Indivior Manufacturing LLC - Controlled Substances Importer Registration Application

Regs.gov: Drug Enforcement Administration

Published February 26th, 2026

Detected April 2nd, 2026

Summary

The DEA published notice that Indivior Manufacturing LLC applied on February 26, 2026, to be registered as an importer of Thebaine (drug code 9333, Schedule II controlled substance). The company plans to import limited quantities for research, clinical trials, analytical purposes, and manufacturing process development of dosage forms. The public comment period closes on May 1, 2026.

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What changed

The DEA published a notice of application under 21 CFR 1301.34(a) indicating that Indivior Manufacturing LLC (8900 Capital Boulevard, Raleigh, NC 27616) seeks registration as a Schedule II controlled substance importer for Thebaine. The application specifically authorizes import for research, clinical trials, analytical purposes, and manufacturing process development only—no commercial sale of FDA-approved or non-approved finished dosage forms is permitted.

Registered bulk manufacturers of the affected controlled substance class and other interested parties may submit electronic comments or written hearing requests on or before May 1, 2026. Comments must be submitted via regulations.gov; hearing requests must be sent to the DEA Hearing Clerk/OALJ and DEA Federal Register Representative at the Springfield, VA address. Registration approval will occur only when the registrant's activity aligns with 21 U.S.C. 952(a)(2) authorization limits.

Source document (simplified)

Content

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