Indivior Manufacturing LLC Controlled Substances Importer Application

FR: Drug Enforcement Administration

Published April 1st, 2026

Detected April 1st, 2026

Summary

The Drug Enforcement Administration published notice that Indivior Manufacturing LLC (Raleigh, NC) applied to be registered as an importer of Thebaine (drug code 9333, Schedule II controlled substance). The company plans to import the controlled substance for research, clinical trials, analytical purposes, and manufacturing process development. The public comment period closes May 1, 2026.

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What changed

DEA published notice of application from Indivior Manufacturing LLC to be registered as importer of Thebaine (drug code 9333, Schedule II). The application was filed February 26, 2026, at the company's address at 8900 Capital Boulevard, Raleigh, NC 27616. No other activity for this drug code is authorized for this registration.

Interested parties may submit electronic comments or written objections on or before May 1, 2026. Requests for hearings on the application must also be submitted by May 1, 2026. If approved, authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale—only limited quantity imports for research, clinical trials, analytical purposes, and dosage form manufacturing process development are permitted.

What to do next

Review the application details for Indivior Manufacturing LLC's importer registration request
Submit electronic comments or objections to the registration application through regulations.gov by May 1, 2026
File written request for hearing if desired by May 1, 2026

Source document (simplified)

Notice

Importer of Controlled Substances Application: Indivior Manufacturing LLC

A Notice by the Drug Enforcement Administration on 04/01/2026

This document has a comment period that ends in 30 days.
(05/01/2026) View Comment Instructions
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Public Inspection Published Document: 2026-06259 (91 FR 16237) Document Headings ###### Department of Justice

Drug Enforcement Administration

[Docket No. DEA-1697]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Indivior Manufacturing LLC has applied to be registered as an importer 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 May 1, 2026. Such persons may also file a written request for a hearing on the application on or before May 1, 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. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on February 26, 2026, Indivior Manufacturing LLC, 8900 Capital Boulevard, Raleigh, North Carolina 27616, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Thebaine | 9333 | II |
The company plans to import a derivative of the above listed controlled substance(s) in limited quantity for research, clinical trials, analytical purposes, and for the manufacturing process development of the dosage form. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

Thomas Prevoznik,

Deputy Assistant Administrator.

[FR Doc. 2026-06259 Filed 3-31-26; 8:45 am]

BILLING CODE P

Published Document: 2026-06259 (91 FR 16237)