Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc., 67725 [2021-25950]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 226 / Monday, November 29, 2021 / Notices
The company plans to manufacture
bulk controlled substances for use in
analytical testing. In reference to drug
codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
Ingredient (API) for distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Brian S. Besser,
Acting Assistant Administrator.
BILLING CODE 4410–09–P
[FR Doc. 2021–25950 Filed 11–26–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed First
Amendment to Consent Decree
[Docket No. DEA–929]
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: Pisgah
Laboratories Inc.
Drug Enforcement Administration
[Docket No. DEA–930]
Bulk Manufacturer of Controlled
Substances Application: Patheon API
Manufacturing, Inc.
Patheon API Manufacturing,
Inc., has applied to be registered as a
bulk manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
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 January 28, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 3, 2021,
Patheon API Manufacturing, Inc., 309
Delaware Street, Greenville, South
Carolina 29605–5420, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Drug
code
Schedule
7435
7438
I
I
The company plans to bulk
manufacture the listed controlled
substances as an Active Pharmaceutical
VerDate Sep<11>2014
16:55 Nov 26, 2021
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pisgah Laboratories Inc. has
applied to be registered as a bulk
manufacturer of basic class(es) of
controlled substance(s). Refer to
Supplemental Information listed below
for further drug information.
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 January 28, 2022. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2022.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Dimethyltryptamine .........
Psilocyn ..........................
Jkt 256001
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement Administration
BILLING CODE P
Controlled substance
No other activities for these drug codes
are authorized for this registration.
[FR Doc. 2021–25949 Filed 11–26–21; 8:45 am]
DEPARTMENT OF JUSTICE
[FR Doc. 2021–25954 Filed 11–26–21; 8:45 am]
67725
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 30, 2021, Pisgah
Laboratories Inc., 3222 Old
Hendersonville Highway, Pisgah Forest,
North Carolina 28768, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Difenoxin .........................
Methylphenidate .............
Diphenoxylate .................
Levorphanol ....................
Remifentanil ....................
Tapentadol ......................
Drug
code
Schedule
9168
1724
9170
9220
9739
9780
I
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
On November 19, 2021, the
Department of Justice lodged a proposed
First Amendment to Consent Decree
with the United States District Court for
the Western District of Louisiana in the
lawsuit entitled United States et al. v.
Sid Richardson Carbon, Ltd (M.D. La.),
Civil Action No. 3:17–cv–01792.
The Consent Decree, entered by the
Court on August 14, 2018, resolved
claims by the United States, the State of
Texas, and the State of Louisiana
alleging violations of certain Clean Air
Act provisions at three carbon black
manufacturing facilities owned and
operated by Sid Richardson (now
‘‘Tokai’’). The Consent Decree requires
Defendant to reduce harmful SO2, NOX,
and PM emissions through the
installation and operation of pollution
controls. Defendant also agreed to spend
$490,000 to fund environmental
mitigation projects that will further
reduce emissions and benefit
communities adversely affected by the
pollution from the facilities, and pay a
civil penalty of $999,000.
The proposed First Amendment to
Consent Decree would, if entered by the
Court, make modifications to the
Consent Decree to address and resolve
claims by Defendant that force majeure
events caused delays in meeting certain
compliance deadlines at Defendant’s
Borger, Texas facility. The modifications
extend certain deadlines in the Consent
Decree, while maintaining Defendant’s
ultimate obligation to install and
operate pollution controls at its
facilities.
The publication of this notice opens
a period for public comment on the
proposed First Amendment to Consent
Decree. Comments should be addressed
to the Assistant Attorney General,
Environment and Natural Resources
Division, and should refer to United
States et al. v. Sid Richardson Carbon,
Ltd. (M.D. La.), D.J. Ref. No. 90–5–2–1–
10663. All comments must be submitted
no later than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Page 67725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25950]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-930]
Bulk Manufacturer of Controlled Substances Application: Patheon
API Manufacturing, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Patheon API Manufacturing, Inc., has applied to be registered
as a bulk manufacturer of basic class(es) of controlled substance(s).
Refer to Supplemental Information listed below for further drug
information.
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 January 28,
2022. Such persons may also file a written request for a hearing on the
application on or before January 28, 2022.
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 November 3, 2021, Patheon API Manufacturing, Inc.,
309 Delaware Street, Greenville, South Carolina 29605-5420, applied to
be registered as a bulk manufacturer of the following basic class(es)
of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dimethyltryptamine.................................. 7435 I
Psilocyn............................................ 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture the 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-25950 Filed 11-26-21; 8:45 am]
BILLING CODE P
