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Controlled Substance Importer Registration Application - MDMA

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Summary

The DEA published notice that Fisher Clinical Services, Inc. applied on March 11, 2026 to be registered as an importer of 3,4-Methylenedioxy-methamphetamine (MDMA, Schedule I, drug code 7405) for clinical trials only. The company is located in Allentown, Pennsylvania. Registered bulk manufacturers and applicants may submit comments or objections, or request a hearing, by May 1, 2026.

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What changed

The DEA published a notice of application under 21 CFR 1301.34(a) announcing that Fisher Clinical Services, Inc. (7554 Schantz Road, Allentown, PA) applied on March 11, 2026 to be registered as an importer of Schedule I controlled substance 3,4-Methylenedioxy-methamphetamine (drug code 7405). The company plans to import the substance for clinical trials only. No other activity is authorized for this registration, and authorization does not extend to FDA-approved or non-approved finished dosage forms for commercial sale.

Registered bulk manufacturers of the affected basic class(es) and applicants may submit electronic comments or objections, or file written requests for a hearing, on or before May 1, 2026. All hearing requests must be sent to the Hearing Clerk/OALJ and the DEA Federal Register Representative at 8701 Morrissette Drive, Springfield, VA 22152. No specific penalties are mentioned for non-response.

Archived snapshot

Apr 2, 2026

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Content

ACTION:

Notice of application.

SUMMARY:

Fisher Clinical Services, Inc. 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 March 11, 2026, Fisher Clinical Services, Inc., 7554 Schantz
Road, Allentown, Pennsylvania 18106-9032, applied to be registered as an importer of the following basic class(es) of controlled
substance(s):

Controlled substance Drug code Schedule
3,4-Methylenedioxy-methamphetamine 7405 I

The company plans to import the listed controlled substance(s) for clinical trials 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. 2026-06257 Filed 3-31-26; 8:45 am] BILLING CODE P

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CFR references

21 CFR 1301.34(a)

Named provisions

Importer Registration - Basic Class(es) of Controlled Substance(s)

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Last updated

Classification

Agency
DEA
Published
March 31st, 2026
Comment period closes
May 1st, 2026 (14 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Draft
Change scope
Minor
Docket
DEA-2026-0532

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies Importers and exporters
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled Substance Import Registration
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Healthcare Importers and exporters

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