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<title>Federal Register, Volume 91 Issue 2 (Monday, January 5, 2026)</title>
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[Federal Register Volume 91, Number 2 (Monday, January 5, 2026)]
[Notices]
[Pages 287-297]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-24277]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1568E]
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 2026
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: This final order establishes the initial 2026 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 January 5, 2026.
FOR FURTHER INFORMATION CONTACT: Heather Achbach, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
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
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 2026 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
2026 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 November 28, 2025, 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 2026'' was published in
the Federal Register.\1\ This notice proposed the 2026 APQs for each
basic class of controlled substance listed in schedules I and II and
the 2026 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
December 15, 2025.
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\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
2026, 90 FR 54745 (November 28, 2025).
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III. Comments Received
Within the public comment period, DEA received 5,044 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 perceived domestic opioid drug
shortages due to further quota reductions; patient difficulty filling
authorized opioid and stimulant prescriptions; increases in drug
overdose deaths despite a continued decrease in production quotas;
concerns that medical professionals might be impeded from exercising
their medical expertise regarding opioid prescriptions; concerns of
ADHD medication efficacy and shortages based on quotas associated with
isomer ratios; ordering thresholds for pharmacies, data collection and
methodology; tools used to determine diversion estimates; adequate
quotas for research purposes, stake holder collaboration; requests for
a public hearing; requests for an extension to the comment period; and
comments not pertaining to DEA-regulated activities. While all comments
were posted to <a href="http://regulations.gov">regulations.gov</a>, DEA restricted the attachments to 22
comments from public view due to confidential business information and/
or confidential personal identifying information.
Pain Medication (Schedule II Opioids)
Issue (Medication Out of Stock at Pharmacy Level): Many commenters
expressed that due to the decreases in the aggregate production quotas
for oxycodone and hydrocodone, they have had difficulty filling
legitimate prescriptions. They stated they often experienced delays or
have to visit multiple pharmacies to get their prescriptions filled.
These issues have negatively impacted their quality of life and caused
mental health-related issues, possibly leading to suicide.
Additionally, commenters expressed concerns over the cardiovascular
effects they experienced when pain is left untreated for an extended
period of time due to the delay in getting medications.
DEA Response: DEA is committed to ensuring an adequate and
uninterrupted supply of controlled substances in order to meet
legitimate medical, scientific, and export needs of the United States.
DEA utilizes the available, reliable data and information received by
the agency at the time APQs are proposed and proactively monitors drug
production, distribution and supply during the year. 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 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 listed on its Drug Shortage website
any nationwide shortages of oxycodone and hydrocodone products.
Additionally, if a patient is faced with a delay in
[[Page 288]]
receiving their medications, the patient may request a one-time
transfer of initial dispensing of an electronic prescription for
Schedules II-V controlled substances from one retail pharmacy to
another retail pharmacy if authorized under state law. If the
medication is a controlled substance in Schedules III-V and includes
authorized refills, the refills can also be transferred with the
initial prescription to the receiving pharmacy.
Issue: (Shortage of injectable opioid products): DEA received
comments from palliative care associations, healthcare companies, and
manufacturers regarding the listing of injectable opioid medications
including fentanyl, hydromorphone, and morphine on the FDA's Drug
Shortage website and the proposed reduction of the APQs for fentanyl,
hydromorphone, and morphine.
DEA Response: DEA is committed to ensuring an adequate and
uninterrupted supply of controlled substances in order to meet the
estimated legitimate medical, scientific, research, and industrial
needs of the United States, for lawful export requirements, and for the
establishment and maintenance of reserve stocks. Opioid injectable
products utilize less than 5% of the relevant APQ. The remainder of the
APQ is used to manufacture other opioid dosage forms. Therefore,
injectable shortages do not usually require changes to the relevant
APQ. Based on the data that DEA is required to consider for setting the
APQs, DEA has determined that the established APQs for opioids are
sufficient to meet all legitimate needs for 2026. As mentioned above,
DEA proactively monitors drug production, distribution and supply
during the year. Additionally, DEA and FDA are required to, and
routinely do, coordinate efforts to prevent or alleviate drug shortages
pursuant to 21 U.S.C. 826(h). Such efforts may include adjusting the
APQ, adjusting individual domestic manufacturers' quotas, FDA approval
of additional market competitors, and coordination between the agencies
to allow importation of foreign-manufactured drug products that meet
FDA approval.
Issue (Opioid Prescribing Hesitancy): Many self-identified chronic
pain patients expressed that they are obtaining opioid pain medications
legally and taking them as prescribed. Commenters stated that many
chronic pain patients experience a decreased quality of life, and some
have died by suicide, due to the inability to get prescriptions from
their providers, which they allege is directly related to the APQ
reductions made by DEA. Many commenters also stated that restrictions
imposed by DEA have caused opioid medications to be under-prescribed
due to fear of prosecution. Commenters said doctors should have
latitude in making treatment decisions to prescribe opioid pain
medications based on individual patient needs.
DEA Response: DEA's regulations do not impose restrictions on the
amount and the type of medication that licensed practitioners can
prescribe. DEA has consistently emphasized and supported the authority
of individual practitioners under the CSA to administer, dispense, and
prescribe controlled substances for the legitimate treatment of pain
within acceptable medical standards, as outlined in DEA's policy
statement ``Dispensing Controlled Substances for the Treatment of
Pain'' published in the Federal Register on September 6, 2006.\2\
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\2\ Dispensing Controlled Substances for the Treatment of Pain,
71 FR 52716 (September 6, 2006).
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Issue (Patients Switching to Illicit Fentanyl or Medications
Obtained from Illegal Sources): Several commenters expressed concerns
that chronic pain sufferers will turn to illegal fentanyl or
medications obtained from illegitimate sources for relief if they are
unable to fill their legitimate prescriptions due to the reduction of
quotas for opioids. They stated that overdose deaths in the United
States continue to rise as a result of illegal fentanyl or illegitimate
medications, rather than from legally prescribed medications for the
treatment of chronic pain.
DEA Response: DEA considered various factors such as the estimation
of legitimate medical need provided by the Department of Health and
Human Services (HHS), as well as the extent of any diversion, when
proposing and establishing the APQs for opioids to ensure there is an
adequate supply to meet legitimate medical demand while preventing
diversion (21 CFR 1303.11(b)). Pursuant to the Substance Use-Disorder
Prevention that Promotes Opioid Recovery and Treatment for Patients and
Communities (SUPPORT) Act (Pub. L. 115-271), DEA is mandated to
estimate diversion for fentanyl, hydrocodone, hydromorphone, oxycodone
and oxymorphone, and this estimation includes the consideration of
rates of overdose deaths. While overdose deaths may still occur from
the use of illicit substances, DEA implemented quota regulations such
that the occurrences of overdose and death caused by the misuse and
diversion of pharmaceutical controlled substances are reduced. Patients
are encouraged to work closely with their licensed healthcare
practitioners to utilize FDA-approved medications for their conditions
and to fill their prescriptions only from DEA-registered pharmacies.
Medications received from unregistered internet sources may, in fact,
be manufactured or laced with illicit substances including illicit
fentanyl, which contribute to rates of overdose deaths.
Attention Deficit/Hyperactivity Disorder (ADHD) Medication
Issue (isomer ratio): Several self-identified ADHD patients claimed
that they have been negatively impacted by the poor quality and
ineffectiveness of their prescribed Adderall or amphetamine mixed salt
products. They claimed that the manufacturing of Adderall dosages
requires a 3:1 isomeric ratio of d-amphetamine to l-amphetamine, and
that dosage form manufacturers are unable to procure the proper ratio
of isomers because DEA is allocating d-amphetamine and l-amphetamine to
dosage manufacturers in a fixed one-to-one ratio, thus affecting the
effectiveness and quality of the medication and a shortage of the
medication.
Response: The FDA is a regulatory agency under HHS that has the
authority to oversee and regulate the safety, efficacy and
manufacturing quality of drugs sold in the United States. The FDA
monitors and ensures manufacturers' compliance with all applicable
requirements, including Current Good Manufacturing Practices (cGMP)
regulations. Patients should raise concerns with their licensed
healthcare provider or pharmacist if they find that their prescribed
medications are ineffective in treating their conditions.
DEA does not allocate d-amphetamine and l-amphetamine quotas in a
fixed one-to-one ratio because the manufacturers do not request d-
amphetamine and l-amphetamine quotas in a 1:1 ratio. When DEA upgraded
the quota application process from paper to electronic, DEA noticed
that manufacturers did not request quota for l-amphetamine but,
preferred to request quota for d,l-amphetamine. The d,l-amphetamine APQ
represents the racemic mixture of d- and l-amphetamine expressed as
base. A racemic mixture is considered a 50:50 ratio of left and right-
handed mirror images, in this instance, the 50:50 ratio is of d-
amphetamine and l-amphetamine. Therefore, the currently established and
proposed aggregate production quotas of d,l-amphetamine and d-
amphetamine are allocated to
[[Page 289]]
manufacturers in a proper ratio such that amphetamine mixed salt
products can be manufactured in accordance with the drug's approval,
following cGMP standards and quality control practices as required by
FDA.
Ordering Thresholds for Pharmacies
Issue: Commenters mentioned that as a result of the national opioid
settlements, wholesale drug distributors have increasingly imposed
ordering thresholds or limits on pharmacies, thereby impacting patient
access to opioids. According to the commenters, distributors often flag
an increase in controlled substance orders by pharmacies as suspicious,
which can lead to denials or contract termination. Pharmacies with a
record of distributor-initiated contract terminations may then face
difficulties in securing new contracts with other distributors, as
prior terminations are viewed as red flags. Therefore, pharmacies may
be unwilling to increase their purchasing orders to meet legitimate
medical need for fear that doing so could trigger distributors to
cancel their contract. A commenter also expressed concerns that valid
prescriptions to patients in hospice may not be fulfilled because
pharmacies are unwilling to increase their controlled substances orders
in fear of contract cancellations. The commenters encourage DEA to
ensure that distributors are properly identifying and evaluating
suspicious orders, and to allow pharmacies that were unintentionally
suspended or terminated by their distributors to undergo a voluntary
DEA inspection to verify that the prescriptions they filled were
legitimate.
DEA Response: The APQs established by DEA set a limit to the total
quantity of a controlled substance that may be produced by all
manufacturers in a calendar year, and do not impose any ordering
thresholds or limits to pharmacies purchasing controlled substance
medications from distributors.
Establishing APQs in Terms of Dosage Forms
Issue: DEA received a comment from a healthcare company suggesting
DEA establish the annual APQs in terms of pharmaceutical dosage forms.
DEA Response: Pursuant to 21 U.S.C. 826(a)(1), ``production quotas
shall be established in terms of quantities of each basic class of
controlled substance and not in terms of individual pharmaceutical
dosage forms prepared from or containing such a controlled substance.''
DEA sets APQ in a manner to support legitimate domestic medical need,
exports, scientific research and product development, as well as
maintaining reserve stocks. In turn, the APQ takes into consideration
all FDA approved dosage forms to meet the estimated medical needs of
the United States. 21 U.S.C. 826(a)(2) provides an exception to that
general rule by allowing, but not requiring, DEA to grant quotas in
terms of dosage forms if DEA determines that doing so will assist in
avoiding the overproduction, shortage, or diversion of controlled
substances. DEA has utilized this authority to issue individual
manufacturing quotas in terms of dosage form when necessary, where it
can be more effective in averting potential shortages. Since quotas set
at the individual dosage-form manufacturing level are more directly
connected to distributions of FDA-approved drug products, DEA can use
its dosage-form authority to alleviate any potential shortage in a more
timely manner at the individual manufacturing quota level than at the
aggregate production quota level. By issuing a single APQ covering all
dosage forms of the basic class, rather than estimating an APQ for each
dosage form, DEA retains the flexibility to alleviate potential
shortages and to react to unforeseen emergencies by adjusting the
individual quotas granted to manufacturers under that APQ.
Data Collection and Methodology
Issue (Lack of Real-Time Data): A few commenters opined that DEA
lacks real-time data on opioid inventory, production and distribution.
They suggested this lack of real-time data makes it difficult for DEA
to accurately assess legitimate medical needs of patients and ensure
adequate supply of opioid pain medications.
DEA Response: DEA has access to current sales data provided by
manufacturers from the Quota and Year-end Reporting Management System
(QMS), Automation of Reports and Consolidated Orders System (ARCOS)
reports, and monthly IQVIA data when determining legitimate medical
needs to ensure an adequate supply of medications containing schedule
II-controlled substances. While manufacturers and distributors have a
choice on reporting their distributions monthly or quarterly under 21
CFR 1304.33, at the DEA Annual Supply Chain Conferences in April 2024
and April 2025, DEA requested manufacturers and distributors to report
sales data into the ARCOS database on a monthly basis, which improves
the timeliness and accuracy of data points DEA uses to estimate
legitimate medical needs.
Issue (over-reliance on historical trends): Several commenters
opined that the quota-setting process overly relies on historical
trends that do not adequately reflect patient population changes and
new prescribing trends, stating that DEA relies on data that is
outdated and incomplete, resulting in arbitrary cuts to the APQs of
opioids and suppression of APQs for ADHD medications.
DEA Response: When developing the annual APQs, DEA routinely
evaluates data from multiple sources to ensure that all the legal
factors specified in 21 CFR 1303.11(b) are adequately addressed. DEA's
quota process not only relies on current and historical trends, but it
also incorporates the most up to date information provided by the FDA
and registered manufacturers. For example, DEA utilizes information
provided by quota applicants to derive the estimates of scientific,
research, and industrial needs, lawful export requirements, as well as
current reserve stocks. The information DEA receives from FDA includes
the observed and projected domestic usage of schedule II-controlled
substances, new drug application and abbreviated new drug application
approvals, manufacturers discontinuing production, product shortages,
and clinical trials for schedule I and II controlled substances. FDA
utilizes a variety of data sources in developing its estimates and
describes certain caveats regarding the forecasts it provides. The data
provided by FDA, as well as the data obtained from registered
manufacturers, DEA's internal databases, and third party prescription
data from IQVIA and MIDAS, all contributed to DEA's proposed APQs to
meet legitimate estimated domestic manufacturing needs for the
controlled substances listed in the table.
Diversion Estimates
Issue (red flags): Commenters raised concerns with DEA's
methodology for estimating diversion using PDMP ``red flags'' data.
Commenters state that the data captured in these ``red flags'' metrics
can also represent legitimate patient care such as changing doctors,
doctors retiring, multi-specialty care, and paying cash due to loss of
health insurance.
DEA Response: DEA has worked with investigators and subject matter
experts to select potential indicators of diversion. DEA's Diversion
Control Division identified over-prescribing, doctor shopping, and cash
payments as risk indicators related to its quota setting function.
While it is possible that a legitimate prescription for an opioid might
meet one of these criteria, in
[[Page 290]]
DEA's experience the number of such legitimate prescriptions would be
minimal and unlikely to significantly impact the diversion calculation.
Comments From Pharmaceutical Manufacturers
Issue (Request for Data Sharing): DEA received a comment from a
pharmaceutical manufacturer stating that the data DEA utilizes to
determine quotas should be shared with manufacturers.
DEA Response: DEA considers ARCOS data which is provided by
registered manufacturers and distributors. DEA provides access to
manufacturers and distributors of this data through the use of the
``ARCOS lookup'' tool available to DEA registrants on DEA's website.
Additionally, DEA cannot provide access to the underlying data used in
calculating the manufacturing, procurement, or import quotas because it
includes confidential business information.
While DEA has stated it considers prescription data from IQVIA, a
third party, DEA purchases this data under contract and is not
permitted to share the data. Any pharmaceutical company can contract to
purchase data from IQVIA or any other company that supplies
prescription data.
Issue (APQ adjustment for research): DEA received comments from
pharmaceutical companies regarding advanced research and clinical
trials of several schedule I controlled substances, requesting the APQs
be established at sufficient levels to allow for their manufacturing to
meet research and scientific needs.
DEA Response: DEA considered these comments and matched them to the
contracted DEA-registered manufacturers and determined that the
specific schedule I controlled substance APQs are sufficient to support
the legitimate research and scientific efforts toward an FDA-approved
drug product.
Stakeholder Collaboration
Issue: Several commenters including palliative care associations
and a healthcare company suggested that DEA should collaborate with a
broad range of stakeholders on how DEA can address the opioid crisis
while ensuring legitimate medical needs are met.
DEA Response: DEA has and will continue to collaborate with federal
agencies, industry, and medical associations to combat the opioid
crisis, prevent diversion, and set appropriate manufacturing quantities
of controlled substances and chemicals to meet legitimate need and
preparedness for unforeseen circumstances within the United States. In
addition, DEA has engaged with pharmaceutical manufacturers and private
sector entities with relevant pharmaceutical information through
roundtable discussions and data sharing efforts. DEA is willing to meet
with relevant private organizations upon request when presented with
good cause.
Request for Hearing
Issue: Sixty commenters suggested that DEA consider holding a
public hearing to provide patient testimony regarding the APQs and AANs
economic impact on public health.
DEA Response: The decision whether to grant a hearing on the issues
raised by the commenters lies solely within the discretion of the
Administrator. While hearings are required when requested by states in
certain situations, these requests were not submitted by states. These
requests did not include any evidence that would lead to the conclusion
that a hearing is necessary or warranted. DEA appreciates the written
comments provided by patients and has addressed specific points raised
by the commenters in the issues and responses above.
Comment Period Length
Issue: DEA received 15 comments questioning why the comment period
was compressed to 15 calendar days and 10 comments requesting an
extension of the comment period.
DEA Response: The comment period was compressed to 15 calendars
days in part due to the government shutdown from October 1 to November
12, 2025. DEA provides the opportunity for comment on the 2026 proposed
APQ and AAN as required by 21 CFR 1303.11(c) and 1315.11(d), which
establish that the Administrator shall permit any interested person to
file written comments on or objections to the proposal and shall
designate in the notice the time during which such filings may be made.
Out of Scope Comments
DEA received comments that are outside the scope of this order. The
comments were general in nature and included but not limited to issues
such as specific medical illnesses, medical treatments, perceived
ineffectiveness of suboxone and its potential side effects, and
medication costs. These comments are outside the scope of this Final
Order and do not impact the analysis involved in establishing the 2026
APQs.
IV. Determination of 2026 Aggregate Production Quotas and Assessment of
Annual Needs
In determining the established 2026 APQs and AANs, DEA has
considered the above comments along with the factors set forth in 21
CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a).
These factors include, but are not limited to, the 2025 manufacturing
quotas, current 2025 sales and inventories, anticipated 2026 export
requirements, industrial use, additional applications for 2026 quotas,
and information on research and product development requirements.
Schedule I Controlled Substances
On July 25, 2025, DEA established a specific listing for
dipentylone in schedule I of the Controlled Substances Act (CSA)
because it is a positional isomer of N-ethylpenthylone, which is a
schedule I hallucinogen (90 FR 38396), making all regulatory controls
pertaining to schedule I controlled substances applicable to the
manufacture of this substance, including the requirement to establish
an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part
1303. This final order establishes an aggregate production quota for
this substance.
On August 15, 2025, DEA published a temporary scheduling order
placing N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in
schedule I of the CSA (90 FR 39314), making all regulatory controls
pertaining to schedule I controlled substances applicable to the
manufacture of these substances, including the requirement to establish
an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part
1303. This final order establishes an aggregate production quota for
these substances.
On October 15, 2025, DEA published a temporary scheduling order
placing Ethyleneoxynitazene, Methylenedioxynitazene, 5-methyl
etodesnitazene, N-desethyl etonitazene, N-desethyl protonitazene, N,N-
dimethylamino etonitazene, and N-pyrrolidino isotonitazene in schedule
I of the CSA (90 FR 48259), making all regulatory controls pertaining
to schedule I controlled substances applicable to the manufacture of
these substances, including the requirement to establish an aggregate
production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This
final order establishes an aggregate production quota for these
substances.
DEA published a final rule on September 18, 2025 placing beta-
methylacetyl fentanyl, meta-
[[Page 291]]
fluorofuranyl fentanyl, ortho-chlorofentanyl, ortho-methylcyclopropyl
fentanyl, para-chlorofentanyl, para-fluoro valeryl fentanyl, and
tetrahydrothiofuranyl fentanyl in schedule I of the CSA (90 FR 44979),
and also published a final rule on November 17, 2025 placing 4-
Chloromethcathinone in schedule I of the CSA (90 FR 51102), making all
regulatory controls pertaining to the schedule I controlled substances
applicable to the manufacture of these substances, including the
requirement to establish an aggregate production quota pursuant to 21
U.S.C. 826 and 21 CFR part 1303. This final order establishes an
aggregate production quota for these substances.
Schedule II Controlled Substances
Based on all of the above, the Administrator establishes the 2026
APQs for d, l-amphetamine, d-amphetamine (for conversion),
dimethyltryptamine, lisdexamfetamine, morphine (for sale), oripavine,
psilocybin, and psilocyn at higher levels than were proposed.
Estimates of Diversion
As specified in the proposal, and as required by 21 U.S.C. 826(i),
DEA calculated a national diversion estimate for each of the five
covered controlled substances. This data, which remains unchanged, was
published in the 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 2026.\4\
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\4\ 90 FR 54745 (November 28, 2025).
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In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Administrator hereby establishes the 2026 APQs for the
following schedule I and II controlled substances and the 2026 AANs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, expressed in grams of anhydrous acid or base, as
follows:
------------------------------------------------------------------------
Established
Basic class 2026 quotas
(g)
------------------------------------------------------------------------
Temporary Schedule I
------------------------------------------------------------------------
5-Methyl Etodesnitazene................................. 30
Ethyleneoxynitazene..................................... 30
Methylenedioxynitazene.................................. 30
N,N-Dimethylamino Etonitazene........................... 30
N-Desethyl Etonitazene.................................. 30
N-Desethyl Protonitazene................................ 30
N-Pyrrolidino Isotonitazene............................. 30
N-pyrrolidino Metonitazene.............................. 30
N-pyrrolidino Protonitazene............................. 30
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine.................. 20
1-(1-Phenylcyclohexyl)pyrrolidine....................... 30
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.......... 10
1-(4-Methoxyphenyl)-N-methylpropan-2-amine (Para- 30
methoxymethamphetamine)................................
1-(5-Fluoropentyl)-3-(1-naphthoyl) indole (AM2201)...... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole (AM694)..... 30
1-Benzylpiperazine...................................... 25
1-Methyl-4-phenyl-4-propionoxypiperidine................ 10
1'[1-(2-Thienyl)cyclohexyl]piperidine................... 15
2'-Fluoro 2-fluorofentanyl.............................. 30
2,5-Dimethoxy-4-Ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-[N]-Propylthiophenethylamine............ 25
2,5-Dimethoxyamphetamine................................ 25
2-(2,5-Dimethoxy-4-(N)-propylphenyl)ethanamine (2C-P)... 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Ethoxybenzyl)-5-Nitro-1-(2-(Piperidin-1-yl)Ethyl)- 30
1H-Benzimidazole (N-Piperidinyl Etonitazene)...........
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(Ethylamino)-2-(3-Methoxyphenyl)Cyclohexan-1-One 30
(Methoxetamine)........................................
2-Methyl AP-237......................................... 30
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 30
3,4-Methylenedioxyamphetamine (MDA)..................... 12,000
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 30,000
3,4-Methylenedioxymethamphetamine (MDMA)................ 12,000
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-FMC; 3-Fluoro-N-methylcathinone....................... 25
[[Page 292]]
3-Methylfentanyl........................................ 30
3-Methylthiofentanyl.................................... 30
3-Methylmethcathinone................................... 30
4'-Methyl acetyl fentanyl............................... 30
4'-Methyl-alpha-pyrrolidinohexiophenone (MPHP).......... 25
4,4'-Dimethylaminorex................................... 30
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 5,100
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha- 25
PVP)...................................................
4-Chloromethcathinone................................... 30
4-CN-Cumyl-Butinaca..................................... 25
4-Fluoroisobutyryl fentanyl............................. 30
4-FMC; Flephedrone...................................... 25
4-MEC; 4-Methyl-N-ethylcathinone........................ 25
4-Methoxyamphetamine.................................... 150
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)......... 25
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP)....... 25
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methylaminorex........................................ 25
4F-MDMB-BUTICA.......................................... 30
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 50
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5-Fluoro-PB-22; 5F-PB-22................................ 25
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3- 25
yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
5-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 30,000
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H- 25
indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 25
carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide)...............
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2- 25
yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide.............
5F-CUMYL-PINACA......................................... 25
5F-EDMB-PICA............................................ 30
5F-EDMB-PINACA.......................................... 25
5F-MDMB-PICA............................................ 25
A-PIHP; 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1- 30
one (alpha-PiHP).......................................
AB-CHMINACA............................................. 30
AB-FUBINACA............................................. 50
AB-PINACA............................................... 30
Acetorphine............................................. 25
Acetyl Fentanyl......................................... 100
Acetyl-alpha-methylfentanyl............................. 30
Acetyldihydrocodeine.................................... 30
Acetylmethadol.......................................... 25
Acryl Fentanyl.......................................... 25
ADB-4en-PINACA.......................................... 30
ADB-BUTINACA............................................ 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 30
(4-fluorobenzyl)-1H-indazole-3-carboxamide)............
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 50
pentyl-1H-indazole-3-carboxamide)......................
AH-7921................................................. 30
All other tetrahydrocannabinol.......................... 1,166,130
Allylprodine............................................ 25
alpha-Ethyltryptamine................................... 25
alpha-Methylfentanyl.................................... 30
alpha-Methylthiofentanyl................................ 30
alpha-Methyltryptamine (AMT)............................ 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 25
alpha-pyrrolidinoheptaphenone (PV8)..................... 25
alpha-pyrrolidinohexabophenone (alpha-PHP).............. 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 25
Alphacetylmethadol...................................... 25
Alphameprodine.......................................... 25
Alphamethadol........................................... 25
Amineptine.............................................. 30
Aminorex................................................ 25
Anileridine............................................. 20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3- 25
carboxamide)...........................................
Benzethidine............................................ 25
Benzylmorphine.......................................... 30
[[Page 293]]
beta-Hydroxy-3-methylfentanyl........................... 30
beta-Hydroxyfentanyl.................................... 30
beta-Hydroxythiofentanyl................................ 30
beta-Methyl fentanyl.................................... 30
beta-Methylacetyl fentanyl.............................. 30
Beta'-Phenyl fentanyl................................... 30
Betacetylmethadol....................................... 25
Betameprodine........................................... 25
Betamethadol............................................ 4
Betaprodine............................................. 25
Brorphine............................................... 30
Bufotenine.............................................. 15
Butonitazene............................................ 30
Butylone................................................ 25
Butyryl fentanyl........................................ 30
Cathinone............................................... 40
Clonazolam.............................................. 30
Clonitazene............................................. 25
Codeine methylbromide................................... 30
Codeine-N-oxide......................................... 192
Crotonyl Fentanyl....................................... 25
CUMYL-PEGACLONE......................................... 30
Cyclopentyl Fentanyl.................................... 30
Cyclopropyl Fentanyl.................................... 20
Cyprenorphine........................................... 25
delta-9-Tetrahydrocannabinol............................ 1,523,040
Desomorphine............................................ 25
Dextromoramide.......................................... 25
Diapromide.............................................. 20
Diclazepam.............................................. 30
Diethylthiambutene...................................... 20
Diethyltryptamine....................................... 25
Difenoxin............................................... 9,300
Dihydromorphine......................................... 639,954
Dimenoxadol............................................. 25
Dimepheptanol........................................... 25
Dimethylthiambutene..................................... 20
Dimethyltryptamine...................................... 25,000
Dioxyaphetyl butyrate................................... 25
Dipentylone............................................. 30
Dipipanone.............................................. 25
Drotebanol.............................................. 25
Ethylmethylthiambutene.................................. 25
Ethylone................................................ 25
Ethylphenidate.......................................... 30
Etizolam................................................ 30
Etodesnitazene.......................................... 30
Etonitazene............................................. 25
Etorphine............................................... 30
Etoxeridine............................................. 25
Eutylone................................................ 30
Fenethylline............................................ 30
Fentanyl carbamate...................................... 30
Fentanyl related substances............................. 600
Flualprazolam........................................... 30
Flubromazolam........................................... 30
Flunitazene............................................. 30
FUB-144................................................. 25
FUB-AKB48............................................... 25
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca..................... 25
Furanyl fentanyl........................................ 30
Furethidine............................................. 25
Gamma-Hydroxybutyric acid............................... 49,675,266
Heroin.................................................. 150
Hydromorphinol.......................................... 40
Hydroxypethidine........................................ 25
Ibogaine................................................ 210
Isobutyryl Fentanyl..................................... 25
Isotonitazine........................................... 25
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)...... 35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)................. 45
[[Page 294]]
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)................. 45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)..... 30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)....... 30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 35
naphthoyl)indole)......................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)....... 30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)...... 30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)....... 30
Ketobemidone............................................ 30
Levomoramide............................................ 25
Levophenyacylmorphan.................................... 25
Lysergic acid diethylamide (LSD)........................ 1,200
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)...........................................
Marijuana............................................... 6,675,000
Marijuana extract....................................... 1,000,000
MDMB-4EN-PINACA......................................... 30
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)- 30
1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole- 30
3-carboxamido)-3,3-dimethylbutanoate)..................
Mecloqualone............................................ 30
Mescaline............................................... 1,200
Mesocarb................................................ 30
Meta-Fluorofuranyl fentanyl............................. 30
Methaqualone............................................ 60
Methcathinone........................................... 25
Methiopropamine......................................... 30
Methoxyacetyl fentanyl.................................. 30
Methyl 2-(1-(4-fluorobutyl)-1h-indazole-3-carboxamido)- 30
3,3-dimethylbutanoate (4F-MDMB-BINACA).................
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 25
Metodesnitazene......................................... 30
Metonitazene............................................ 30
MMB-CHMICA; (AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)- 25
1H-indole-3-carboxamido)-3-methylbutanoate.............
MMB-FUBICA.............................................. 30
Morpheridine............................................ 25
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 150
MT-45................................................... 30
Myrophine............................................... 25
N,N-Dimethylamphetamine................................. 25
N-Ethyl-1-phenylcyclohexylamine; N-Ethyl-1- 25
phenylcyclohexylamine..................................
N-Ethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1h- 30
benzimidazol-1-yl)ethan-1-amine; N-Desethyl
Isotonitazene..........................................
N-Ethyl-3-piperidyl benzilate........................... 10
N-Ethylamphetamine...................................... 24
N-Ethylhexedrone........................................ 25
N-Ethylpentylone, ephylone.............................. 30
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
N-Methyl-3-piperidyl benzilate.......................... 30
N-Pyrrolidino Etonitazene............................... 30
Naphyrone............................................... 25
Nicocodeine............................................. 25
Nicomorphine............................................ 25
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3- 25
carboxylate............................................
Noracymethadol.......................................... 25
Norlevorphanol.......................................... 2,550
Normethadone............................................ 25
Normorphine............................................. 40
Norpipanone............................................. 25
Ocfentanil.............................................. 25
ortho-Chlorofentanyl.................................... 30
ortho-Fluoroacryl fentanyl.............................. 30
ortho-Fluorobutyryl fentanyl............................ 30
ortho-Fluorofentanyl,2-Fluorofentanyl................... 30
ortho-Fluoroisobutyryl fentanyl......................... 30
ortho-Methyl acetylfentanyl............................. 30
ortho-Methylcyclopropyl fentanyl........................ 30
ortho-Methyl methoxyacetyl fentanyl..................... 30
para-Chlorofentanyl..................................... 30
para-Chloroisobutyrl fentanyl........................... 30
para-Flourobutyryl fentanyl............................. 25
para-Fluorofentanyl..................................... 25
[[Page 295]]
para-Fluoro furanyl fentanyl............................ 30
para-Fluoro valeryl fentanyl............................ 30
para-Methoxybutyrl fentanyl............................. 30
para-Methylfentanyl..................................... 30
Parahexyl............................................... 5
PB-22; QUPIC............................................ 20
Pentedrone.............................................. 25
Pentylone............................................... 25
Phenadoxone............................................. 25
Phenampromide........................................... 25
Phenomorphan............................................ 25
Phenoperidine........................................... 25
Phenyl fentanyl......................................... 30
Pholcodine.............................................. 5
Piritramide............................................. 25
Proheptazine............................................ 25
Properidine............................................. 25
Propiram................................................ 25
Protonitazene........................................... 30
Psilocybin.............................................. 50,000
Psilocyn................................................ 80,000
Racemoramide............................................ 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30
Tetrahydrofuranyl fentanyl.............................. 15
Tetrahydrothiofuranyl fentanyl.......................... 30
Thebacon................................................ 25
Thiafentanil............................................ 25
Thiofentanyl............................................ 25
Thiofuranyl fentanyl.................................... 30
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 30
yl](naphthalen-1-yl)methanone).........................
Tilidine................................................ 25
Trimeperidine........................................... 25
U-47700................................................. 30
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25
tetramethylcyclopropyl)methanone.......................
Valeryl fentanyl........................................ 25
Zipeprol................................................ 30
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 15
1-Piperidinocyclohexanecarbonitrile..................... 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 937,874
Alfentanil.............................................. 5,000
Alphaprodine............................................ 25
Amobarbital............................................. 20,100
Bezitramide............................................. 25
Carfentanil............................................. 20
Cocaine................................................. 60,492
Codeine (for conversion)................................ 942,452
Codeine (for sale)...................................... 19,262,516
d-Amphetamine (for conversion).......................... 34,602,790
d-Amphetamine (for sale)................................ 26,450,000
d-Methamphetamine (for conversion)...................... 485,020
d-Methamphetamine (for sale)............................ 47,000
d,l-Amphetamine......................................... 24,234,443
d,l-Methamphetamine..................................... 150
Dexmethylphenidate (for conversion)..................... 5,374,683
Dexmethylphenidate (for sale)........................... 6,200,000
Dextropropoxyphene...................................... 35
Dihydrocodeine.......................................... 115,227
Dihydroetorphine........................................ 25
Diphenoxylate (for conversion).......................... 14,100
Diphenoxylate (for sale)................................ 770,800
Ecgonine................................................ 60,492
Ethylmorphine........................................... 30
Etorphine hydrochloride................................. 32
Fentanyl................................................ 731,236
Glutethimide............................................ 25
Hydrocodone (for conversion)............................ 1,250
Hydrocodone (for sale).................................. 26,978,077
[[Page 296]]
Hydromorphone........................................... 1,949,378
Isomethadone............................................ 30
l-Amphetamine........................................... 30
l-Methamphetamine....................................... 587,229
Levo-alphacetylmethadol (LAAM).......................... 25
Levomethorphan.......................................... 30
Levorphanol............................................. 20,000
Lisdexamfetamine........................................ 51,290,743
Meperidine.............................................. 681,184
Meperidine Intermediate-A............................... 30
Meperidine Intermediate-B............................... 30
Meperidine Intermediate-C............................... 30
Metazocine.............................................. 15
Methadone (for sale).................................... 25,619,700
Methadone Intermediate.................................. 27,673,600
Methamphetamine......................................... 150
Methylphenidate (for conversion)........................ 19,975,468
Methylphenidate (for sale).............................. 58,283,000
Metopon................................................. 25
Moramide-intermediate................................... 25
Morphine (for conversion)............................... 2,393,200
Morphine (for sale)..................................... 23,000,000
Nabilone................................................ 62,000
Norfentanyl............................................. 25
Noroxymorphone (for conversion)......................... 24,756,979
Noroxymorphone (for sale)............................... 2,500
Oliceridine............................................. 25,100
Opium (powder).......................................... 250,000
Opium (tincture)........................................ 530,837
Oripavine............................................... 45,721,950
Oxycodone (for conversion).............................. 437,827
Oxycodone (for sale).................................... 50,237,652
Oxymorphone (for conversion)............................ 31,773,105
Oxymorphone (for sale).................................. 464,367
Pentobarbital........................................... 40,000,000
Phenazocine............................................. 25
Phencyclidine........................................... 35
Phenmetrazine........................................... 25
Phenylacetone........................................... 100
Piminodine.............................................. 25
Racemethorphan.......................................... 5
Racemorphan............................................. 5
Remifentanil............................................ 4,000
Secobarbital............................................ 172,100
Sufentanil.............................................. 4,000
Tapentadol.............................................. 10,390,226
Thebaine................................................ 57,137,944
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 41,100
Ephedrine (for sale).................................... 3,933,336
Phenylpropanolamine (for conversion).................... 14,878,320
Phenylpropanolamine (for sale).......................... 7,990,000
Pseudoephedrine (for conversion)........................ 1,000
Pseudoephedrine (for sale).............................. 186,617,466
------------------------------------------------------------------------
The Administrator also establishes APQs for all other schedule I
and II controlled substances included in 21 CFR 1308.11 and 1308.12 at
zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon
consideration of the relevant factors, the Administrator may adjust the
2026 APQ and AAN as needed.
Signing Authority
This document of the Drug Enforcement Administration was signed on
December 31, 2025, by Administrator Terrance Cole. 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
[[Page 297]]
document upon publication in the Federal Register.
Leslie Mayer,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-24277 Filed 1-2-26; 8:45 am]
BILLING CODE P
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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 2026
This final order establishes the initial 2026 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of ...
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91 FR 287
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“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 2026,” thefederalregister.org (January 5, 2026), https://thefederalregister.org/documents/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment-of-annual-needs-for-t.