Leading Pharma LLC Controlled Substances Importer Application Notice
Summary
The DEA published notice that Leading Pharma LLC, located in Fairfield, New Jersey, applied on March 25, 2026 to be registered as an importer of Diphenoxylate (Drug Code 9170, Schedule II). The company plans to import the controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for FDA approval. Registered bulk manufacturers and applicants may submit comments or objections on or before May 21, 2026.
“The company plans to import the listed controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for Food and Drug Administration approval.”
What changed
The DEA published a notice of application under 21 CFR 1301.34(a) for Leading Pharma LLC to register as an importer of Diphenoxylate, a Schedule II controlled substance. The application was received March 25, 2026. The notice invites electronic comments and written hearing requests from registered bulk manufacturers and other interested parties. The public comment and hearing request deadline is May 21, 2026.
For competitors and industry participants in the pharmaceutical controlled substance import space, this notice represents a routine regulatory filing opportunity. No person or entity is required to take action unless they wish to object to the issuance of the proposed registration. Those choosing to comment must submit electronically through Regulations.gov or send written hearing requests to the DEA Hearing Clerk and Federal Register Representative at the Springfield, Virginia address listed.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Content
ACTION:
Notice of application.
SUMMARY:
Leading Pharma 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 May 21, 2026. Such persons may also file a written
request for a hearing on the application on or before May 21, 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 25, 2026, Leading Pharma LLC, 3 Oak Road, Fairfield, New
Jersey 07004, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug
code | Schedule |
| --- | --- | --- |
| Diphenoxylate | 9170 | II |
The company plans to import the listed controlled substance as an active pharmaceutical ingredient for research and development
toward manufacturing a finished dosage product for Food and Drug Administration approval. 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. 2026-07696 Filed 4-20-26; 8:45 am] BILLING CODE P
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