Importer of Controlled Substances Application: Alcami Carolinas Corporation, 26715 [2020-09552]
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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]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-626]
Importer of Controlled Substances Application: Alcami Carolinas
Corporation
ACTION: Notice of application.
-----------------------------------------------------------------------
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
