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Code · REGISTER · 2023-09-29 · Drug Enforcement Administration, Justice · Notices

Notices. Notice of application

391 words·~2 min read·/register/2023/09/29/2023-21400·

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BILLING CODE 4340-98-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-1270] 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 28, 2023.
Such persons may also file a written request for a hearing on the application on or before November 28, 2023. 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 24, 2023, 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 Amphetamine 1100 II Methamphetamine 1105 II Cocaine 9041 II Ecgonine 9180 II Codeine 9050 II Dihydrocodeine 9120 II Oxycodone 9143 II Dihydromorphine 9145 II Thebaine 9333 II The company plans to manufacture the listed controlled substances for product development and 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. Claude Redd, Acting Deputy Assistant Administrator. [FR Doc. 2023-21400 Filed 9-28-23; 8:45 am]
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