Bulk Manufacturer of Controlled Substances Application: Organix Inc., 56633 [2020-20162]
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56633
Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices
Controlled substance
Drug code
Beta-hydroxyfentanyl .............................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ..............................................................................................................................................
Alpha-methylthiofentanyl .......................................................................................................................................................
3-Methylthiofentanyl ...............................................................................................................................................................
Thiofentanyl ...........................................................................................................................................................................
Fentanyl related-substances as defined in 21 CFR 1308.11(h) ...........................................................................................
Methamphetamine .................................................................................................................................................................
Methylphenidate ....................................................................................................................................................................
Amobarbital ............................................................................................................................................................................
Pentobarbital ..........................................................................................................................................................................
Secobarbital ...........................................................................................................................................................................
Glutethimide ...........................................................................................................................................................................
Nabilone .................................................................................................................................................................................
1-Phenylcyclohexylamine ......................................................................................................................................................
Phencyclidine .........................................................................................................................................................................
Phenylacetone .......................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ......................................................................................................................................
Alphaprodine ..........................................................................................................................................................................
Dihydrocodeine ......................................................................................................................................................................
Ecgonine ................................................................................................................................................................................
Ethylmorphine ........................................................................................................................................................................
Levomethorphan ....................................................................................................................................................................
Levorphanol ...........................................................................................................................................................................
Meperidine .............................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ....................................................................................................................
Levo-alphacetylmethadol .......................................................................................................................................................
Noroxymorphone ...................................................................................................................................................................
Racemethorphan ...................................................................................................................................................................
Alfentanil ................................................................................................................................................................................
Remifentanil ...........................................................................................................................................................................
Sufentanil ...............................................................................................................................................................................
Carfentanil .............................................................................................................................................................................
Tapentadol .............................................................................................................................................................................
The company plans to import the
listed controlled substances for the
manufacturing of analytical reference
standards and distribution to their
research and forensic customers.
Approval of permit application 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 Food
and Drug Administration-approved or
non-approved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–20159 Filed 9–11–20; 8:45 am]
BILLING CODE P
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 November 13, 2020 Such
persons may also file a written request
for a hearing on the application on or
before November 13, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 5, 2020,
Organix Inc., 240 Salem Street, Woburn,
Massachusetts 01801–2029, applied to
be registered as a bulk manufacturer of
the following basic class(es) of a
controlled substance(s):
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. DEA–712]
Bulk Manufacturer of Controlled
Substances Application: Organix Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Organix Inc. has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
Controlled substance
Drug code
5-Methoxy-N-Ndimethyltryptamine.
7431
Schedule
I
SUMMARY:
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The company plans to synthesize the
above-listed controlled substance for
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Schedule
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distribution to its customers. No other
activity for this drug code is authorized
for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–20162 Filed 9–11–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–709]
Bulk Manufacturer of Controlled
Substances Application: Cambridge
Isotype Lab
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Cambridge Isotype Lab 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(s) 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 November 13, 2020. Such
SUMMARY:
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20162]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-712]
Bulk Manufacturer of Controlled Substances Application: Organix
Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Organix 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 November 13,
2020 Such persons may also file a written request for a hearing on the
application on or before November 13, 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 August 5, 2020, Organix Inc., 240 Salem Street,
Woburn, Massachusetts 01801-2029, applied to be registered as a bulk
manufacturer of the following basic class(es) of a controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
5-Methoxy-N-N-dimethyltryptamine...... 7431 I
------------------------------------------------------------------------
The company plans to synthesize the above-listed controlled
substance for distribution to its customers. No other activity for this
drug code is authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-20162 Filed 9-11-20; 8:45 am]
BILLING CODE P
