2023. Such persons may also file a written request for a hearing on the application on or before April 24, 2023. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on December 28, 2022, Meridian Medical Technologies, LLC, 2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DATES: Drug Enforcement Administration Controlled substance [Docket No. DEA–1154] Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before May 22, 2023. Such persons may also file a written request for a hearing on the application on or before May 22, 2023. ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:23 Mar 22, 2023 Jkt 259001 Importer of Controlled Substances Application: Meridian Medical Technologies, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Meridian Medical Technologies, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. SUMMARY: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 Morphine ......................... Drug code Schedule 9300 II The company plans to import the controlled substance for analytical and research purposes. No other activities for these drug codes are authorized for this registration. 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 Food and Drug Administration-approved or non- E:\FR\FM\23MRN1.SGM 23MRN1 17623 Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices approved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05911 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1159] Importer of Controlled Substances Application: Lipomed Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Lipomed has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information. SUMMARY: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before April 24, 2023. Such persons may also file a written request for a hearing on the application on or before April 24, 2023. DATES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If ADDRESSES: you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. All requests for a hearing must 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. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.34(a), this is notice that on February 9, 2023 Lipomed, 150 Cambridepark Drive, Suite 705, Cambridge, Massachusetts 02140–2300, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 Controlled substance Drug code 3-Fluoro-N-methylcathinone (3–FMC) ................................................................................................................................... Cathinone .............................................................................................................................................................................. Methcathinone ....................................................................................................................................................................... 4-Fluoro-N-methylcathinone (4–FMC) ................................................................................................................................... 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) ............................ FUB–AMB, MMB–FUBINACA, AMB–FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-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-3methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-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) ....................................... Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido) 3,3-dimethylbutanoate) ................................................................. MDMB–CHMICA, MMB–CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) MMB–CHMICA, AMB–CHMICA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate) .............. N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboximide) .................................................................................... 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) ........................................................................................................ 1-(5-Fluoropentyl)-1H-indazole-3-carboxamide ..................................................................................................................... 5F–CUMYL–P7AICA (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide) ..................... 4–CN–CUMYL–BUTINACA, 4-cyano-CUMYL–BUTINACA, 4–CN–CUMYL BINACA, CUMYL–4CN–BINACA, SGT–78 (1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide). 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) .................................................................................... VerDate Sep<11>2014 19:23 Mar 22, 2023 Jkt 259001 PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 E:\FR\FM\23MRN1.SGM 23MRN1 Schedule 1233 1235 1237 1238 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 7036 7042 7044 7047 7048 7049 7081 7083 7085 7089 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 7104 7118 I I

Agencies

[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17622-17623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05911]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1154]


Importer of Controlled Substances Application: Meridian Medical 
Technologies, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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

SUMMARY: Meridian Medical Technologies, LLC has applied to be 
registered as an importer of basic class(es) of controlled 
substance(s). Refer to Supplementary Information listed below for 
further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may submit electronic comments on or 
objections to the issuance of the proposed registration on or before 
April 24, 2023. Such persons may also file a written request for a 
hearing on the application on or before April 24, 2023.

ADDRESSES: The Drug Enforcement Administration requires that all 
comments be submitted electronically through the Federal eRulemaking 
Portal, which provides the ability to type short comments directly into 
the comment field on the web page or attach a file for lengthier 
comments. Please go to https://www.regulations.gov and follow the 
online instructions at that site for submitting comments. Upon 
submission of your comment, you will receive a Comment Tracking Number. 
Please be aware that submitted comments are not instantaneously 
available for public view on https://www.regulations.gov. If you have 
received a Comment Tracking Number, your comment has been successfully 
submitted and there is no need to resubmit the same comment. All 
requests for a hearing must 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. All requests for a hearing should also be 
sent to: Drug Enforcement Administration, Attn: Administrator, 8701 
Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 28, 2022, Meridian Medical Technologies, 
LLC, 2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Morphine...............................    9300  II
------------------------------------------------------------------------

    The company plans to import the controlled substance for analytical 
and research purposes. No other activities for these drug codes are 
authorized for this registration.
    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 Food and Drug Administration-approved or non-

[[Page 17623]]

approved finished dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-05911 Filed 3-22-23; 8:45 am]
BILLING CODE P
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