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Sterling Wisconsin LLC, controlled substances importer application

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Summary

The Drug Enforcement Administration published a notice that Sterling Wisconsin, LLC applied to be registered as an importer of controlled substances (Drug Code 7431 - 5-Methoxy-N,N-dimethyltryptamine, Schedule I). The company plans to import this substance as bulk Active Pharmaceutical Ingredient for internal research, clinical investigational studies, and analytical purposes. Comments on the application are due May 1, 2026.

What changed

The DEA published a notice of Sterling Wisconsin, LLC's application to be registered as an importer of Schedule I controlled substance 5-Methoxy-N,N-dimethyltryptamine (Drug Code 7431). The applicant intends to import the substance as bulk Active Pharmaceutical Ingredient for internal research, clinical studies, and analytical purposes only—no other activity is authorized. The registration would be governed by 21 CFR 1301.34(a) and limited per 21 U.S.C. 952(a)(2), excluding import of FDA-approved or non-approved finished dosage forms for commercial sale.

Registered bulk manufacturers and applicants may submit electronic comments or objections on or before May 1, 2026, via regulations.gov. Written requests for hearings must be sent to the DEA Hearing Clerk/OALJ and DEA Federal Register Representative at 8701 Morrissette Drive, Springfield, Virginia 22152. Parties interested in the importer application should review the specific substance details and determine whether to file comments or hearing requests by the deadline.

What to do next

  1. Submit comments or objections to Sterling Wisconsin LLC's importer application via regulations.gov by May 1, 2026
  2. File written hearing requests to DEA Hearing Clerk/OALJ if desired by May 1, 2026

Archived snapshot

Apr 1, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Notice

Importer of Controlled Substances Application: Sterling Wisconsin, 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: 2026-06260 (91 FR 16244) Document Headings ###### Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1693]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Sterling Wisconsin, 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 January 27, 2026, Sterling Wisconsin, LLC, W130N10497 Washington Drive, Germantown, Wisconsin 53022-4448, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
5-Methoxy-N,N-dimethyltryptamine 7431 I

The company plans to import this controlled substance as bulk Active Pharmaceutical Ingredient to bulk manufacture in support of internal research, clinical investigational studies, and analytical purposes. 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. 2026-06260 Filed 3-31-26; 8:45 am]

BILLING CODE P

Published Document: 2026-06260 (91 FR 16244)

CFR references

21 CFR 1301.34(a)

Named provisions

Importer of Controlled Substances Application

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Last updated

Classification

Agency
Justice Department
Published
April 1st, 2026
Comment period closes
May 1st, 2026 (16 days)
Compliance deadline
May 1st, 2026 (16 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
91 FR 16244 / Docket No. DEA-1693
Docket
Docket No. DEA-1693

Who this affects

Applies to
Pharmaceutical companies Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled Substance Importing
Threshold
Registered bulk manufacturers of affected controlled substance class(es)
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Healthcare

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