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DEA Notice: Lonza Tampa LLC Application for Controlled Substance Importer Registration

Favicon for www.regulations.gov Regs.gov: Drug Enforcement Administration
Published March 12th, 2026
Detected March 15th, 2026
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Summary

The DEA has published a notice regarding an application from Lonza Tampa, LLC to be registered as an importer of psilocybin (Schedule I controlled substance). Interested parties can submit comments or requests for a hearing by April 13, 2026.

What changed

The Drug Enforcement Administration (DEA) has issued a notice concerning an application filed by Lonza Tampa, LLC for registration as an importer of psilocybin, a Schedule I controlled substance. The application, filed on February 17, 2026, specifies the import of psilocybin as a bulk active pharmaceutical ingredient and in finished dosage units for clinical trials, research, and analytical purposes. This notice serves as an opportunity for registered bulk manufacturers and other applicants to submit comments or objections regarding the proposed registration.

Regulated entities, particularly registered bulk manufacturers of controlled substances, should review this application and consider submitting comments or requests for a hearing by the deadline of April 13, 2026. Comments must be submitted electronically via the Federal eRulemaking Portal. Failure to act by this date may result in the approval of Lonza Tampa, LLC's registration without further objection. This action is relevant for companies involved in the research and development of controlled substances, especially those utilizing psilocybin for clinical trials.

What to do next

  1. Review Lonza Tampa, LLC's application for controlled substance importer registration.
  2. Submit electronic comments or objections to the DEA by April 13, 2026, if applicable.
  3. File a written request for a hearing by April 13, 2026, if applicable.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Lonza Tampa, 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 April 13, 2026. Such persons may also file a written
request for a hearing on the application on or before April 13, 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 17, 2026, Lonza Tampa, LLC, 4901 West Grace Street,
Tampa, Florida 33607-3805, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Psilocybin | 7437 | I |
The company plans to import drug code 7437 (Psilocybin) as bulk active pharmaceutical ingredient and as finished dosage units
for clinical trials, research, 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. 2026-04972 Filed 3-12-26; 8:45 am] BILLING CODE P

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Classification

Agency
DEA
Published
March 12th, 2026
Compliance deadline
April 13th, 2026 (27 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Drug manufacturers
Geographic scope
National (US)

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Drug Importation Clinical Trials

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