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Research Triangle Institute Controlled Substance Bulk Manufacturer Registration Application

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Published April 2nd, 2026
Detected April 6th, 2026
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Summary

DEA published notice that Research Triangle Institute applied for bulk manufacturer registration of Tetrahydrocannabinols (Schedule I controlled substance, Drug Code 7370). The company plans to manufacture synthetic THC for research and analytical reference standards. Comments and hearing requests may be submitted until June 2, 2026.

What changed

DEA published notice under 21 CFR 1301.33(a) that Research Triangle Institute, located in Durham, North Carolina, applied on March 3, 2026 to be registered as a bulk manufacturer of Tetrahydrocannabinols (Drug Code 7370, Schedule I). The company seeks to synthetically manufacture this controlled substance for distribution to customers for research and as analytical reference standards only.

Affected parties including registered bulk manufacturers of Schedule I substances may submit electronic comments or objections, and written requests for a hearing, on or before June 2, 2026. Comments must be submitted through regulations.gov. This is a routine registration application notice; no new regulatory obligations are created beyond the standard comment period for third parties to raise objections to the proposed registration.

Source document (simplified)

Content

ACTION:

Notice of application.

SUMMARY:

Research Triangle Institute has applied to be registered as a bulk manufacturer 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 June 2, 2026. Such persons may also file a written
request for a hearing on the application on or before June 2, 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.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(a), this is notice that on March 3, 2026, Research Triangle Institute, 3040 East Cornwallis
Road, Hermann Building, Room 106, Durham, North Carolina 27713, applied to be registered as a bulk manufacturer of the following
basic class(es) of controlled substance(s):

| Controlled substance | Drug code | Schedule |
| --- | --- | --- |
| Tetrahydrocannabinols | 7370 | I |
The company plans to bulk manufacture the listed controlled substance synthetically for distribution to its customers for
research and as analytical reference standards. No other activity for this drug code is authorized for this registration.

Thomas Prevoznik, Deputy Assistant Administrator. [FR Doc. 2026-06522 Filed 4-2-26; 8:45 am] BILLING CODE 4410-09-P

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CFR references

21 CFR 1301.33(a)

Classification

Agency
DEA
Published
April 2nd, 2026
Comment period closes
June 2nd, 2026 (57 days)
Instrument
Consultation
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
FR Doc. 2026-06522
Docket
DEA-2026-0562-0001

Who this affects

Applies to
Drug manufacturers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Controlled Substance Manufacturing DEA Registration
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Controlled Substances Drug Manufacturing DEA Registration

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