Controlled Substance Importer Registration Application - Pharmaron Manufacturing Services

Regulations.gov Final Notices

Published March 27th, 2026

Detected April 6th, 2026

Summary

The DEA published notice that Pharmaron Manufacturing Services (US) LLC applied on February 10, 2026, to be registered as an importer of Poppy Straw Concentrate (Drug Code 9670, Schedule II). The company plans to import the controlled substance to manufacture bulk Active Pharmaceutical Ingredients and for analytical technology transfer. Comments and hearing requests are due April 29, 2026.

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What changed

DEA published a notice of application for Pharmaron Manufacturing Services (US) LLC, located at 498 Washington Street, Coventry, Rhode Island 02816, to be registered as an importer of Poppy Straw Concentrate (Drug Code 9670, Schedule II). The application was filed February 10, 2026. The company intends to use the imported substance for manufacturing commercial bulk Active Pharmaceutical Ingredients and analytical development purposes. No other activity is authorized for this drug code under this registration.

Registrants and applicants may submit electronic comments or objections, and written hearing requests, on or before April 29, 2026. Comments must be submitted electronically through regulations.gov. All hearing requests must be sent to the Hearing Clerk/OALJ and Federal Register Representative at the DEA Springfield, Virginia address. Authorization under this registration does not extend to importing FDA-approved or non-approved finished dosage forms for commercial sale.

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