Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024, 102638-102649 [2024-30019]
Download as PDF
<![CDATA[
102638
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1228F]
Final Adjusted Aggregate Production
Quotas for Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2024
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
This final order establishes
the final adjusted 2024 aggregate
production quotas for controlled
substances in schedules I and II of the
Controlled Substances Act and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
This order is effective December
17, 2024.
FOR FURTHER INFORMATION CONTACT:
Heather E. Achbach, Regulatory Drafting
and Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, VA
22152, Telephone: (571) 362–3261.
SUPPLEMENTARY INFORMATION:
DATES:
Legal Authority
Section 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to
establish production quotas for each
basic class of controlled substances
listed in schedules I and II and for
ephedrine, pseudoephedrine, and
phenylpropanolamine. The Attorney
General has delegated this function to
the Administrator of the Drug
Enforcement Administration (DEA)
pursuant to 28 CFR 0.100.
ddrumheller on DSK120RN23PROD with NOTICES2
DEA published the 2024 established
aggregate production quotas (APQs) for
controlled substances in schedules I and
II and for the assessment of annual
needs (AAN) for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine in the Federal
Register (FR) on January 3, 2024.1 This
notice stated that the Administrator
would adjust, as needed, the established
APQ in 2024 in accordance with 21 CFR
1303.13 and 21 CFR 1315.13. DEA is
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
Comments Received
DEA received 20 timely comments in
response to the September Federal
Register notice, from chronic pain
patients and DEA-registered entities.
The comments included requests to
ensure sufficient availability in the APQ
for select schedule I and schedule II
controlled substances including
increasing specific APQs if necessary;
requests that DEA utilize its regulatory
authority in additional ways; opioid
shortage concerns; and comments
outside the scope of this final order.
DEA restricted three comments from
public view due to confidential business
information and/or confidential
personal identifying information.
DEA’s Regulatory Authority
Background
1 Established Aggregate Production Quotas for
Schedule I and II Controlled Substances and
Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2024, 89 FR 407.
committed to preventing and limiting
diversion by enforcing laws and
regulations regarding controlled
substances and the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, while meeting
the legitimate medical, scientific, and
export needs of the United States.
The 2024 proposed adjusted APQ for
controlled substances in schedules I and
II and AAN for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine were
subsequently published in the Federal
Register on September 25, 2024 2 after
consideration of the criteria outlined in
that notice. All interested persons were
invited to comment on or object to the
proposed APQs and AANs on or before
October 25, 2024. Prior to this notice,
DEA also published a final order to
increase the 2024 APQ for
lisdexamfetamine and d-amphetamine
(for conversion).3 Therefore, DEA
proposed no additional changes for
those substances.
Issue: DEA-registered manufacturers
requested the APQs for 4-Anilino-NPhenethyl-4-Piperidine, fentanyl,
hydromorphone, morphine (for
conversion), oxymorphone (for
conversion), and sufentanil be reviewed
for sufficiency and adjusted if
necessary.
DEA Response: DEA sets the APQs in
a manner to meet the estimated medical,
scientific, research, industrial needs of
the United States, lawful export
requirements, and for the establishment
2 Proposed Adjustments to the Aggregate
Production Quotas for Schedule I and II Controlled
Substances and Assessment of Annual Needs for
the List I Chemicals Ephedrine, Pseudoephedrine,
and Phenylpropanolamine for 2024, 89 FR 78764
(September 25, 2024).
3 Adjustment to the Aggregate Production Quota
for Lisdexamfetamine and d-Amphetamine (for
Conversion) for 2024, 89 FR 72424 (Sept. 5, 2024).
PO 00000
Frm 00002
Fmt 4701
Sfmt 4703
and maintenance of reserve stocks. As of
the date the comment period closed for
the proposed adjusted 2024 APQ and
AAN, DEA believes that the proposed
adjusted 2024 APQs are sufficient to
meet the current estimated 2024
legitimate medical, scientific, research,
and industrial needs of the United
States, for lawful export requirements,
and to provide for adequate reserve
stock.
Issue: A DEA-registered manufacturer
suggested several changes that it
believes are necessary to deter
companies from using the quota process
to gain competitive advantage and to
ensure that quota is available when
supply chain circumstances change.
Among these, the commenter suggested
that DEA needs to obtain authority to
reallocate manufacturing quota from one
registered bulk manufacturer to another
in the event that a finished dosage form
manufacturer wishes, midyear, to
procure bulk material from a different
bulk manufacturer than originally
planned.
DEA Response: This comment is
outside the scope of the current action,
but DEA notes the commenter’s
suggestion for future consideration. DEA
currently can reallocate or revoke quotas
in specific circumstances as discussed
in 21 CFR 1303.26 and 1303.36.
Issue: The same commenter who
raised the immediately preceding issue
also suggested that DEA should change
the procurement quota application form
(DEA Form 250) so that applicants can
specify multiple suppliers from which
they may procure a basic class of bulk
controlled substance, as well as the
estimated timeframe for receipt of the
basic class from each supplier.
DEA Response: The current
procurement quota application form
(DEA Form 250) allows for the
applicants to specify multiple suppliers
from which they may procure a basic
class of bulk controlled substance, as
well as the estimated timeframe for
receipt of the basic class from each
supplier.
Issue: The same commenter who
raised the two immediately preceding
issues suggested that DEA specify, when
granting quota, to which specific
finished dosage forms the quota is to be
applied and the proportion of the
authorized amount that is to be used
toward each identified dosage form. The
manufacturer further requested that
DEA verify during DEA inspections the
manufacturer’s compliance with the
details specified in the quota grant.
DEA Response: In 21 U.S.C. 826(a)(2),
Congress granted DEA the authority to
delineate quota by pharmaceutical
dosage form (tablets, capsules, oral
E:\FR\FM\17DEN2.SGM
17DEN2
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES2
liquids, etc.) if DEA determines it will
assist in avoiding overproduction,
shortages, or diversion of a controlled
substance. DEA currently believes the
designation of quota by dosage forms at
the bulk manufacturing level could lead
to unforeseen circumstances such as
interference with production schedules
or hindrance of the supply chain.
Moreover, in compliance with
Congress’s directive, DEA would need
to consider whether the application of
such detail to quotas would assist in
avoiding overproduction, shortages, or
diversion.
When a manufacturer has several
customers that use the same active
pharmaceutical ingredient (API) to
manufacture similar dosage forms (i.e.
brand and generic formulations), the
terms of the contractual agreements
govern the transaction in normal
circumstances. DEA does not grant
quota to fulfill specific business
contracts between registrants; rather,
DEA grants quota to meet the legitimate
medical, scientific, research, and export
requirements while ensuring the ability
to maintain adequate reserve stock.
Issue: The same commenter who
raised the three immediately preceding
issues suggested that DEA assess ‘‘quota
usage’’ on a quarterly or semi-annual
basis to verify that manufacturers timely
distribute materials that they are
authorized under quota to manufacture,
and to require companies to surrender
unused quotas so that those unused
amounts can be reassigned to others
who can then supply the market.
DEA Response: DEA has in the past
and will continue to ask manufacturers
to surrender quota that they will not be
able to utilize in a timely manner (e.g.,
due to production scheduling issues,
malfunctioning of manufacturing lines,
etc.). While DEA will note for potential
future consideration the commenter’s
suggestion that DEA periodically assess
quota usage, in a series of meetings held
in the spring of 2024, numerous API and
dosage form manufacturers informed
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
DEA that a requirement to utilize quota
quarterly would not be feasible because
of limited capacity of production lines
and manufacturers’ strict adherence to
production schedules. As a result of the
discussion, DEA is allotting commercial
manufacturing procurement quotas for
Schedule II non-injectable products on
a semi-annual basis.
Opioid Shortage Concerns
Issue: Nine commenters expressed
general concerns regarding a perceived
nationwide shortage of opioid
medication due to patients experiencing
intermittent out-of-stock or backordered situations at pharmacies while
attempting to fill their prescriptions.
DEA Response: DEA utilizes the
available, reliable data and information
received by the agency in advance of
publication; however drug shortages
may occur due to factors outside of
DEA’s control such as manufacturing
and quality problems, processing
delays, supply chain disruptions, or
discontinuations. In such
circumstances, if the drug manufacturer
notifies the U.S. Food and Drug
Administration (FDA) Drug Shortage
Staff, FDA will coordinate with DEA to
address and minimize the impact of
drug shortages if both agencies believe
action is warranted. Currently, FDA has
not issued notice of any nationwide
shortages of the type of opioid
medications mentioned by these
commenters.
Out of Scope Comments: DEA
received other comments that were
general in nature and raised issues with
respect to specific medical illnesses and
medical treatments. All of the issues
raised are outside of the scope of this
final order for 2024 and do not impact
the analysis involved in finalizing the
2024 APQs.
Analysis for Final Adjusted 2024
Aggregate Production Quotas and
Assessment of Annual Needs
In determining the final adjusted 2024
APQs and AANs, DEA has considered
PO 00000
Frm 00003
Fmt 4701
Sfmt 4703
102639
the above comments relevant to this
final order for calendar year 2024, along
with the factors set forth in 21 CFR
1303.13 and 21 CFR 1315.13, in
accordance with 21 U.S.C. 826(a). DEA
has also considered other relevant
factors, including the 2023 year-end
inventories, initial 2024 manufacturing
and import quotas, 2024 export
requirements, actual and projected 2024
sales, research and product
development requirements, additional
applications received, and the extent of
any diversion of the controlled
substance in the class. Based on all of
the above, the Administrator is
finalizing the adjusted APQs in the
same amounts as proposed.
On July 29, 2024, DEA published a
temporary scheduling order placing Ndesethyl isotonitazene and Npiperidinyl etonitazene in schedule I of
the CSA, 4 and on October 25, 2024,
DEA published a final rule placing
ethylphenidate in schedule I of the
CSA, 5 making all regulatory controls
pertaining to schedule I controlled
substances applicable to the
manufacture of these substances,
including the requirement to establish
an APQ pursuant to 21 U.S.C. 826 and
21 CFR part 1303. This final order
establishes an APQ for these substances
for the first time.
Pursuant to the above, the
Administrator hereby finalizes the 2024
APQs for the following schedule I and
II controlled substances and the 2024
AANs for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
BILLING CODE 4410–P
4 Schedules of Controlled Substances: Temporary
Placement of N-Desethyl Isotonitazene and NPiperidinyl Etonitazene in Schedule I, 89 FR 60817.
5 Schedules of Controlled Substances: Placement
of Ethylphenidate in Schedule I, 89 FR 84281.
E:\FR\FM\17DEN2.SGM
17DEN2
102640
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Final Adjusted
2024 Quotas
Basic Class
(2)
-[ 1-(2-Thienyl)cyclohexy l]pyrrolidine
1-( 1-Phenylcyclohexyl)pyrrolidine
1-(2-Phenylethy 1)-4-pheny1-4-acetoxypiperidine
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
1-[ 1-(2-Thieny I)cyclohexy l]piperidine
2'-fluoro 2-fluorofentanyl
1-Benzylpiperazine
1-Methy1-4-phenyl-4-propionoxypiperidine
2-(2,5-D imethoxy-4-ethy lphenyl)ethanamine (2C-E)
2-(2,5-Dimcthoxy-4-mcthylphcnyl)cthanaminc (2CD)
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2CP)
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25B-NBOMe; 2C-BNBOMe; 25B; Cimbi-36)
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25C-NBOMe; 2C-CNBOMe; 25C; Cimhi-82)
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (251-NBOMe; 2C-INBOMe; 251; Cimbi-5)
2,5-Dimethoxy-4-ethylamphetamine (DOET)
2,5-Dimcthoxy-4-n-propylthiophcncthylaminc
2,5-Dimethoxyamphetamine
2-[4-(Ethylthio )-2,5-dimethoxyphenyl]ethanamine
(2C-T-2)
2-[4-(Isopropylthio )-2,5dimethoxypheny l]ethanamine (2C-T-4)
2-Methyl AP-237
3,4,5-Trimethoxyamphetamine
3,4-Methylenedioxyamphetamine (MDA)
3,4-Methy lenedioxymethamphetamine (MD MA)
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
3,4-Methylenedioxy-N-methylcathinone (methylone)
3,4-Methy lenedioxypyrovalerone (MDPV)
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00004
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
20
30
10
30
30
15
30
25
10
30
30
30
30
100
30
30
25
30
30
25
25
25
30
30
30
30
12,000
12,000
40
5,200
35
17DEN2
EN17DE24.086</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
Schedule I
3-FMC; 3-Fluoro-N-methylcathinone
3-Methylfentanyl
3-Methylmethcathinone
3-Methylthiofentanyl
4,4'-Dimethylaminorex
4-Bromo-2,5-dimethoxyamphetamine (DOB)
4-Bromo-2,5-dimelhoxyphenelhy lamine (2-CB)
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloroalpha-PVP)
4-CN-Cumyl-Butinaca
4-Fluoroisobutyryl fentanyl
4F-MDMB-BINACA
4F-MDMB-BUTTCA
4-PMC; Plephedrone
4-MEC; 4-Melhyl-N-ethylcalhinone
4-Methoxyamphetamine
4-methyl-l-phenyl-2-(pyrrolidin-l-yl)pentan-l-one
(alpha-PiHP)
4-Methyl-2,5-dimethoxyamphetamine (DOM)
4-Methylaminorex
4-Methyl-N-methylcathinone (mephedrone)
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)
4'-Methyl acetyl fentanyl
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP)
5-(1, 1-Dimethylheptyl)-2-[(lR,3S)-3hvdroxvcvclohexvll-ohenol
5-( 1, l-Dimethyloctyl)-2-[(lR,3S)-3hydroxycyclohexyl]-phenol (cannabicyclohexanol or
CP-47.497 C8-homolog)
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2yl)-1-(5-fluoropentyl)-lH-indazole-3-carboxamide
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5fluoropentyl)-1 H-indazole-3-carboxamido)-3,3dimethvlbutanoate)
5P-CUMYL-P7AICA; 1-(5-Pluoropentyl)-N-(2phenylpropan-2-yl)-1H-pyrrolo[2,3-b ]pyridine3carboximide
5F-CUMYL-PINACA
5F-EDMB-PICA
5F-EDMB-PINACA
5F-MDMB-PICA
5F-AMB (methyl 2-(1-(5-fluoropentyl)-lH-indazole3-carboxamido)-3-methvlbutanoate)
5F-APINACA; 5F-AKB48 (N-(adamantan-l-yl)-1-(5fluoropentyl)-1 H-indazole-3-carboxamide)
5-Fluoro-PB-22; 5F-PB-22
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00005
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
102641
25
30
30
30
30
30
5,100
25
25
30
30
30
25
25
150
30
25
25
45
25
25
30
25
50
40
25
25
25
25
30
25
r_:,
r_:,
r_:,
25
17DEN2
EN17DE24.087</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
5-Fluoro-UR144, XLRl l ([1-(5-fluoro-pentyl)11Iindol-3-yl](2,2,3,3tetramethy lcyclopropyl)methanone
5-Methoxy-3 ,4-methylenedioxyamphetamine
5-Methoxy-N,N-diisopropyltryptamine
5-Methoxy-N,N-dimethyltryptamine
AB-CHMINACA
AB-FUBTNACA
AB-PINACA
ADB-4en-PINACA
ADB-BUTINACA
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-(4-fluorobenzyl)-lH-indazole-3carboxan1ide)
Acetorphine
Acetyl Fentanyl
Acetyl-alpha-methy lfentanyl
Acetyldihydrocodeine
Acctylmcthadol
Acryl Fentanyl
ADB-PINACA (N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-l-pentyl-1 H-indazole-3-carboxamide)
AH-7921
All other tetrahydrocannabinol
Allylprodine
Alphacctylmcthadol
alpha-Ethyltryptamine
Alphameprodine
Alphamethadol
alpha-Methylfentanyl
alpha-Methylthiofentanyl
alpha-Methyltryptamine (AMT)
alpha-Pyrrolidinobutiophcnonc (a-PBP)
alpha-pyrrolidinoheptaphenone (PV8)
alpha-pyrrolidinohexabophenone (alpha-PHP)
alpha-Pyrrolidinopentiophenone (a-PVP)
Amineptine
Aminorex
Anileridine
APINCA, AKB48 (N-(l-adamantyl)-1-pentyl-lIIindazole-3-carboxamide)
Bcnzcthidinc
Benzy!morphine
Betacetylmethadol
beta-Hydroxy-3-methylfentanyl
beta-Hydroxyfentanyl
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00006
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
25
25
25
11,000
30
50
30
30
30
30
25
100
30
30
25
25
50
30
1,166,130
25
25
25
25
25
30
30
25
25
25
25
25
30
25
20
25
25
30
25
30
30
17DEN2
EN17DE24.088</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
102642
beta-Hydroxythiofentanyl
beta-Methyl fentanyl
beta'-Phenyl fentanyl
Betameprodine
Bctamcthadol
Betaprodine
Brorphine
Bufotenine
Butonitazene
Butylone
Butyryl fentanyl
Cathinone
Clonazolam
Clonitazene
Codeine methylbromide
Codeine-N-oxide
Crotonyl Fentanyl
CUMYL-PEGACLONE
Cyclopentyl Fentanyl
Cyclopropyl Fentanyl
Cyprenorphine
d-9-THC
Desomorphine
Dextromoramide
Diapromide
Diclazepam
Diethylthiambutene
Diethy ltryptamine
Difcnoxin
Dihydromorphine
Dimenoxadol
Dimepheptanol
Dimethylthiambutene
Dimethyltryptamine
Dioxyaphetyl butyrate
Dipipanonc
Drotebanol
Ethylmethylthiambutene
Ethylone
Ethylphenidale
Etizolam
Etodesnitazene
Etonitazene
Etorphine
Etoxeridine
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00007
102643
30
30
30
25
4
25
30
15
30
25
30
40
30
25
30
192
25
30
30
20
25
1,523,040
25
25
20
30
20
25
9,300
639,954
25
25
20
11,000
25
25
25
25
25
30
30
30
25
30
25
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
17DEN2
EN17DE24.089</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Eutylone
Fenethylline
Fentanyl carbamate
Fentanyl related substances
Flualprazolam
Flubromazolam
Flunitazene
FUB-144
30
30
30
600
30
30
30
25
25
ddrumheller on DSK120RN23PROD with NOTICES2
FUB-AKB48
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca
Furanyl fentanyl
Furethidine
gamma-Hydroxybutyric acid
Heroin
Hydromorphinol
Hydroxypethidine
Ibogaine
Isobutyryl Fentanyl
lsotonitazine
JWH-018 and AM678 (l-Pentyl-3-(1naphthoy1)indole)
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
JWH-073 (l-Butyl-3-(1-naphthoyl)indole)
JWH-081 (1-Pentyl-3-[l-(4methoxynaphthoy I) lindole)
JWH-122 (1-Pentyl-3-( 4-methyl-1-naphthoyl)indole)
.IWH-200 (1-l2-(4-Morpholinyl)ethylj-3-(lnaohthov l)indole)
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
JWH-250 (1-Pentyl-3-(2methoxypheny lacetyl)indole)
JWH-398 (1-Pentyl-3-( 4-chloro-1-naphthoyl)indole)
Ketobemidone
Levomoramide
T.evophenyacylmorphan
Lysergic acid diethylamide (LSD)
MAB-CHMINACA; ADB-CHMINACA (N-(1aniino-3 ,3-dimethyl-1-oxobutan-2-yl)-1(cvclohexv lmethv l)-1 H-indazole-3-carboxamide)
MDMB-4en-PINACA
MDMB-CHMTCJ\; MMB-CHMTNJ\CJ\(methyl 2-(1(cyclohexylmethyl)- lH-indole-3-carboxamido )-3,3dimcthv lbutanoatc)
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)1H-indazole-3-carboxan1ido)-3,3-dimethylbutanoate)
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1(cvclohexvlmethyl)- lH-indole-3-carboxamido )-3-
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00008
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
25
30
25
29,417,000
150
40
25
150
25
25
35
45
45
30
30
35
30
30
30
30
25
25
1,200
30
30
30
30
25
17DEN2
EN17DE24.090</GPH>
102644
methy lbutanoate
MMB-FUBICA
Marijuana
Marijuana extract
Mecloqualone
Mescaline
Mesocarb
Methaqualone
Methcathinone
Methiopropamine
Methoxetamine
MethoxyacetyI fentany I
Methyldesorphine
Methyldihydromorphine
Metodesnitazene
Metonitazene
Morpheridine
Morphine methylbromide
Morphine methylsulfonate
Morphine-N-oxide
MT-45
Myrophine
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-lHindole-3-carboxylate
N,N-Dimethylamphetamine
Naphyronc
N-Ethyl-1-phenylcyclohexylamine
N-Ethyl-3-piperidyl benzilate
N-Ethylamphetamine
N-Ethylhexedrone
N-Ethylpentylone, ephylone
N-Hydroxy-3,4-methylenedioxyamphetamine
Nicocodeine
Nicomorphine
N-Desethyl Isotonitazene
N-methyl-3-piperidyl benzilate
N-PiperidinyI Etonitazene
N-Pyrrolidino Etonitazene
Noracymcthadol
Norlevorphanol
Normethadone
Normorphine
Norpipanone
Ocfentanil
ortho-Fluoroacryl fentanyl
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00009
Fmt 4701
Sfmt 4725
E:\FR\FM\17DEN2.SGM
102645
30
6,675,000
1,000,000
30
1,200
30
60
25
30
30
30
5
25
30
30
25
5
5
150
30
25
25
25
25
25
10
24
25
30
24
25
25
30
30
30
30
25
2,550
25
40
25
25
30
17DEN2
EN17DE24.091</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
ortho-Fluoro butyry l fentany l
ortho-Pluorofentany1,2-Pluorofentany1
ortho-Fluoroisobutyryl fentanyl
ortho-Methyl acetylfentanyl
ortho-Methyl methoxyacetyl fentanyl
Para-Chloriso butyrl fentany 1
Para-flourobutyryl fentanyl
Para-fl uorofentanyl
para-Fluoro furanyl fentanyl
Para-Methoxybutyrl fentanyl
Para-methoxymethamphetamine
para-Methy lfentany1
Parahexyl
PB-22; QUPIC
Pentedrone
Pentylone
Phenadoxone
Phenampromide
Phenomorphan
Phenoperidine
Phenyl fentanyl
Pholcodine
Piritran1ide
Proheptazine
Properidine
Propiram
Protonitazene
Psilocybin
Psilocyn
Racemoran1ide
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2methoxypheny lacety1)indole)
SR-19 and RCS-4 (l-Pentyl-3-[(4-methoxy)benzoy1lindole)
Tetrahydrofuranyl fentanyl
Thebacon
Thiafentanil
Thiofcntanyl
Thiofuranyl frntanyl
THJ-2201 ( [1-(5-fluoropentyl)-IH-indazol-3yll(naphthalen-1-yl)methanone)
Tilidine
Trimeperidine
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3tetramethy lcyclopropyl)methanone
U-47700
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00010
Fmt 4701
Sfmt 4725
30
30
30
30
30
30
25
25
30
30
30
30
5
20
25
25
25
25
25
25
30
5
25
25
25
25
30
30,000
36,000
25
45
30
15
25
25
25
30
30
25
25
25
30
E:\FR\FM\17DEN2.SGM
17DEN2
EN17DE24.092</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
102646
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Valeryl fentanyl
Zipeprol
102647
25
30
1-Phenylcyclohexylamine
1-P iperidinocyclohexanecarbonitrile
4-Anilino-N-phenethyl-4-piperidine (ANPP)
Alfentanil
Alphaprodine
Amo barbital
Beziiramide
Carfentanil
Cocaine
Codeine (for conversion)
Codeine (for sale)
cl-amphetamine (for sale)
d,1-amphetamine
cl-amphetamine (for conversion)
Dexmethylphenidate (for sale)
Dexmethylphenidate (for conversion)
Dextropropoxyphene
Dihydrocodeine
Dihydroctorphinc
Diphenoxylate (for conversion)
Diphenoxylate (for sale)
Ecgonine
Ethylmorphine
Etorphine hydrochloride
Fentanyl
Glutethimide
Hydrocodone (for conversion)
Hydrocodone (for sale)
Hydromorphone
Isomethadone
L-amphetamine
Levo-alphacetylmethadol (LAAM)
Levomethorphan
Levorphanol
Lisdexamfetamine
Meperidine
Meperidine Intermediate-A
Meperidine Intermediate-B
Meperidine lntermediate-C
Metazocine
Methadone (for sale)
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
PO 00000
Frm 00011
Fmt 4701
Sfmt 4725
15
25
937,874
5,000
25
20,100
25
20
60,492
942,452
19,262,957
21,200,000
21,200,000
23,688,235
6,200,000
5,374,683
35
115,227
25
14,100
770,800
60,492
30
32
731,341
25
1,250
27,121,498
1,951,508
30
30
25
30
20,000
32,736,000
681,184
30
30
30
15
25,619,700
E:\FR\FM\17DEN2.SGM
17DEN2
EN17DE24.093</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
Schedule II
102648
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
Methadone Intermediate
d,1-Methamphetamine
d-methamphetamine (for conversion)
d-methamphetamine (for sale)
1-methamphetamine
Methylphenidate (for sale)
Methylphenidate (for conversion)
Metopon
Moramidc-intcrmcdiatc
Morphine (for conversion)
Morphine (for sale)
Nabilone
Norfentanyl
Noroxymorphone (for conversion)
Noroxymorphone (for sale)
Oliceridine
Opium (powder)
Opiwn (tincture)
Oripavine
Oxycodonc (for conversion)
Oxycodone (for sale)
Oxymorphone (for conversion)
Oxymorphone (for sale)
Pentobarbital
Phenazocine
Phencyclidine
Phenmetrazine
Phenylacetone
Piminodine
Racemethorphan
Racemorphan
Remifentanil
Secobarbital
Sufentanil
Tapentadol
Thebaine
27,673,600
150
485,020
47,000
587,229
53,283,000
19,975,468
25
25
2,393,200
20,805,957
62,000
25
24,756,979
1,000
25,100
250,000
530,837
37,721,950
437,827
53,584,449
31,773,105
464,464
40,000,000
25
35
25
100
25
5
5
3,000
172,100
4,000
10,390,226
57,137,944
Ephedrine (for conversion)
Ephedrine (for sale)
Phenylpropanolamine (for conversion)
Phenylpropanolamine (for sale)
Pseudoephedrine (for conversion)
Pseudoephedrine (for sale)
BILLING CODE 4410–C
VerDate Sep<11>2014
23:08 Dec 16, 2024
41,100
3,933,336
14,878,320
7,990,000
1,000
186,617,466
The Administrator also establishes
that APQs for all other schedule I and
Jkt 265001
PO 00000
Frm 00012
Fmt 4701
Sfmt 4703
II controlled substances included in 21
E:\FR\FM\17DEN2.SGM
17DEN2
EN17DE24.094</GPH>
ddrumheller on DSK120RN23PROD with NOTICES2
List I Chemicals
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
CFR 1308.11 and 1308.12 remain at
zero.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on December 13, 2024, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2024–30019 Filed 12–16–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1413E]
Established Aggregate Production
Quotas for Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2025
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
This final order establishes
the initial 2025 aggregate production
quotas for controlled substances in
schedules I and II of the Controlled
Substances Act and the assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: This order is effective December
17, 2024.
FOR FURTHER INFORMATION CONTACT:
Heather E. Achbach, Regulatory Drafting
and Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, VA
22152, Telephone: (571) 776–3882.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES2
SUMMARY:
I. Legal Authority
Section 306 of the Controlled
Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to
establish production quotas for each
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
basic class of controlled substance listed
in schedule I and II and ephedrine,
pseudoephedrine, and
phenylpropanolamine. The Attorney
General has delegated this function to
the Administrator of the Drug
Enforcement Administration (DEA)
pursuant to 28 CFR 0.100.
II. Background
The 2025 aggregate production quotas
(APQ) and assessment of annual needs
(AAN) represent those quantities of
schedule I and II controlled substances
and the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine that may be
manufactured in the United States in
2025, in order to provide for the
estimated medical, scientific, research,
and industrial needs of the U.S., lawful
export requirements, and the
establishment and maintenance of
reserve stocks. These quotas include
imports of ephedrine, pseudoephedrine,
and phenylpropanolamine, but do not
include imports of controlled
substances for use in industrial
processes.
On September 25, 2024, a notice titled
‘‘Proposed Aggregate Production Quotas
for Schedule I and II Controlled
Substances and Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2025’’ was
published in the Federal Register.1 This
notice proposed the 2025 APQs for each
basic class of controlled substance listed
in schedules I and II and the 2025 AANs
for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. All interested
persons were invited to comment on or
object to the proposed APQs and the
proposed AANs on or before October 25,
2024.
III. Comments Received
Within the public comment period,
DEA received 1,882 comments from
DEA registrants, chronic pain patients,
patients with attention deficit/
hyperactivity disorder (ADHD), pain
advocacy associations, U.S. professional
associations, U.S. doctors and nurses,
and others. The comments included
concerns about potential domestic
opioid drug shortages due to further
quota reductions; patient difficulty
filling authorized opioid prescriptions;
increases in drug overdose deaths
despite a continued decrease in
1 Proposed Aggregate Production Quotas for
Schedule I and II Controlled Substances and
Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2025, 89 FR 78772
(September 25, 2024).
PO 00000
Frm 00013
Fmt 4701
Sfmt 4703
102649
production quotas; requests for an
extension to the comment period;
stimulant drug shortages in the United
States; concerns that medical
professionals might be impeded from
exercising their medical expertise
regarding opioid prescriptions; requests
for a public hearing; and comments not
pertaining to DEA-regulated activities.
While all comments were posted to
regulations.gov, DEA restricted the
attachments to 10 comments from
public view due to confidential business
information and/or confidential
personal identifying information.
Opioid Adequacy
Issue (National Production Levels of
Proposed APQs for Opioids Compared
to 2024 levels): DEA received a
significant number of comments from
pain advocacy groups, hospital
associations, health professionals, and
others who raised concerns over the
proposed APQs for certain opioids in
2025, which were proposed at a level
lower than the established production
levels for 2024. The commenters
suggested that the proposed APQ levels
could exacerbate shortages experienced
in 2024.
DEA Response: DEA considers
numerous factors in determining an
APQ, including total net disposal of the
class by all manufacturers during the
current and two preceding years, trends
in the national rate of net disposal of the
class, total actual or estimated
inventories of the class and of all
substances manufactured from the class,
information obtained from the Food and
Drug Administration (FDA), and
changes in the currently accepted
medical use in treatment. 21 U.S.C.
826(a); 21 CFR 1303.11(b). Additional
factors considered can be found in 21
CFR 1303.11(b). After considering all of
the relevant factors, DEA has
determined that the proposed APQs for
the five covered controlled substances—
fentanyl, hydrocodone, hydromorphone,
oxycodone and oxymorphone—are
sufficient to meet the forecasted
legitimate domestic and foreign needs
and allow for maintenance of reserve
stocks. These considerations also lead
DEA to conclude that U.S.
manufacturers will need to manufacture
approximately the same amount of those
opioids in 2025 as in 2024 in order to
meet legitimate needs.
Accordingly, DEA proposed the 2025
APQs for those five substances at the
same level as in DEA’s proposed revised
APQs for 2024 published on September
E:\FR\FM\17DEN2.SGM
17DEN2
]]>Agencies
[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Notices]
[Pages 102638-102649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30019]
[[Page 102637]]
Vol. 89
Tuesday,
No. 242
December 17, 2024
Part IX
Department of Justice
-----------------------------------------------------------------------
Drug Enforcement Administration
-----------------------------------------------------------------------
Final Adjusted Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024;
Established Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2025;
Notices
Federal Register / Vol. 89 , No. 242 / Tuesday, December 17, 2024 /
Notices
[[Page 102638]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1228F]
Final Adjusted Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: This final order establishes the final adjusted 2024 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: This order is effective December 17, 2024.
FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish production quotas for each
basic class of controlled substances listed in schedules I and II and
for ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney
General has delegated this function to the Administrator of the Drug
Enforcement Administration (DEA) pursuant to 28 CFR 0.100.
Background
DEA published the 2024 established aggregate production quotas
(APQs) for controlled substances in schedules I and II and for the
assessment of annual needs (AAN) for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine in the Federal Register (FR)
on January 3, 2024.\1\ This notice stated that the Administrator would
adjust, as needed, the established APQ in 2024 in accordance with 21
CFR 1303.13 and 21 CFR 1315.13. DEA is committed to preventing and
limiting diversion by enforcing laws and regulations regarding
controlled substances and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, while meeting the legitimate
medical, scientific, and export needs of the United States.
---------------------------------------------------------------------------
\1\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2024, 89 FR 407.
---------------------------------------------------------------------------
The 2024 proposed adjusted APQ for controlled substances in
schedules I and II and AAN for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine were subsequently published in
the Federal Register on September 25, 2024 \2\ after consideration of
the criteria outlined in that notice. All interested persons were
invited to comment on or object to the proposed APQs and AANs on or
before October 25, 2024. Prior to this notice, DEA also published a
final order to increase the 2024 APQ for lisdexamfetamine and d-
amphetamine (for conversion).\3\ Therefore, DEA proposed no additional
changes for those substances.
---------------------------------------------------------------------------
\2\ Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual
Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2024, 89 FR 78764 (September 25, 2024).
\3\ Adjustment to the Aggregate Production Quota for
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR
72424 (Sept. 5, 2024).
---------------------------------------------------------------------------
Comments Received
DEA received 20 timely comments in response to the September
Federal Register notice, from chronic pain patients and DEA-registered
entities. The comments included requests to ensure sufficient
availability in the APQ for select schedule I and schedule II
controlled substances including increasing specific APQs if necessary;
requests that DEA utilize its regulatory authority in additional ways;
opioid shortage concerns; and comments outside the scope of this final
order. DEA restricted three comments from public view due to
confidential business information and/or confidential personal
identifying information.
DEA's Regulatory Authority
Issue: DEA-registered manufacturers requested the APQs for 4-
Anilino-N-Phenethyl-4-Piperidine, fentanyl, hydromorphone, morphine
(for conversion), oxymorphone (for conversion), and sufentanil be
reviewed for sufficiency and adjusted if necessary.
DEA Response: DEA sets the APQs in a manner to meet the estimated
medical, scientific, research, industrial needs of the United States,
lawful export requirements, and for the establishment and maintenance
of reserve stocks. As of the date the comment period closed for the
proposed adjusted 2024 APQ and AAN, DEA believes that the proposed
adjusted 2024 APQs are sufficient to meet the current estimated 2024
legitimate medical, scientific, research, and industrial needs of the
United States, for lawful export requirements, and to provide for
adequate reserve stock.
Issue: A DEA-registered manufacturer suggested several changes that
it believes are necessary to deter companies from using the quota
process to gain competitive advantage and to ensure that quota is
available when supply chain circumstances change. Among these, the
commenter suggested that DEA needs to obtain authority to reallocate
manufacturing quota from one registered bulk manufacturer to another in
the event that a finished dosage form manufacturer wishes, midyear, to
procure bulk material from a different bulk manufacturer than
originally planned.
DEA Response: This comment is outside the scope of the current
action, but DEA notes the commenter's suggestion for future
consideration. DEA currently can reallocate or revoke quotas in
specific circumstances as discussed in 21 CFR 1303.26 and 1303.36.
Issue: The same commenter who raised the immediately preceding
issue also suggested that DEA should change the procurement quota
application form (DEA Form 250) so that applicants can specify multiple
suppliers from which they may procure a basic class of bulk controlled
substance, as well as the estimated timeframe for receipt of the basic
class from each supplier.
DEA Response: The current procurement quota application form (DEA
Form 250) allows for the applicants to specify multiple suppliers from
which they may procure a basic class of bulk controlled substance, as
well as the estimated timeframe for receipt of the basic class from
each supplier.
Issue: The same commenter who raised the two immediately preceding
issues suggested that DEA specify, when granting quota, to which
specific finished dosage forms the quota is to be applied and the
proportion of the authorized amount that is to be used toward each
identified dosage form. The manufacturer further requested that DEA
verify during DEA inspections the manufacturer's compliance with the
details specified in the quota grant.
DEA Response: In 21 U.S.C. 826(a)(2), Congress granted DEA the
authority to delineate quota by pharmaceutical dosage form (tablets,
capsules, oral
[[Page 102639]]
liquids, etc.) if DEA determines it will assist in avoiding
overproduction, shortages, or diversion of a controlled substance. DEA
currently believes the designation of quota by dosage forms at the bulk
manufacturing level could lead to unforeseen circumstances such as
interference with production schedules or hindrance of the supply
chain. Moreover, in compliance with Congress's directive, DEA would
need to consider whether the application of such detail to quotas would
assist in avoiding overproduction, shortages, or diversion.
When a manufacturer has several customers that use the same active
pharmaceutical ingredient (API) to manufacture similar dosage forms
(i.e. brand and generic formulations), the terms of the contractual
agreements govern the transaction in normal circumstances. DEA does not
grant quota to fulfill specific business contracts between registrants;
rather, DEA grants quota to meet the legitimate medical, scientific,
research, and export requirements while ensuring the ability to
maintain adequate reserve stock.
Issue: The same commenter who raised the three immediately
preceding issues suggested that DEA assess ``quota usage'' on a
quarterly or semi-annual basis to verify that manufacturers timely
distribute materials that they are authorized under quota to
manufacture, and to require companies to surrender unused quotas so
that those unused amounts can be reassigned to others who can then
supply the market.
DEA Response: DEA has in the past and will continue to ask
manufacturers to surrender quota that they will not be able to utilize
in a timely manner (e.g., due to production scheduling issues,
malfunctioning of manufacturing lines, etc.). While DEA will note for
potential future consideration the commenter's suggestion that DEA
periodically assess quota usage, in a series of meetings held in the
spring of 2024, numerous API and dosage form manufacturers informed DEA
that a requirement to utilize quota quarterly would not be feasible
because of limited capacity of production lines and manufacturers'
strict adherence to production schedules. As a result of the
discussion, DEA is allotting commercial manufacturing procurement
quotas for Schedule II non-injectable products on a semi-annual basis.
Opioid Shortage Concerns
Issue: Nine commenters expressed general concerns regarding a
perceived nationwide shortage of opioid medication due to patients
experiencing intermittent out-of-stock or back-ordered situations at
pharmacies while attempting to fill their prescriptions.
DEA Response: DEA utilizes the available, reliable data and
information received by the agency in advance of publication; however
drug shortages may occur due to factors outside of DEA's control such
as manufacturing and quality problems, processing delays, supply chain
disruptions, or discontinuations. In such circumstances, if the drug
manufacturer notifies the U.S. Food and Drug Administration (FDA) Drug
Shortage Staff, FDA will coordinate with DEA to address and minimize
the impact of drug shortages if both agencies believe action is
warranted. Currently, FDA has not issued notice of any nationwide
shortages of the type of opioid medications mentioned by these
commenters.
Out of Scope Comments: DEA received other comments that were
general in nature and raised issues with respect to specific medical
illnesses and medical treatments. All of the issues raised are outside
of the scope of this final order for 2024 and do not impact the
analysis involved in finalizing the 2024 APQs.
Analysis for Final Adjusted 2024 Aggregate Production Quotas and
Assessment of Annual Needs
In determining the final adjusted 2024 APQs and AANs, DEA has
considered the above comments relevant to this final order for calendar
year 2024, along with the factors set forth in 21 CFR 1303.13 and 21
CFR 1315.13, in accordance with 21 U.S.C. 826(a). DEA has also
considered other relevant factors, including the 2023 year-end
inventories, initial 2024 manufacturing and import quotas, 2024 export
requirements, actual and projected 2024 sales, research and product
development requirements, additional applications received, and the
extent of any diversion of the controlled substance in the class. Based
on all of the above, the Administrator is finalizing the adjusted APQs
in the same amounts as proposed.
On July 29, 2024, DEA published a temporary scheduling order
placing N-desethyl isotonitazene and N-piperidinyl etonitazene in
schedule I of the CSA,\4\ and on October 25, 2024, DEA published a
final rule placing ethylphenidate in schedule I of the CSA,\5\ making
all regulatory controls pertaining to schedule I controlled substances
applicable to the manufacture of these substances, including the
requirement to establish an APQ pursuant to 21 U.S.C. 826 and 21 CFR
part 1303. This final order establishes an APQ for these substances for
the first time.
---------------------------------------------------------------------------
\4\ Schedules of Controlled Substances: Temporary Placement of
N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule
I, 89 FR 60817.
\5\ Schedules of Controlled Substances: Placement of
Ethylphenidate in Schedule I, 89 FR 84281.
---------------------------------------------------------------------------
Pursuant to the above, the Administrator hereby finalizes the 2024
APQs for the following schedule I and II controlled substances and the
2024 AANs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in grams of anhydrous acid or base, as
follows:
BILLING CODE 4410-P
[[Page 102640]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.086
[[Page 102641]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.087
[[Page 102642]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.088
[[Page 102643]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.089
[[Page 102644]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.090
[[Page 102645]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.091
[[Page 102646]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.092
[[Page 102647]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.093
[[Page 102648]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.094
BILLING CODE 4410-C
The Administrator also establishes that APQs for all other schedule
I and II controlled substances included in 21
[[Page 102649]]
CFR 1308.11 and 1308.12 remain at zero.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 13, 2024, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-30019 Filed 12-16-24; 8:45 am]
BILLING CODE 4410-09-P
