Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company, 71930 [2024-19783]
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71930
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
Controlled substance
Drug code
Hydrocodone ..................................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Methadone .....................................................................................................................................................................
Methadone intermediate ................................................................................................................................................
Morphine ........................................................................................................................................................................
Oripavine ........................................................................................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
Tapentadol .....................................................................................................................................................................
Fentanyl .........................................................................................................................................................................
The company plans to bulk
manufacture the listed controlled
substances in bulk for distribution and
sale to its customers. In reference to
drug codes 7360 (Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic. No other activities for
these drug codes are 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
manufacturing of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024–19779 Filed 9–3–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
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9193
9220
9250
9254
9300
9330
9333
9652
9668
9737
9739
9740
9780
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.33(a), this
is notice that on July 17, 2024,
Biopharmaceutical Research Company,
11045 Commercial Parkway, Castroville,
California 95012–3209, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1418]
Bulk Manufacturer of Controlled
Substances Application:
Biopharmaceutical Research Company
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Biopharmaceutical Research
Company has applied to be registered as
a bulk manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
SUMMARY:
Controlled substance
Drug code
Schedule
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
7350
7360
7370
I
I
I
The company plans to bulk
manufacture the listed controlled
substances to provided Pharmaceuticalgrade marihuana in order to facilitate
research in a manner that complies with
local, state, and federal regulations. No
other activities for these drug codes are
authorized for this registration.
DEPARTMENT OF JUSTICE
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
AGENCY:
[FR Doc. 2024–19783 Filed 9–3–24; 8:45 am]
[Docket No. DEA–1411]
Bulk Manufacturer of Controlled
Substances Application: Cambridge
Isotope Laboratories, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
Cambridge Isotope
Laboratories, Inc has applied to be
SUMMARY:
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Drug Enforcement Administration
21:26 Sep 03, 2024
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registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplementary
Information listed below for further
drug information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants, therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before November 4, 2024. Such
persons may also file a written request
for a hearing on the application on or
before November 4, 2024.
DATES:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Page 71930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19783]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1418]
Bulk Manufacturer of Controlled Substances Application:
Biopharmaceutical Research Company
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Biopharmaceutical Research Company has applied to be
registered as a bulk manufacturer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for
further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants, therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
November 4, 2024. Such persons may also file a written request for a
hearing on the application on or before November 4, 2024.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 17, 2024, Biopharmaceutical Research Company,
11045 Commercial Parkway, Castroville, California 95012-3209, applied
to be registered as a bulk manufacturer of the following basic
class(es) of controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances to provided Pharmaceutical-grade marihuana in order to
facilitate research in a manner that complies with local, state, and
federal regulations. No other activities for these drug codes are
authorized for this registration.
Marsha L. Ikner,
Acting Deputy Assistant Administrator.
[FR Doc. 2024-19783 Filed 9-3-24; 8:45 am]
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