Importer of Controlled Substances Application: Myonex Inc., 17627-17628 [2023-05913]

Download as PDF 17627 Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices Controlled substance Drug code Phenazocine .......................................................................................................................................................................... Thiafentanil ............................................................................................................................................................................ Piminodine ............................................................................................................................................................................. Racemethorphan ................................................................................................................................................................... Racemorphan ........................................................................................................................................................................ Alfentanil ................................................................................................................................................................................ Remifentanil ........................................................................................................................................................................... Sufentanil ............................................................................................................................................................................... Carfentanil ............................................................................................................................................................................. Tapentadol ............................................................................................................................................................................. Bezitramide ............................................................................................................................................................................ Fentanyl ................................................................................................................................................................................. Moramide-intermediate .......................................................................................................................................................... The company plans to import analytical reference standards for distribution to its customers for research and analytics 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 in 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. [FR Doc. 2023–05916 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1169] Importer of Controlled Substances Application: Purisys, LLC Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Purisys, 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 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 19:23 Mar 22, 2023 Jkt 259001 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 February 15, 2023, Purisys, LLC, 1550 Olympic Drive, Athens, Georgia 30601–1602, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Marihuana Extract ........... Marihuana ........................ Tetrahydrocannabinols .... Nabilone .......................... Phenylacetone ................. Ecgonine .......................... Levorphanol ..................... Thebaine .......................... Opium, raw ...................... Opium, powdered ............ Opium, granulated ........... PO 00000 Frm 00112 Fmt 4703 Noroxymorphone ............. Poppy Straw Concentrate Tapentadol ...................... II II II II II II II II II II II II II Drug code Schedule 9668 9670 9780 II II II The company plans to import Opium, Raw (9600), Opium, Powered (9639) and Opium, Granulated (9640) to manufacture an Active Pharmaceutical Ingredient (API) only for distribution to its customers. The company plans to import Phenylacetone (8501) and Poppy Straw Concentrate (9670), to bulk manufacture other Controlled substances for distribution to its customers. The company plans to import impurities of buprenorphine that have been determined by DEA to be captured under Thebaine (9333). In reference to Marihuana Extract (7350), Marihuana (7360) and Tetrahydrocannabinols (7370) the company plans to import as synthetic. No other activity for these drug codes is 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. [FR Doc. 2023–05939 Filed 3–22–23; 8:45 am] BILLING CODE P Drug code Schedule 7350 7360 7370 7379 8501 9180 9220 9333 9600 9639 9640 I I I II II II II II II II II Sfmt 4703 Controlled substance 9715 9729 9730 9732 9733 9737 9739 9740 9743 9780 9800 9801 9802 Schedule DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1145] Importer of Controlled Substances Application: Myonex Inc. Drug Enforcement Administration, Justice. AGENCY: E:\FR\FM\23MRN1.SGM 23MRN1 17628 ACTION: Federal Register / Vol. 88, No. 56 / Thursday, March 23, 2023 / Notices Notice of application. Controlled substance Myonex Inc. 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. 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 21, 2022, Myonex Inc.. 100 Progress Drive, Horsham, Pennsylvania 19044, applied to be registered as an importer of the following basic class(es) of controlled substance(s): ddrumheller on DSK120RN23PROD with NOTICES1 DATES: Controlled substance Amphetamine .................. Lisdexamfetamine ........... Methylphenidate .............. Nabilone .......................... Oxycodone ...................... Hydromorphone ............... Hydrocodone ................... VerDate Sep<11>2014 Drug code Schedule 1100 1205 1724 7379 9143 9150 9193 II II II II II II II 19:23 Mar 22, 2023 Jkt 259001 Morphine .......................... Oxymorphone .................. Fentanyl ........................... Drug code Schedule 9300 9652 9801 II II II The company plans to import the listed controlled substances in dosage form for clinical trials, research, and analytical 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 nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–05913 Filed 3–22–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE 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 January 10, 2023, Scottsdale Research Institute, 5436 East Tapekim Road, Cave Creek, Arizona 85331, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): Controlled substance Psilocybin ....................... Psilocyn .......................... Drug code Schedule 7437 7438 I I The company plans to bulk manufacture the listed controlled substances for internal research and analytical development purposes. No other activities for these drug codes are authorized for this registration. Drug Enforcement Administration Matthew Strait, Deputy Assistant Administrator. [Docket No. DEA–1162] [FR Doc. 2023–05921 Filed 3–22–23; 8:45 am] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: Scottsdale Research Institute Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Drug Enforcement Administration [Docket No. DEA–1163] Scottsdale Research Institute, 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. 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 SUMMARY: PO 00000 Frm 00113 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Sigma Aldrich Research Biochemicals, 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. ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17627-17628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05913]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1145]


Importer of Controlled Substances Application: Myonex Inc.

AGENCY: Drug Enforcement Administration, Justice.

[[Page 17628]]


ACTION: Notice of application.

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

SUMMARY: Myonex Inc. 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 21, 2022, Myonex Inc.. 100 Progress Drive, 
Horsham, Pennsylvania 19044, applied to be registered as an importer of 
the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Amphetamine.............................    1100  II
Lisdexamfetamine........................    1205  II
Methylphenidate.........................    1724  II
Nabilone................................    7379  II
Oxycodone...............................    9143  II
Hydromorphone...........................    9150  II
Hydrocodone.............................    9193  II
Morphine................................    9300  II
Oxymorphone.............................    9652  II
Fentanyl................................    9801  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
dosage form for clinical trials, research, and analytical 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-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-05913 Filed 3-22-23; 8:45 am]
BILLING CODE P
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