Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Mountain Trading LLC, 9537 [2021-02970]
Download as PDF
<![CDATA[
9537
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
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 March 18, 2021. Such persons
may also file a written request for a
hearing on the application on or before
March 18, 2021.
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 January 14, 2021,
Noramco Coventry LLC, 498
Washington Street, Coventry, Rhode
Island 02816, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
khammond on DSKJM1Z7X2PROD with NOTICES
Tetrahydrocannabinols .........
Methylphenidate ....................
Oxycodone ............................
Hydromorphone ....................
Hydrocodone .........................
Morphine ...............................
Opium, raw ...........................
Oxymorphone .......................
Poppy Straw Concentrate .....
Drug
code
7370
1724
9143
9150
9193
9300
9600
9652
9670
Schedule
I
II
II
II
II
II
II
II
II
The company (formerly known as
Rhodes Technologies) plans to import
Opium, raw (9600), and Poppy Straw
Concentrate (9670) in order to bulk
manufacture controlled substances in
Active Pharmaceutical Ingredient (API)
form. The company distributes the
manufactured APIs in bulk to its
customers. The company plans to
import the other listed controlled
substances for internal reference
standards use only. The comparisons of
foreign reference standards to the
company’s domestically manufactured
API will allow the company to export
domestically manufactured API to
foreign markets. No other activity for
this drug code is authorized for this
registration.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
VerDate Sep<11>2014
20:13 Feb 12, 2021
Jkt 253001
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02971 Filed 2–12–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–774]
Bulk Manufacturer of Controlled
Substances Application: Bulk
Manufacturer of Marihuana: Mountain
Trading LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
The Drug Enforcement
Administration (DEA) is providing
notice of an application it has received
from an entity applying to be registered
to manufacture in bulk basic class(es) of
controlled substances listed in schedule
I. DEA intends to evaluate this and other
pending applications according to its
regulations governing the program of
growing marihuana for scientific and
medical research under DEA
registration.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefor, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 19, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. To ensure proper handling of
comments, please reference Docket No.
DEA–774 in all correspondence,
including attachments.
SUPPLEMENTARY INFORMATION: The
Controlled Substances Act (CSA)
prohibits the cultivation and
distribution of marihuana except by
persons who are registered under the
CSA to do so for lawful purposes. In
accordance with the purposes specified
in 21 CFR 1301.33(a), DEA is providing
notice that the entity identified below
has applied for registration as a bulk
manufacturer of schedule I controlled
substances. In response, registered bulk
manufacturers of the affected basic
class(es), and applicants therefor, may
file written comments on or objections
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
of the requested registration, as
provided in this notice. This notice does
not constitute any evaluation or
determination of the merits of the
application submitted.
The applicant plans to manufacture
bulk active pharmaceutical ingredients
(APIs) for product development and
distribution to DEA-registered
researchers. If the application for
registration is granted, the registrant
would not be authorized to conduct
other activity under this registration
aside from those coincident activities
specifically authorized by DEA
regulations. DEA will evaluate the
application for registration as a bulk
manufacturer for compliance with all
applicable laws, treaties, and
regulations and to ensure adequate
safeguards against diversion are in
place.
As this applicant has applied to
become registered as a bulk
manufacturer of marihuana, the
application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will
conduct this evaluation in the manner
described in the rule published at 85 FR
82333 on December 18, 2020, and
reflected in DEA regulations at 21 CFR
part 1318.
In accordance with 21 CFR
1301.33(a), DEA is providing notice that
on November 30, 2018, Mountain
Trading LLC, 6 South 89 Street West,
Billings, Montana 59106, applied to be
registered as a manufacturer, and on
January 14, 2021, the application was
changed from a manufacturer to a bulk
manufacturer, of the following basic
class(es) of controlled substances:
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
Drug
code
7360
7370
Schedule
I
I
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–02970 Filed 2–12–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–787]
Importer of Controlled Substances
Application: Sigma Aldrich Co., LLC.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Sigma Aldrich Co. LLC. has
applied to be registered as an importer
SUMMARY:
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Page 9537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02970]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-774]
Bulk Manufacturer of Controlled Substances Application: Bulk
Manufacturer of Marihuana: Mountain Trading LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is providing notice
of an application it has received from an entity applying to be
registered to manufacture in bulk basic class(es) of controlled
substances listed in schedule I. DEA intends to evaluate this and other
pending applications according to its regulations governing the program
of growing marihuana for scientific and medical research under DEA
registration.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefor, may file written comments on or objections to
the issuance of the proposed registration on or before April 19, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper
handling of comments, please reference Docket No. DEA-774 in all
correspondence, including attachments.
SUPPLEMENTARY INFORMATION: The Controlled Substances Act (CSA)
prohibits the cultivation and distribution of marihuana except by
persons who are registered under the CSA to do so for lawful purposes.
In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is
providing notice that the entity identified below has applied for
registration as a bulk manufacturer of schedule I controlled
substances. In response, registered bulk manufacturers of the affected
basic class(es), and applicants therefor, may file written comments on
or objections of the requested registration, as provided in this
notice. This notice does not constitute any evaluation or determination
of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical
ingredients (APIs) for product development and distribution to DEA-
registered researchers. If the application for registration is granted,
the registrant would not be authorized to conduct other activity under
this registration aside from those coincident activities specifically
authorized by DEA regulations. DEA will evaluate the application for
registration as a bulk manufacturer for compliance with all applicable
laws, treaties, and regulations and to ensure adequate safeguards
against diversion are in place.
As this applicant has applied to become registered as a bulk
manufacturer of marihuana, the application will be evaluated under the
criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the
manner described in the rule published at 85 FR 82333 on December 18,
2020, and reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that
on November 30, 2018, Mountain Trading LLC, 6 South 89 Street West,
Billings, Montana 59106, applied to be registered as a manufacturer,
and on January 14, 2021, the application was changed from a
manufacturer to a bulk manufacturer, of the following basic class(es)
of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
------------------------------------------------------------------------
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-02970 Filed 2-12-21; 8:45 am]
BILLING CODE 4410-09-P
