[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Notices]
[Pages 37246-37247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09789]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1354]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Entheogen Pharmaceuticals Inc
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 therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
July 5, 2024.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.''
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 submit electronic
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
[[Page 37247]]
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 December 11, 2023, Entheogen Pharmaceuticals Inc, 17349 Muskrat
Avenue, Adelanto, California, 92301 applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
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Controlled substance Drug code Schedule
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Ibogaine........................... 7260 I
Lysergic Acid Diethylamide......... 7315 I
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Mescaline.......................... 7381 I
Dimethyltryptamine................. 7435 I
Psilocybin......................... 7437 I
Psilocyn........................... 7438 I
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In reference to drug codes 7260 (Ibogaine), 7315 (Lysergic Acid
Diethylamide), 7381 (Mescaline), 7435 (Dimethyltryptamine), 7437
(Psilocybin), and 7438 (Psilocyn), the company plans to bulk
manufacture the listed controlled substances for internal research and
analytical development purposes. No other activities for these drug
codes are authorized for this registration.
Marsha Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-09789 Filed 5-3-24; 8:45 am]
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