Importer of Controlled Substances Application: VHG Labs dba LGC Standards, 76084-76086 [2022-26925]
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76084
Federal Register / Vol. 87, No. 237 / Monday, December 12, 2022 / Notices
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 October 7, 2022,
Sterling Pharma USA, LLC, 1001
Sheldon Drive, Suite 101, Cary, North
Carolina 27513–2078, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substance(s):
Controlled substance
5-Methoxy-N-Ndimethyltryptamine.
Psilocybin ........................
Psilocyn ...........................
Drug
code
Schedule
7431
I
7437
7438
I
I
The company plans to manufacture
the above-listed controlled substances
as clinical trials. No other activities for
these drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
Drug
code
Controlled substance
[FR Doc. 2022–26913 Filed 12–9–22; 8:45 am]
Psilocybin .....................
Psilocyn ........................
BILLING CODE P
Drug Enforcement Administration
[Docket No. DEA–1119]
Bulk Manufacturer of Controlled
Substances Application: Scottsdale
Research Institute
7437
7438
I
II
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–26922 Filed 12–9–22; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
BILLING CODE P
Scottsdale Research Institute
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
SUMMARY:
I
Schedule
The company plans to bulk
manufacture the listed controlled
substances for internal research
purposes and to support clinical trials.
No other activities for these drug codes
are authorized for this registration.
DEPARTMENT OF JUSTICE
lotter on DSK11XQN23PROD with NOTICES1
the issuance of the proposed registration
on or before February 10, 2023. Such
persons may also file a written request
for a hearing on the application on or
before February 10, 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 September 28, 2022,
Scottsdale Research Institute, 12815
North Cave Creek Road, Phoenix,
Arizona 85022, applied to be registered
as a bulk manufacturer of the following
basic class(es) of controlled
substance(s):
DEPARTMENT OF JUSTICE
ACTION:
Notice of application.
VHG Labs dba LGC Standards
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTARY
INFORMATION listed below for further
drug information.
SUMMARY:
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 January 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before January 11, 2023.
DATES:
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. 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on September 12, 2022,
VHG Labs dba LGC Standards, 3
Perimeter Road, Manchester, New
Hampshire 03103–3341, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement Administration
[Docket No. DEA–1114]
Importer of Controlled Substances
Application: VHG Labs dba LGC
Standards
Drug Enforcement
Administration, Justice.
AGENCY:
Controlled substance
Drug code
Cathinone ........................................................................................................................................................................
Methcathinone .................................................................................................................................................................
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76085
Federal Register / Vol. 87, No. 237 / Monday, December 12, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Mephedrone (4-Methyl-N-methylcathinone) ....................................................................................................................
Naphyrone .......................................................................................................................................................................
N-Ethylamphetamine .......................................................................................................................................................
Gamma Hydroxybutyric Acid ...........................................................................................................................................
Methaqualone ..................................................................................................................................................................
JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ..................................................................................................
SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ................................................
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ..............................................................
JWH–081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) ..................................................................................................
SR–19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole ....................................................................
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ..............................................................................
JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) .....................................................................................................
UR–144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................
JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) ......................................................................................................
Ibogaine ...........................................................................................................................................................................
Lysergic acid diethylamide ..............................................................................................................................................
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Mescaline .........................................................................................................................................................................
2,5-Dimethoxyamphetamine ............................................................................................................................................
JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) ......................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
4-Methoxyamphetamine ..................................................................................................................................................
5-Methoxy-N-N-dimethyltryptamine .................................................................................................................................
Bufotenine ........................................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
4-Methyl-alphapyrrolidinopropiophenone (4-MePPP) .....................................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) .......................................................................................................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ......................................................................................................
Butylone ...........................................................................................................................................................................
Pentylone .........................................................................................................................................................................
Codeine-N-oxide ..............................................................................................................................................................
Desomorphine .................................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Heroin ..............................................................................................................................................................................
Morphine-N-oxide ............................................................................................................................................................
Normorphine ....................................................................................................................................................................
Pholcodine .......................................................................................................................................................................
Alphamethadol .................................................................................................................................................................
Norlevorphano .................................................................................................................................................................
Properidine ......................................................................................................................................................................
Tilidine .............................................................................................................................................................................
Alpha-methylfentanyl .......................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ...............................................................................
Butyryl Fentany ................................................................................................................................................................
Fentanyl-related substance .............................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Phenmetrazine .................................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Glutethimide .....................................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Norfentanyl ......................................................................................................................................................................
Phenylacetone .................................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Diphenoxylate ..................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Isomethadone ..................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Meperidine intermediate-A ..............................................................................................................................................
Meperidine intermediate-B ..............................................................................................................................................
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1475
2010
2565
6250
7008
7048
7081
7104
7118
7122
7144
7203
7260
7315
7350
7360
7370
7381
7396
7398
7405
7411
7431
7433
7437
7438
7498
7535
7540
7541
7542
9053
9055
9145
9200
9307
9313
9314
9605
9634
9644
9750
9814
9821
9822
9850
1100
1105
1631
1724
2125
2270
2315
2550
7471
8333
8366
8501
9041
9050
9120
9143
9150
9170
9180
9190
9193
9220
9226
9230
9232
9233
Schedule
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76086
Federal Register / Vol. 87, No. 237 / Monday, December 12, 2022 / Notices
Controlled substance
Drug code
Meperidine intermediate-C ..............................................................................................................................................
Methadone .......................................................................................................................................................................
Methadone intermediate ..................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
14-Hydroxmorphone ........................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Phenazocine ....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis. In reference to drug codes 7360
(Marihuana) and 7370
(Tetrahydrocannabinols) the company
plans to import a synthetic cannabidiol
and a synthetic tetrahydrocannabinol.
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
import of Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–26925 Filed 12–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1113]
Importer of Controlled Substances
Application: Lyndra Therapeutics
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
18:08 Dec 09, 2022
Jkt 259001
In
accordance with 21 CFR 1301.34(a), this
is notice that on October 14, 2022,
Lyndra Therapeutics, 60 Westview
Street, Lexington, Massachusetts 02421–
3108, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Lyndra Therapeutics has
applied to be registered as an importer
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 January 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before January 11, 2023.
SUMMARY:
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. 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.
ADDRESSES:
Controlled substance
Methadone .....................
Drug
code
9250
Schedule
II
The company plans to import the
above controlled substance for use in
preclinical research and human clinical
trials. No other activity for this drug
code is authorized for this registration.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
9234
9250
9254
9273
9300
9333
9652
9665
9668
9715
9740
9743
9801
Schedule
II
II
II
II
II
II
II
II
II
II
II
II
II
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
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022–26920 Filed 12–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On December 6, 2022, the Department
of Justice lodged a proposed consent
decree with the United States District
Court for the District of Puerto Rico in
the lawsuit entitled United States v.
Puerto Rico Industrial Development
Company, Civil Action No. 3:15–cv–
2328.
In that action, the United States
sought, pursuant to the Comprehensive
Environmental Response,
Compensation, and Liability Act
(‘‘CERCLA’’), 42 U.S.C. 9601, et seq.,
recovery of response costs regarding the
Maunabo Groundwater Superfund Site
in Maunabo, Puerto Rico (the ‘‘Site’’).
The proposed consent decree will
require the Puerto Rico Industrial
Development Company to reimburse the
U.S. Environmental Protection Agency
for $11 million of its past costs at the
Site. The reimbursements are to be
made in quarterly installments over
seven years, with interest.
The publication of this notice opens
a period for public comment on the
proposed consent decree. Comments
should be addressed to the Assistant
Attorney General, Environment and
E:\FR\FM\12DEN1.SGM
12DEN1
]]>Agencies
[Federal Register Volume 87, Number 237 (Monday, December 12, 2022)]
[Notices]
[Pages 76084-76086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26925]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1114]
Importer of Controlled Substances Application: VHG Labs dba LGC
Standards
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: VHG Labs dba LGC Standards has applied to be registered as an
importer 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
January 11, 2023. Such persons may also file a written request for a
hearing on the application on or before January 11, 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. 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 September 12, 2022, VHG Labs dba LGC Standards, 3
Perimeter Road, Manchester, New Hampshire 03103-3341, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone........................... 1235 I
Methcathinone....................... 1237 I
[[Page 76085]]
Mephedrone (4-Methyl-N- 1248 I
methylcathinone).
Naphyrone........................... 1258 I
N-Ethylamphetamine.................. 1475 I
Gamma Hydroxybutyric Acid........... 2010 I
Methaqualone........................ 2565 I
JWH-250 (1-Pentyl-3-(2- 6250 I
methoxyphenylacetyl) indole).
SR-18 (Also known as RCS-8) (1- 7008 I
Cyclohexylethyl-3-(2-
methoxyphenylacetyl) indole).
APINACA and AKB48 N-(1-Adamantyl)-1- 7048 I
pentyl-1H-indazole-3-carboxamide.
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
SR-19 (Also known as RCS-4) (1- 7104 I
Pentyl-3-[(4-methoxy)-benzoyl]
indole.
JWH-018 (also known as AM678) (1- 7118 I
Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I
naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3- 7144 I
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone.
JWH-203 (1-Pentyl-3-(2- 7203 I
chlorophenylacetyl) indole).
Ibogaine............................ 7260 I
Lysergic acid diethylamide.......... 7315 I
Marihuana Extract................... 7350 I
Marihuana........................... 7360 I
Tetrahydrocannabinols............... 7370 I
Mescaline........................... 7381 I
2,5-Dimethoxyamphetamine............ 7396 I
JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I
naphthoyl) indole).
3,4-Methylenedioxymethamphetamine... 7405 I
4-Methoxyamphetamine................ 7411 I
5-Methoxy-N-N-dimethyltryptamine.... 7431 I
Bufotenine.......................... 7433 I
Psilocybin.......................... 7437 I
Psilocyn............................ 7438 I
4-Methyl- 7498 I
alphapyrrolidinopropiophenone (4-
MePPP).
MDPV (3,4- 7535 I
Methylenedioxypyrovalerone).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone............................ 7541 I
Pentylone........................... 7542 I
Codeine-N-oxide..................... 9053 I
Desomorphine........................ 9055 I
Dihydromorphine..................... 9145 I
Heroin.............................. 9200 I
Morphine-N-oxide.................... 9307 I
Normorphine......................... 9313 I
Pholcodine.......................... 9314 I
Alphamethadol....................... 9605 I
Norlevorphano....................... 9634 I
Properidine......................... 9644 I
Tilidine............................ 9750 I
Alpha-methylfentanyl................ 9814 I
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentany..................... 9822 I
Fentanyl-related substance.......... 9850 I
Amphetamine......................... 1100 II
Methamphetamine..................... 1105 II
Phenmetrazine....................... 1631 II
Methylphenidate..................... 1724 II
Amobarbital......................... 2125 II
Pentobarbital....................... 2270 II
Secobarbital........................ 2315 II
Glutethimide........................ 2550 II
Phencyclidine....................... 7471 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Norfentanyl......................... 8366 II
Phenylacetone....................... 8501 II
Cocaine............................. 9041 II
Codeine............................. 9050 II
Dihydrocodeine...................... 9120 II
Oxycodone........................... 9143 II
Hydromorphone....................... 9150 II
Diphenoxylate....................... 9170 II
Ecgonine............................ 9180 II
Ethylmorphine....................... 9190 II
Hydrocodone......................... 9193 II
Levorphanol......................... 9220 II
Isomethadone........................ 9226 II
Meperidine.......................... 9230 II
Meperidine intermediate-A........... 9232 II
Meperidine intermediate-B........... 9233 II
[[Page 76086]]
Meperidine intermediate-C........... 9234 II
Methadone........................... 9250 II
Methadone intermediate.............. 9254 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
Morphine............................ 9300 II
Thebaine............................ 9333 II
Oxymorphone......................... 9652 II
14-Hydroxmorphone................... 9665 II
Noroxymorphone...................... 9668 II
Phenazocine......................... 9715 II
Sufentanil.......................... 9740 II
Carfentanil......................... 9743 II
Fentanyl............................ 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
sale to research facilities for drug testing and analysis. In reference
to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols) the
company plans to import a synthetic cannabidiol and a synthetic
tetrahydrocannabinol. 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 import
of Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2022-26925 Filed 12-9-22; 8:45 am]
BILLING CODE P
