Quagen Pharmaceuticals LLC Importer Application for Diphenoxylate

Content

ACTION:

Notice of application.

SUMMARY:

Quagen Pharmaceuticals 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 18, 2026. Such persons may also file a written
request for a

hearing on the application on or before May 18, 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 4, 2026, Quagen Pharmaceuticals LLC, 37 Fairfield Place,
West Caldwell, New Jersey 07006, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substance for distribution to its customer. No other activities for these
drug codes are 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. 2026-07559 Filed 4-16-26; 8:45 am] BILLING CODE 4410-09-P

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