Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: New Mexico Top Organics-Ultra Health
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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.
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<title>Federal Register, Volume 86 Issue 192 (Thursday, October 7, 2021)</title>
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[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55860-55861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21879]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-907]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: New Mexico Top Organics-Ultra Health
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 December 6,
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-907 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 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
[[Page 55861]]
reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on August 27, 2021, New Mexico Top Organics-Ultra Health, 225 Camino
Don Tomas, Bernalillo, New Mexico 87004, 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
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Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-21879 Filed 10-6-21; 8:45 am]
BILLING CODE P
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