Notice2021-15919
Importer of Controlled Substances Application: Catalent Pharma Solutions, 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
July 27, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
Catalent Pharma Solutions, 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 141 (Tuesday, July 27, 2021)</title>
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[Federal Register Volume 86, Number 141 (Tuesday, July 27, 2021)]
[Notices]
[Page 40211]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15919]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-866]
Importer of Controlled Substances Application: Catalent Pharma
Solutions, LLC.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Catalent Pharma Solutions, 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 August 26, 2021.
Such persons may also file a written request for a hearing on the
application on or before August 26, 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 June 2, 2021, Catalent Pharma Solutions, LLC., 3031
Red Lion Road, Philadelphia, Pennsylvania 19114, 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
Lysergic Acid Diethylamide.............. 7315 I
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The company plans to import the above controlled substances as
finished dosage unit products for clinical trials, research, and
analytical activities. 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 and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-15919 Filed 7-26-21; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on July 27, 2021.
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