Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc., 25703-25704 [2023-08859]
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25703
Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
Controlled substance
Drug code
lotter on DSK11XQN23PROD with NOTICES1
beta-Methyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide; also known as b-methyl fentanyl) ........
Zipeprol (1-methoxy-3[-4-(2-methoxy-2-phenylethyl)piperazin-1-yl]-1-phenylpropan-2-ol) ....................................................
Phenmetrazine .......................................................................................................................................................................
Methylphenidate .....................................................................................................................................................................
Amobarbital ............................................................................................................................................................................
Pentobarbital ..........................................................................................................................................................................
Secobarbital ............................................................................................................................................................................
Glutethimide ...........................................................................................................................................................................
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration ........
Nabilone .................................................................................................................................................................................
1-Phenylcyclohexylamine .......................................................................................................................................................
Phencyclidine .........................................................................................................................................................................
ANPP (4-Anilino-N-phenethyl-4-piperidine) ............................................................................................................................
Norfentanyl (N-phenyl-N-(piperidin-4-yl) propionamide) ........................................................................................................
Phenylacetone ........................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile .......................................................................................................................................
Alphaprodine ..........................................................................................................................................................................
Anileridine ...............................................................................................................................................................................
Coca Leaves ..........................................................................................................................................................................
Cocaine ..................................................................................................................................................................................
Etorphine HCl .........................................................................................................................................................................
Dihydrocodeine .......................................................................................................................................................................
Diphenoxylate .........................................................................................................................................................................
Ecgonine .................................................................................................................................................................................
Ethylmorphine .........................................................................................................................................................................
Levomethorphan .....................................................................................................................................................................
Levorphanol ............................................................................................................................................................................
Isomethadone .........................................................................................................................................................................
Meperidine ..............................................................................................................................................................................
Meperidine intermediate-A .....................................................................................................................................................
Meperidine intermediate-B .....................................................................................................................................................
Meperidine intermediate-C .....................................................................................................................................................
Metazocine .............................................................................................................................................................................
Oliceridine (N-[(3-methoxythiophen-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro[4.5] decan-9-yl] ethyl {time})amine fumarate).
Metopon ..................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) .....................................................................................................................
Dihydroetorphine ....................................................................................................................................................................
Opium tincture ........................................................................................................................................................................
Opium, powdered ...................................................................................................................................................................
Opium, granulated ..................................................................................................................................................................
Noroxymorphone ....................................................................................................................................................................
Phenazocine ...........................................................................................................................................................................
Thiafentanil .............................................................................................................................................................................
Piminodine ..............................................................................................................................................................................
Racemethorphan ....................................................................................................................................................................
Racemorphan .........................................................................................................................................................................
Alfentanil .................................................................................................................................................................................
Remifentanil ............................................................................................................................................................................
Sufentanil ................................................................................................................................................................................
Carfentanil ..............................................................................................................................................................................
Tapentadol ..............................................................................................................................................................................
Bezitramide .............................................................................................................................................................................
Moramide-intermediate ...........................................................................................................................................................
The company plans to import small
quantities of the listed controlled
substances for the National Institute on
Drug Abuse for research activities. The
company plans to import analytical
reference standards for distribution to
its customers for research and analytical
purposes. 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
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of Food and Drug
VerDate Sep<11>2014
17:49 Apr 26, 2023
Jkt 259001
Schedule
9856
9873
1631
1724
2125
2270
2315
2550
7365
7379
7460
7471
8333
8366
8501
8603
9010
9020
9040
9041
9059
9120
9170
9180
9190
9210
9220
9226
9230
9232
9233
9234
9240
9245
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
9260
9273
9334
9630
9639
9640
9668
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9802
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Administration-approved or nonapproved finished dosage forms for
commercial sale.
DEPARTMENT OF JUSTICE
Matthew Strait,
Deputy Assistant Administrator.
[Docket No. DEA–1186]
[FR Doc. 2023–08857 Filed 4–26–23; 8:45 am]
Bulk Manufacturer of Controlled
Substances Application: Pisgah
Laboratories Inc.
BILLING CODE 4410–09–P
PO 00000
Drug Enforcement Administration
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Pisgah Laboratories Inc., has
applied to be registered as a bulk
SUMMARY:
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E:\FR\FM\27APN1.SGM
27APN1
25704
Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
manufacturer of basic class(es) of
controlled substance(s). Refer to
SUPPLEMENTARY INFORMATION listed
below for further drug information.
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
ADDRESSES:
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 June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 2023.
DATES:
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on March 13, 2023, 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
Drug code
4-Bromo-2,5-dimethoxyphenethylamine ................................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ............................................................................................................
Difenoxin ................................................................................................................................................................................
Amphetamine .........................................................................................................................................................................
Lisdexamfetamine ..................................................................................................................................................................
Methylphenidate ....................................................................................................................................................................
Diphenoxylate ........................................................................................................................................................................
Meperidine .............................................................................................................................................................................
Methadone .............................................................................................................................................................................
The company plans to bulk
manufacture the above-listed controlled
substances in bulk for internal research
purposes and distribution to its
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–08859 Filed 4–26–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1182]
Importer of Controlled Substances
Application: AndersonBrecon, Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
AndersonBrecon, Inc. has
applied to be registered as an importer
SUMMARY:
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 May 30, 2023. Such persons
may also file a written request for a
hearing on the application on or before
May 30, 2023.
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
Drug code
lotter on DSK11XQN23PROD with NOTICES1
Tetrahydrocannabinols ..........................................................................................................................................................
3,4-Methylenedioxymethamphetamine ..................................................................................................................................
VerDate Sep<11>2014
17:49 Apr 26, 2023
Jkt 259001
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
import of Food and Drug
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
I
I
I
II
II
II
II
II
II
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. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on March 7, 2023,
AndersonBrecon, Inc., 4545 Assembly
Drive, Rockford, Illinois 61109–3081,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Controlled substance
The company plans to import the
listed controlled substances for clinical
trials studies only. No other activities
for these drug codes are authorized for
this registration.
7392
7540
9168
1100
1205
1724
9170
9230
9250
Schedule
7370
7405
Administration-approved or
E:\FR\FM\27APN1.SGM
27APN1
Schedule
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]]>Agencies
[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25703-25704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08859]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1186]
Bulk Manufacturer of Controlled Substances Application: Pisgah
Laboratories Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Pisgah Laboratories Inc., has applied to be registered as a
bulk
[[Page 25704]]
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
June 26, 2023. Such persons may also file a written request for a
hearing on the application on or before June 26, 2023.
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 March 13, 2023, 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):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
4-Bromo-2,5-dimethoxyphenethylamine.. 7392 I
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Difenoxin............................ 9168 I
Amphetamine.......................... 1100 II
Lisdexamfetamine..................... 1205 II
Methylphenidate...................... 1724 II
Diphenoxylate........................ 9170 II
Meperidine........................... 9230 II
Methadone............................ 9250 II
------------------------------------------------------------------------
The company plans to bulk manufacture the above-listed controlled
substances in bulk for internal research purposes and distribution to
its customers. No other activities for these drug codes are authorized
for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-08859 Filed 4-26-23; 8:45 am]
BILLING CODE 4410-09-P
