Federal Register / Vol. 90, No. 29 / Thursday, February 13, 2025 / Notices 9555 

Controlled substance Drug 

code Schedule 

Marihuana Extract ........... 7350 I 

Marihuana ........................ 7360 I 

Tetrahydrocannabinols .... 7370 I 

Nabilone .......................... 7379 II 

Phenylacetone ................. 8501 II 

Ecgonine .......................... 9180 II 

Levorphanol ..................... 9220 II 

Methadone ...................... 9250 II 

Thebaine .......................... 9333 II 

Opium, raw ...................... 9600 II 

Opium, powdered ............ 9639 II 

Opium, granulated ........... 9640 II 

Noroxymorphone ............. 9668 II 

Poppy Straw Concentrate 9670 II 

Tapentadol ...................... 9780 II 

The company plans to import Opium, 

Raw (9600), Opium, Powdered (9639) 

and Opium, Granulated (9640) to 

manufacture an Active Pharmaceutical 

Ingredient (API) only for distribution to 

its customers. The company plans to 

import Phenylacetone (8501) and Poppy 

Straw Concentrate (9670), to bulk 

manufacture other controlled substances 

for distribution to its customers. The 

company plans to import impurities of 

buprenorphine that have been 

determined by DEA to be captured 

under Thebaine (9333). In reference to 

Marihuana Extract (7350), Marihuana 

(7360), and Tetrahydrocannabinols 

(7370), the company plans to import as 

synthetic. The company plans to import 

an isomer of methadone (9250) not 

currently available domestically to 

manufacture a non-controlled 

substance. No other activities for these 

drug codes are authorized for this 

registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2025–02600 Filed 2–12–25; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 1447] 

Bulk Manufacturer of Controlled 

Substances Application: Bulk 

Manufacturer of Marihuana: University 

of Kentucky Cannabis Center 

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 April 14, 2025. 

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 July 1, 2024, University of Kentucky 

Cannabis Center, 845 Angliana Avenue, 

Lexington, Kentucky 40508, applied to 

be registered as a bulk manufacturer of 

the following basic class(es) of 

controlled substances: 

Controlled substance Drug 

code Schedule 

Marihuana ........................ 7360 I 

Matthew Strait, 

Deputy Assistant Administrator. 

[FR Doc. 2025–02595 Filed 2–12–25; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1487] 

Bulk Manufacturer of Controlled 

Substances Application: Maridose LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Maridose LLC has applied to 

be registered as a bulk manufacturer of 

basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

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 April 14, 2025. Such 

persons may also file a written request 

for a hearing on the application on or 

before April 14, 2025. 


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