Notice2021-17310
Importer of Controlled Substances Application: Catalent CTS, LLC
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 13, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Catalent CTS, 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.
Full Text
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<title>Federal Register, Volume 86 Issue 154 (Friday, August 13, 2021)</title>
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[Federal Register Volume 86, Number 154 (Friday, August 13, 2021)]
[Notices]
[Pages 44749-44750]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17310]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-883]
Importer of Controlled Substances Application: Catalent CTS, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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[[Page 44750]]
SUMMARY: Catalent CTS, 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 file written comments on or objections to
the issuance of the proposed registration on or before September 13,
2021. Such persons may also file a written request for a hearing on the
application on or before September 13, 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
request 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 July 9, 2021, Catalent CTS, LLC., 10245 Hickman Mills
Drive, Kansas City, Missouri 64137-1418, 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 1
Marihuana............................... 7360 1
Tetrahydrocannabinols................... 7370 I
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The company plans to import the above controlled substances as
dosage unit products for clinical trial studies. No other activity for
these drug codes 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 Drug Administration-approved or non-approved finished dosage
forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17310 Filed 8-12-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on August 13, 2021.
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