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Pharmaron Manufacturing Services DEA Importer Controlled Substances Application

Favicon for www.regulations.gov Regs.gov: Drug Enforcement Administration
Published March 27th, 2026
Detected March 30th, 2026
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Summary

The Drug Enforcement Administration (DEA) has published a notice regarding an application from Pharmaron Manufacturing Services (US) LLC to be registered as an importer of Poppy Straw Concentrate (Schedule II). Interested parties may submit comments or requests for a hearing by April 29, 2026.

What changed

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from Pharmaron Manufacturing Services (US) LLC to import Poppy Straw Concentrate (Schedule II). This application is for the purpose of manufacturing commercial bulk Active Pharmaceutical Ingredients and for analytical technology transfer and development. The notice serves as a public announcement, allowing registered bulk manufacturers and other interested parties to submit electronic comments or written requests for a hearing.

Compliance officers should note the comment and hearing request deadline of April 29, 2026. Pharmaron Manufacturing Services plans to import bulk substances for API manufacturing and analytical purposes, with authorization not extending to finished dosage forms for commercial sale. The DEA will review the application to ensure business activity aligns with statutory requirements.

What to do next

  1. Submit electronic comments or written requests for a hearing by April 29, 2026.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Pharmaron Manufacturing Services (US) 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 29, 2026. Such persons may also file a written
request for a hearing on the application on or before April 29, 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 10, 2026, Pharmaron Manufacturing Services (US) LLC,
498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as an importer of the following basic class(es)
of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Poppy Straw Concentrate | 9670 | II |
The company plans to import bulk substances to manufacture commercial bulk Active Pharmaceutical Ingredients as well as for
the purpose of analytical technology transfer and analytical development. 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. 2026-06053 Filed 3-27-26; 8:45 am] BILLING CODE P

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CFR references

21 CFR 1301.34(a)

Classification

Agency
DEA
Published
March 27th, 2026
Comment period closes
April 29th, 2026 (30 days)
Compliance deadline
April 29th, 2026 (30 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Substantive
Document ID
FR Doc. 2026-06053
Docket
DEA-2026-0498-0001

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Importing Controlled Substances API Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Import/Export

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