Importer of Controlled Substances Application: Aurobindo Pharma USA, Inc., 50903 [2021-19631]

Download as PDF 50903 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices other activity under this registration aside from those coincident activities specifically authorized by DEA regulations. DEA will evaluate the application for registration as a bulk manufacturer for compliance with all applicable laws, treaties, and regulations and to ensure adequate safeguards against diversion are in place. As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. In accordance with 21 CFR 1301.33(a), DEA is providing notice that on July 1, 2021, Amethyst Exploration, LLC., 4210 Jewell Road, Sparta, Georgia 31087, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: Drug code Controlled substance Marihuana Extract ......... Marihuana ...................... Tetrahydrocannabinols .. I 7350 7360 7370 Schedule I I I I Brian S. Besser, Acting Assistant Administrator. [FR Doc. 2021–19629 Filed 9–10–21; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–899] lotter on DSK11XQN23PROD with NOTICES1 I I I II II II II II II II The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to isolate these controlled substances from procured 7350 (Marihuana Extract). In reference to drug code 7360, no cultivation activities are authorized for this registration. In reference to drug code 9333 (Thebaine), the company plans to manufacture a Thebaine derivative. No other activities for these drug codes are authorized for this registration. DEPARTMENT OF JUSTICE Drug Enforcement Administration Eli-Elsohly Laboratories 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 file written comments on or objections to the issuance of the proposed registration on or before November 12, 2021. Such persons may also file a written request for a hearing on the application on or before November 12, 2021. Jkt 253001 7350 7360 7370 1100 1105 9041 9050 9120 9180 9333 Schedule BILLING CODE P Drug Enforcement Administration, Justice. ACTION: Notice of application. 17:39 Sep 10, 2021 Marihuana Extract ......... Marihuana ...................... Tetrahydrocannabinols .. Amphetamine ................ Methamphetamine ......... Cocaine ......................... Codeine ......................... Dihydrocodeine .............. Ecgonine ........................ Thebaine ........................ Drug code [FR Doc. 2021–19679 Filed 9–10–21; 8:45 am] AGENCY: VerDate Sep<11>2014 Controlled substances Brian S. Bresser, Acting Assistant Administrator. Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories SUMMARY: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on August 5, 2021, EliElsohly Laboratories, 5 Industrial Park Drive, Oxford, Mississippi 38655, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s): ADDRESSES: [Docket No. DEA–897] Importer of Controlled Substances Application: Aurobindo Pharma USA, Inc. 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 October 13, 2021. Such persons may also file a written request for a hearing on the application on or before October 13, 2021. 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 a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests 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. ADDRESSES: In accordance with 21 CFR 1301.34(a), this is notice that on July 20, 2021, Aurobindo Pharma USA, Inc., 6 Wheeling Road, Dayton, New Jersey 08810–1526, applied to be registered as an importer of the following basic class(es) of controlled substance(s): SUPPLEMENTARY INFORMATION: Drug code Controlled substance Remifentanil ................... I 9739 Brian S. Besser, Acting Assistant Administrator. Aurobindo Pharma USA, 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. BILLING CODE P SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 9990 III The company plans to import Remifentanil (9739) in bulk form for research and development. No other activity for this drug code 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. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Schedule [FR Doc. 2021–19631 Filed 9–10–21; 8:45 am] E:\FR\FM\13SEN1.SGM 13SEN1

Agencies

[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Page 50903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19631]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-897]


Importer of Controlled Substances Application: Aurobindo Pharma 
USA, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Aurobindo Pharma USA, 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 file written comments on or objections to 
the issuance of the proposed registration on or before October 13, 
2021. Such persons may also file a written request for a hearing on the 
application on or before October 13, 2021.

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 
requests 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 July 20, 2021, Aurobindo Pharma USA, Inc., 6 Wheeling 
Road, Dayton, New Jersey 08810-1526, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Remifentanil...........................     9739  II
------------------------------------------------------------------------

The company plans to import Remifentanil (9739) in bulk form for 
research and development. No other activity for this drug code 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.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-19631 Filed 9-10-21; 8:45 am]
BILLING CODE P
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