81 FR 8246 - Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 32 (February 18, 2016)

Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance.

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8246-8247]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03358]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: Catalent Pharma 
Solutions, LLC

ACTION: Notice of registration.

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SUMMARY: Catalent Pharma Solutions, LLC applied to be registered as an 
importer of a certain basic class of controlled substance. The Drug 
Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC 
registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and 
published in the Federal Register on August 31, 2015, 80 FR 52510, 
Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, 
Pennsylvania 19114 applied to be registered as an importer of a certain 
basic class of controlled substance. No comments or objections were 
submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 
958(a) and determined that the registration of Catalent Pharma 
Solutions, LLC to import the basic class of controlled substance is 
consistent with the public interest and with United States obligations 
under international treaties, conventions, or protocols in effect on 
May 1, 1971. The DEA investigated the company's maintenance of 
effective controls against diversion by inspecting and testing the 
company's physical security systems, verifying the company's compliance 
with state and local laws, and reviewing the company's background and 
history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of hydromorphone (9150), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the above listed controlled substance 
for a clinical trial study. Approval of permit applications will occur 
only when the

[[Page 8247]]

registrant's business activity is consistent with what is authorized 
under to 21 U.S.C. 952(a)(2). Authorization will not extend to the 
import of FDA approved or non-approved finished dosage forms for 
commercial sale.

    Dated: February 10, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03358 Filed 2-17-16; 8:45 am]
 BILLING CODE 4410-09-P