Importer of Controlled Substances Application: Catalent Pharma Solutions, LLC
| Published date | 04 June 2020 |
| Citation | 85 FR 34465 |
| Record Number | 2020-12086 |
| Section | Notices |
| Court | Drug Enforcement Administration,Justice Department |
Federal Register, Volume 85 Issue 108 (Thursday, June 4, 2020)
[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
