Notices. Final order

5,350 words·~24 min read·/register/2026/01/05/2025-24277·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4165-15-P 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. 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. 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). 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 *regulations.gov* , 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 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 2 Dispensing Controlled Substances for the Treatment of Pain, 71 FR 52716 (September 6, 2006). *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 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 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- * 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 4 90 FR 54745 (November 28, 2025). 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: Basic class Established 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-methoxymethamphetamine) 30 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-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 30 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 25 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) 30 2-(4-Ethoxybenzyl)-5-Nitro-1-(2-(Piperidin-1-yl)Ethyl)-1H-Benzimidazole (N-Piperidinyl Etonitazene) 30 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) 30 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) 30 2-(Ethylamino)-2-(3-Methoxyphenyl)Cyclohexan-1-One (Methoxetamine) 30 2-Methyl AP-237 30 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) 30 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 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-PVP) 25 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]-phenol 50 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 40 5-Fluoro-PB-22; 5F-PB-22 25 5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25 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-fluoropentyl)-1H-indazole-3-carboxamide 25 5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 25 5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 25 5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 25 5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide 25 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-one (alpha-PiHP) 30 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-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 30 ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 50 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 (α-PBP) 25 alpha-pyrrolidinoheptaphenone

(PV8)25 alpha-pyrrolidinohexabophenone (alpha-PHP) 25 alpha-Pyrrolidinopentiophenone (α-PVP) 25 Alphacetylmethadol 25 Alphameprodine 25 Alphamethadol 25 Amineptine 30 Aminorex 25 Anileridine 20 APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 25 Benzethidine 25 Benzylmorphine 30 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 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-naphthoyl)indole) 35 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-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 30 Marijuana 6,675,000 Marijuana extract 1,000,000 MDMB-4EN-PINACA 30 MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 30 MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 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)-3,3-dimethylbutanoate (4F-MDMB-BINACA) 30 Methyldesorphine 5 Methyldihydromorphine 25 Metodesnitazene 30 Metonitazene 30 MMB-CHMICA; (AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate 25 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-phenylcyclohexylamine 25 N-Ethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1h- benzimidazol-1-yl)ethan-1-amine; N-Desethyl Isotonitazene 30 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-carboxylate 25 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 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-methoxyphenylacetyl)indole) 45 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-yl](naphthalen-1-yl)methanone) 30 Tilidine 25 Trimeperidine 25 U-47700 30 UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25 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 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 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]

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Traces to 9 documents

U.S. Code