[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47521-47522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18233]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-864]


Importer of Controlled Substances Application: Cedarburg 
Pharmaceuticals

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Cedarburg Pharmaceuticals 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 file written

[[Page 47522]]

comments on or objections to the issuance of the proposed registration 
on or before September 24, 2021. Such persons may also file a written 
request for a hearing on the application on or before September 24, 
2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on January 20, 2021, Cedarburg Pharmaceuticals, 870 
Badger Circle Drive, Grafton, Wisconsin 53024-9436, applied to be 
registered as an importer of the following basic class(es) of 
controlled substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Gamma Hydroxybutyric Acid...............    2010  I
Marihuana Extract.......................    7350  I
Marihuana...............................    7360  I
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    The company plans to import Sodium Oxybate (derivative of Gamma-
Hydroxybutyric Acid) to support Euticals Inc. post procurement quota 
grand. The cannabidiol from Marihuana and Marihuana Extracts is 
intended for analytical purposes with tetramethylpyrazine. 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.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-18233 Filed 8-24-21; 8:45 am]
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