Document

Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc.

Irvine Labs Inc. 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 d...

Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1627]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Irvine Labs Inc. 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 January 26, 2026. Such persons may also file a written request for a hearing on the application on or before January 26, 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 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 October 29, 2025, Irvine Labs Inc., 7305 Murdy Circle, Huntington Beach, California 92647-3533, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
Ibogaine 7260 I
Lysergic acid diethylamide 7315 I
Mescaline 7381 I
Peyote 7415 I
Diethyltryptamine 7434 I
Dimethyltryptamine 7435 I
Psilocybin 7437 I
Psilocyn 7438 I

The company plans to bulk manufacture the above listed controlled substances for research and development purposes internally and for distribution to its research customers. No other activities for these drug codes are authorized for this registration.

Justin Wood,

Acting Deputy Assistant Administrator.

[FR Doc. 2025-21187 Filed 11-25-25; 8:45 am]

BILLING CODE P

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

90 FR 54385

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc.,” thefederalregister.org (November 26, 2025), https://thefederalregister.org/documents/2025-21187/bulk-manufacturer-of-controlled-substances-application-irvine-labs-inc.