Federal Register - September 13, 2021
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Source: Federal Register
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. 823a. 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
1301.33a, 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 classes of controlled substances:
Drug code
Controlled substance Marihuana Extract
Marihuana
Tetrahydrocannabinols ..
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7350
7360
7370
Schedule
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I
Brian S. Besser, Acting Assistant Administrator.
FR Doc. 202119629 Filed 91021; 8:45 am BILLING CODE 441009P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Docket No. DEA899
lotter on DSK11XQN23PROD with NOTICES1
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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 classes of controlled substances. Refer to Supplementary Information listed below for further drug information.
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 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. 202119679 Filed 91021; 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 1301.33a, 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 classes of controlled substances:
ADDRESSES:
Docket No. DEA897
Importer of Controlled Substances Application: Aurobindo Pharma USA, Inc.
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 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 1301.34a, this is notice that on July 20, 2021, Aurobindo Pharma USA, Inc., 6
Wheeling Road, Dayton, New Jersey 088101526, applied to be registered as an importer of the following basic classes of controlled substances:
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 classes of controlled substances. Refer to Supplementary Information listed below for further drug information.
BILLING CODE P
SUMMARY:
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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 registrants business activity is consistent with what is authorized under 21 U.S.C. 952a2.
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. 202119631 Filed 91021; 8:45 am
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