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Importer of Controlled Substances Application: Aphena Pharma Solutions MD, LLC
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이 매체는 공공·자유 라이선스로 본문을 직접 표시합니다.AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Aphena Pharma Solutions MD, 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 July 17, 2026. Such persons may also file a written request for a hearing on the application on or before July 17, 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 May 21, 2026, Aphena Pharma Solutions MD, LLC, 7978 Industrial Park Road, Easton, Maryland 21601-8600, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
The company plans to import the above listed controlled substance for internal use in the manufacturing of a Food and Drug Administration (FDA)-approved exempt over the counter drug product. 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 an FDA-approved or non-approved finished dosage forms for commercial sale.
Thomas Prevoznik,
Deputy Assistant Administrator.
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