DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 1386]
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of
Marihuana: Lily’s Eden Garden Farms Corporation
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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 [INSERT 60 DAYS AFTER PUBLICATION IN THE FEDERAL
REGISTER].
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), the Drug Enforcement Administration (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 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 May 6, 2024,
Lily’s Eden Garden Farms Corporation, 1821 Waterman Road, Delhi, New York 13753,
applied to be registered as a bulk manufacturer of the following basic class(es) of controlled
substances:

Controlled Substance

Drug Code

Schedule

Marihuana Extract
Marihuana

7350
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-13216 Filed: 6/14/2024 8:45 am; Publication Date: 6/17/2024]

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