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LTS Therapy Systems Importer Registration Application for Schedule I Controlled Substance

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Summary

DEA published notice that LTS Therapy Systems, LLC (West Saint Paul, Minnesota) applied on March 6, 2026 to be registered as an importer of Dimethyltryptamine (Drug code 7435, Schedule I). The company plans to import the controlled substance as bulk API for internal research, development, and analytical purposes only. Registered bulk manufacturers and applicants may submit electronic comments or written hearing requests on or before May 18, 2026.

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What changed

DEA published a notice of application by LTS Therapy Systems, LLC to be registered as an importer of Dimethyltryptamine (Drug code 7435, Schedule I) as a bulk active pharmaceutical ingredient (API) for internal research, development, and analytical purposes only. The registration would not authorize import of FDA-approved or non-approved finished dosage forms for commercial sale. Registered bulk manufacturers of the affected controlled substance class and applicants may submit electronic comments or written hearing requests to DEA on or before May 18, 2026.

Affected parties, including existing registered bulk manufacturers of Schedule I controlled substances and other applicants, may file comments or hearing requests by the May 18, 2026 deadline. Approval of the importer registration will only occur when the registrant's business activity is consistent with authorization under 21 U.S.C. 952(a)(2), and authorization will not extend to commercial sale of finished dosage forms.

Archived snapshot

Apr 22, 2026

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Content

ACTION:

Notice of application.

SUMMARY:

LTS Therapy Systems, 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 18, 2026. Such persons may also file a written
request for a hearing on the application on or before May 18, 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 March 6, 2026, LTS Therapy Systems, LLC, 1685 Marthaler Lane,
West Saint Paul, Minnesota 55118-3517, applied to be registered as an importer of the following basic class(es) of controlled
substance(s):

Controlled substance Drug code Schedule
Dimethyltryptamine 7435 I

The company plans to import the above controlled substance as bulk API for internal research, development, and analytical
purposes only. 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. 2026-07558 Filed 4-16-26; 8:45 am] BILLING CODE P

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CFR references

21 CFR 1301.34(a)

Citations

21 CFR 1301.34(a) authority for application notice
21 U.S.C. 952(a)(2) authorization scope for importer registration

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Last updated

Classification

Agency
DEA
Published
April 16th, 2026
Comment period closes
May 18th, 2026 (26 days)
Compliance deadline
May 18th, 2026 (26 days)
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FR Doc. 2026-07558
Docket
DEA-2026-0665

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled substance importation Importer registration
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Regulatory Affairs
Topics
Anti-Money Laundering

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