Importer of Controlled Substances Application: Catalent CTS, LLC, 57748 [2019-23502]

Download as PDF 57748 Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices Company FR docket Eli-Elsohly Laboratories ............................................................................. 84 FR 27661 ....................................................... The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of these registrants to manufacture the applicable basic classes of controlled substances 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 each company’s physical security systems, verifying each company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the DEA has granted a registration as a bulk manufacturer to the above listed companies. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–23501 Filed 10–25–19; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Catalent CTS, LLC ACTION: Notice of application. 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 khammond on DSKJM1Z7X2PROD with NOTICES DATES: VerDate Sep<11>2014 16:58 Oct 25, 2019 Jkt 250001 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: Controlled substance Gamma Hydroxybutyric Acid. Marihuana Extract .......... Marihuana ....................... Tetrahydrocannabinols ... Drug code Schedule 2010 I 7350 7360 7370 I I I Published June 13, 2019. Morrissette Drive, Springfield, Virginia 22152. In accordance with 21 CFR 1301.33(a), this is notice that on June 27, 2019, Euticals Inc., 2460 W Bennett Street, Springfield, Missouri 65807–1229 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Gamma Hydroxybutyric Acid. Amphetamine ............... Lisdexamfetamine ........ Methylphenidate ........... Phenylacetone .............. Methadone .................... Methadone intermediate Oripavine ...................... Tapentadol .................... Drug code Schedule 2010 I 1100 1205 1724 8501 9250 9254 9330 9780 II II II II II II II II The company plans to import finished dosage unit products containing gammahydroxybutryic 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 nonapproved finished dosage forms for commercial sale. The company plans to manufacture the above-listed controlled substances in bulk for distribution to its customers. Dated: October 18, 2019. William T. McDermott, Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2019–23502 Filed 10–25–19; 8:45 am] Drug Enforcement Administration Dated: October 18, 2019. William T. McDermott, Assistant Administrator. [FR Doc. 2019–23499 Filed 10–25–19; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P [Docket No. DEA–392] DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Euticals Inc. ACTION: Notice of application. 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 December 27, 2019. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 DATES: PO 00000 Frm 00061 Fmt 4703 [Bulk Manufacturer of Controlled Substances Registration Sfmt 4703 Notice of registration. The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of schedule I and II controlled substances. SUMMARY: The companies listed below applied to be registered as a bulk manufacturers of various classes of scheduled I and II controlled substances. Information on previously published notices is listed below. No comments or objections were submitted for these notices. SUPPLEMENTARY INFORMATION: E:\FR\FM\28OCN1.SGM 28OCN1

Agencies

[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:

------------------------------------------------------------------------
                                          Drug
          Controlled substance            code           Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............    2010  I
Marihuana Extract......................    7350  I
Marihuana..............................    7360  I
Tetrahydrocannabinols..................    7370  I
------------------------------------------------------------------------

    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
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