The eRulemaking Program

09/17/2024 | Press release | Distributed by Public on 09/17/2024 09:23

Bulk Manufacturer Eli Elsohly(2024 21060)DEA1432

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1432]

Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories

Agency

Drug Enforcement Administration, Justice.

Action

Notice of application.

Summary

Eli-Elsohly Laboratories 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 November 18, 2024. Such persons may also file a written request for a hearing on the application on or before November 18, 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

In accordance with 21 CFR 1301.33(a), this is notice that on August 16, 2024, Eli-Elsohly Laboratories, 5 Industrial Park Drive, Oxford, Mississippi 38655-5343, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
Marihuana Extract 7350 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Dihydromorphine 9145 I
Amphetamine 1100 II
Methamphetamine 1105 II
Cocaine 9041 II
Codeine 9050 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Ecgonine 9180 II
Thebaine 9333 II

The company plans to manufacture the listed controlled substances for product development reference standards. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to isolate these controlled substances from procured 7350 (Marihuana Extract). In reference to drug code 7360, no cultivation activities are authorized for this registration.

In reference to drug code 9333 (Thebaine), the company plans to manufacture a Thebaine derivative. No other activities for these drug codes are authorized for this registration.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-21060 Filed 9-16-24; 8:45 am]
BILLING CODE P