Importer of Controlled Substances Application: Myonex Inc., 10388 [2022-03903]

Download as PDF 10388 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on December 15, 2021, Mylan Inc., 3711 Collins Ferry Road, Morgantown, West Virginia 26505– 2362, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Amphetamine .................. Methylphenidate .............. Oxycodone ...................... Hydromorphone ............... Methadone ...................... Morphine .......................... Fentanyl ........................... Drug code Schedule 1100 1724 9143 9150 9250 9300 9801 II II II II II II II The company plans to import finished dosage forms for analytical testing and distribution for clinical trials. 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 the Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew J. Strait, Deputy Assistant Administrator. listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before March 28, 2022. Such persons may also file a written request for a hearing on the application on or before March 28, 2022. 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 a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for a 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: In accordance with 21 CFR 1301.34(a), this is notice that on December 10, 2021, 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): [FR Doc. 2022–03907 Filed 2–23–22; 8:45 am] Controlled substance BILLING CODE P Amphetamine .................. Lisdexamfetamine ........... Methylphenidate .............. Nabilone .......................... Oxycodone ...................... Hydromorphone ............... Hydrocodone ................... Morphine .......................... Oxymorphone .................. Fentanyl ........................... DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–960] Importer of Controlled Substances Application: Myonex Inc. Drug code Schedule 1100 1205 1724 7379 9143 9150 9193 9300 9652 9801 II II II II II II II II II II Matthew J. Strait, Deputy Assistant Administrator. [FR Doc. 2022–03903 Filed 2–23–22; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–953] Bulk Manufacturer of Controlled Substances Application: Benuvia Therapeutics Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Benuvia Therapeutics Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information. DATES: Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before April 25, 2022. Such persons may also file a written request for a hearing on the application on or before April 25, 2022. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUMMARY: In accordance with 21 CFR 1301.33(a), this is notice that on November 16, 2021, Benuvia Therapeutics Inc., 2700 Oakmont Drive, Round Rock, Texas 78665, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Myonex Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTAL INFORMATION SUMMARY: 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. The company plans to import the listed controlled substances for clinical trials, research, and analytical purposes. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant’s jspears on DSK121TN23PROD with NOTICES1 Controlled substance Drug code Tetrahydrocannabinols .................................................................................................................................................... 3,4-Methylenedioxyamphetamine .................................................................................................................................... 3,4-Methylenedioxymethamphetamine ............................................................................................................................ 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................. Dimethyltryptamine .......................................................................................................................................................... Psilocybin ......................................................................................................................................................................... Psilocyn ........................................................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................. VerDate Sep<11>2014 16:46 Feb 23, 2022 Jkt 256001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\24FEN1.SGM 24FEN1 7370 7400 7405 7431 7435 7437 7438 7439 Schedule I I I I I I I I

Agencies

[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Page 10388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03903]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-960]


Importer of Controlled Substances Application: Myonex Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Myonex Inc. has applied to be registered as an importer of 
basic class(es) of controlled substance(s). Refer to Supplemental 
Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before March 28, 2022. 
Such persons may also file a written request for a hearing on the 
application on or before March 28, 2022.

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 a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for a 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: In accordance with 21 CFR 1301.34(a), this 
is notice that on December 10, 2021, 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 for 
clinical trials, research, and analytical purposes. 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 non-approved finished 
dosage forms for commercial sale.

Matthew J. Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-03903 Filed 2-23-22; 8:45 am]
BILLING CODE 4410-09-P
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