The eRulemaking Program

04/09/2024 | Press release | Distributed by Public on 04/09/2024 20:29

Bulk Manufacturer Biopharmaceutical(2024 19783)DEA1418

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1418]

Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company

Agency

Drug Enforcement Administration, Justice.

Action

Notice of application.

Summary

Biopharmaceutical Research Company 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 4, 2024. Such persons may also file a written request for a hearing on the application on or before November 4, 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 July 17, 2024, Biopharmaceutical Research Company, 11045 Commercial Parkway, Castroville, California 95012-3209, 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

The company plans to bulk manufacture the listed controlled substances to provided Pharmaceutical-grade marihuana in order to facilitate research in a manner that complies with local, state, and federal regulations. No other activities for these drug codes are authorized for this registration.

Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19783 Filed 9-3-24; 8:45 am]
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