[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Page 34465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12086]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-652]


Importer of Controlled Substances Application: Catalent Pharma 
Solutions, LLC

ACTION: Notice of application.

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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 July 6, 2020. 
Such persons may also file a written request for a hearing on the 
application on or before July 6, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration (DEA), 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 May 8, 2020, 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:

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                                           Drug
          Controlled substance             code          Schedule
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Gamma Hydroxybutyric Acid..............    2010   I
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    The company plans to import finished dosage unit products 
containing Gamma Hydroxybutyric Acid for clinical trials, research, and 
analytical activities. 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 the Food and Drug Administration (FDA)-approved 
or non-approved finished dosage forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-12086 Filed 6-3-20; 8:45 am]
 BILLING CODE 4410-09-P