Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Amethyst Exploration, LLC
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Issuing agencies
Abstract
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Full Text
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<title>Federal Register, Volume 86 Issue 174 (Monday, September 13, 2021)</title>
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[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50902-50903]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19629]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-892]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Amethyst Exploration, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: The Drug Enforcement Administration (DEA) is providing notice
of an application it has received from an entity applying to be
registered to manufacture in bulk basic class(es) of controlled
substances listed in schedule I. DEA intends to evaluate this and other
pending applications according to its regulations governing the program
of growing marihuana for scientific and medical research under DEA
registration.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefor, may file written comments on or objections to
the issuance of the proposed registration on or before November 12,
2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW 8701
Morrissette Drive, Springfield, Virginia 22152. To ensure proper
handling of comments, please reference Docket No--DEA-XXX in all
correspondence, including attachments.
SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA)
prohibits the cultivation and distribution of marihuana except by
persons who are registered under the CSA to do so for lawful purposes.
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is
providing notice that the entity identified below has applied for
registration as a bulk manufacturer of schedule I controlled
substances. In response, registered bulk manufacturers of the affected
basic class(es), and applicants therefor, may file written comments on
or objections of the requested registration, as provided in this
notice. This notice does not constitute any evaluation or determination
of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical
ingredients (APIs) for product development and distribution to DEA
registered researchers. If the application for registration is granted,
the registrant would not be authorized to conduct
[[Page 50903]]
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:
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Drug
Controlled substance code Schedule
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Marihuana Extract...................... 7350 I
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
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Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-19629 Filed 9-10-21; 8:45 am]
BILLING CODE 4410-09-P
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