Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories
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 f...
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 23, 2026. Such persons may also file a written request for a hearing on the application on or before November 23, 2026.
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
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
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 5, 2026, 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 bulk 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.
www.regulations.gov
21 CFR 1301.33(a)