[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Page 57748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23502]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent CTS, LLC

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before November 27, 2019. 
Such persons may also file a written request for a hearing on the 
application on or before November 27, 2019.

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 
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 July 16, 2019, Catalent CTS, LLC, 10245 Hickman Mills 
Drive, Kansas City, Missouri 64137-1418 applied to be registered as an 
importer of the following basic classes of controlled substances:

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                                          Drug
          Controlled substance            code           Schedule
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Gamma Hydroxybutyric Acid..............    2010  I
Marihuana Extract......................    7350  I
Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
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    The company plans to import finished dosage unit products 
containing gamma-hydroxybutryic acid and marihuana extracts for 
clinical trial studies. These marihuana extracts compounds are listed 
under drug code 7350. 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 FDA-approved or non-approved finished dosage forms for commercial 
sale.

    Dated: October 18, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-23502 Filed 10-25-19; 8:45 am]
 BILLING CODE 4410-09-P