Importer of Controlled Substances Application: Alcami Carolinas Corporation, 26715 [2020-09552]

Download as PDF 26715 Federal Register / Vol. 85, No. 87 / Tuesday, May 5, 2020 / Notices Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–635] Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute ACTION: Notice of application. 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. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice that on March 4, 2020, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: DATES: Controlled substance Drug code In accordance with 21 CFR 1301.33(a), this is notice that on February 21, 2020, Patheon A PI Manufacturing, Inc, 309 Delaware Street, Greenville, South Carolina 29605, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance Drug code Gamma Hydroxybutyric Acid. Alpha-methyltryptamine Thebaine ....................... Noroxymorphone .......... Schedule 2010 I 7432 9333 9668 I II II The company plans to bulk manufacture the above-listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. No other activities for these drug codes are authorized for this registration. William T. McDermott, Assistant Administrator. [FR Doc. 2020–09556 Filed 5–4–20; 8:45 am] BILLING CODE 4410–09–P 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 March 13, 2020, Alcami Carolinas Corporation, 1726 North 23rd Street, Wilmington, North Carolina 28405–1822, applied to be registered as an importer of the following basic class(es) of controlled substances: Controlled substance Drug code Psilocybin ...................... Psilocyn ......................... Thebaine ....................... Pentobarbital ................. 7437 7438 9333 2270 Schedule I I II II The company plans to import the listed controlled substances in bulk for the manufacturing of capsules/tablets for Phase II clinical trials. Approval of permit applications will occur only when the registrant’s activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDAapproved or non-approved finished dosage forms for commercial sale. William T. McDermott, Assistant Administrator. [FR Doc. 2020–09552 Filed 5–4–20; 8:45 am] Schedule BILLING CODE 4410–09–P Tetrahydrocannabinols 7370 DEPARTMENT OF JUSTICE I The purpose for the bulk manufacturing of the controlled substance is for the preparation and the sale of small quantities of Tetrahydrocannabinols (7370), which will be manufactured by synthesis for use by customers as analytical reference standards. William T. McDermott, Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–636] khammond on DSKJM1Z7X2PROD with NOTICES Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc. Notice of application. 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. DATES: VerDate Sep<11>2014 19:16 May 04, 2020 [Docket No. DEA–626] ACTION: Jkt 250001 Notice of application. 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 June 4, 2020. Such persons may also file a written request for a hearing on the application on or before June 4, 2020. 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 request for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette PO 00000 Frm 00060 Fmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances Application: Alcami Carolinas Corporation DATES: [FR Doc. 2020–09555 Filed 5–4–20; 8:45 am] ACTION: Drug Enforcement Administration Sfmt 4703 [Docket No. DEA–611] Importer of Controlled Substances Application: Unither Manufacturing LLC ACTION: Notice of application. 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 June 4, 2020. Such persons may also file a written request for a hearing on the application on or before June 4, 2020. 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 DATES: E:\FR\FM\05MYN1.SGM 05MYN1

Agencies

[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Page 26715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09552]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-626]


Importer of Controlled Substances Application: Alcami Carolinas 
Corporation

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 June 4, 2020. 
Such persons may also file a written request for a hearing on the 
application on or before June 4, 2020.

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 
request 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 March 13, 2020, Alcami Carolinas Corporation, 1726 
North 23rd Street, Wilmington, North Carolina 28405-1822, applied to be 
registered as an importer of the following basic class(es) of 
controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Psilocybin...........................         7437  I
Psilocyn.............................         7438  I
Thebaine.............................         9333  II
Pentobarbital........................         2270  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
bulk for the manufacturing of capsules/tablets for Phase II clinical 
trials. Approval of permit applications will occur only when the 
registrant's 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.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-09552 Filed 5-4-20; 8:45 am]
 BILLING CODE 4410-09-P
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