Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule[...]

Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act

SUPPLEMENTARY INFORMATION:

The Drug Enforcement Administration (DEA) issues a temporary scheduling order  ⁽¹⁾ (in the form of a temporary amendment) to add the following four synthetic opioids, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, to schedule I under the Controlled Substances Act (CSA):

• 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-5,6-dichloro-1,3-dihydro-2 H -benzo[ d ]imidazol-2-one (Other names: 5,6-dichloro brorphine or SR-14968)

• 5,6-dichloro-1-(1-(4-chlorobenzyl)piperidin-4-yl)-1,3-dihydro-2 H -benzo[ d ]imidazol-2-one (Other names: 5,6-dichloro desmethylchlorphine or SR-17018)

• 3-(3-(1-(1-(4-chlorophenyl)ethyl)piperidin-4-yl)-2-oxo-2,3-dihydro-1 H -benzo[ d ]imidazol-1-yl)propanenitrile (Other names: N -propionitrile chlorphine or cychlorphine)

• 8-(1-(4-chlorophenyl)ethyl)-1-phenyl-1,3,8-triazaspiro[4.5]decan-4-one (Other names: spirochlorphine or R-6890)

Legal Authority

The CSA provides the Attorney General with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the evaluation requirements of 21 U.S.C. 811(b), if he finds that such action is necessary to avoid an imminent hazard to the public safety. ⁽²⁾ In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily controlled under section 811(h), the Attorney General may extend the temporary scheduling for up to one year. ⁽³⁾

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355. ⁽⁴⁾ The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of DEA (Administrator). ⁽⁵⁾

Background

The CSA requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of an intent to temporarily place a substance in schedule I of the CSA ( i.e., to issue a temporary scheduling order). ⁽⁶⁾ By letter dated April 1, 2026, the Administrator transmitted the required notice to place the four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-in schedule I on a temporary basis to the Assistant Secretary for Health of HHS (Assistant Secretary). ⁽⁷⁾ By letter dated April 10, 2026, the Assistant Secretary responded to this notice and advised that, based on a review by the Food and Drug Administration (FDA), there were currently no investigational new drug applications or approved new drug applications for 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine. The Assistant Secretary also stated that HHS had no objection to the temporary placement of these substances in schedule I of the CSA. These four synthetic opioids are not currently listed in any schedule under the CSA, and no exemptions or approvals under 21 U.S.C. 355 are in effect for these substances.

DEA has taken into consideration the Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). DEA has found the control of the four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety.

As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of intent in the Federal Register on July 1, 2026, to temporarily schedule 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine. ⁽⁸⁾ That notice discussed findings from DEA's three-factor analysis, which DEA made available in its entirety under "Supporting and Related Material" of the public docket for this action at www.regulations.gov under Docket Number DEA-1665.

To find that temporarily placing a substance in schedule I of the CSA is necessary to avoid an imminent hazard to public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811(c): the substance's history and current pattern of abuse; the scope, duration, and significance of abuse; and what, if any, risk there is to public health. ⁽⁹⁾ This consideration includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of these substances. ⁽¹⁰⁾

Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. ⁽¹¹⁾ Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, ⁽¹²⁾ and a lack of accepted safety for use under medical supervision. ⁽¹³⁾

Four Synthetic Opioids: 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine

The ongoing evolution and availability of novel psychoactive substances on the illicit drug market continues to pose an imminent hazard to public safety. Adverse health effects associated with the abuse of these substances and their increased popularity have become a serious concern in recent years. Such substances include four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-which have been identified on the illicit drug market in the United States and worldwide.

These four synthetic opioids are pharmacologically similar to other synthetic opioids controlled under the CSA, such as brorphine, ⁽¹⁴⁾ fentanyl, ⁽¹⁵⁾ morphine, ⁽¹⁶⁾ and other mu-opioid receptor agonists. ⁽¹⁷⁾ Due to these pharmacological similarities, the use of these four synthetic opioids presents a high risk of abuse and may negatively affect users and their communities.

These four synthetic opioids, which belong to a subset of opioids colloquially known as orphines, are increasingly prevalent on the recreational drug market and have been co-identified with other substances, such as fentanyl, posing a significant threat to public safety. This is particularly concerning, because the United States continues to experience a significant number of opioid-involved overdoses. The misuse and abuse of synthetic opioids, such as these four substances, have led to devastating consequences, including death. In the United States, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine have been identified in both drug seizures and toxicological cases, and 5,6-dichloro brorphine has been identified in drug material.

The positive identification of these four synthetic opioids in law enforcement seizures and toxicology reports indicates their availability for drug abuse purposes, which poses a serious concern to public safety. These substances have been detected through multiple avenues, including DEA's Toxicology Testing Program (DEA TOX), ⁽¹⁸⁾ DEA's National Forensic Laboratory Information System (NFLIS), ⁽¹⁹⁾ other internal DEA data collection systems, and the National Institute of Standards and Technology's Rapid Drug Analysis and Research (RaDAR) program, ⁽²⁰⁾ among others. Data from these programs indicate that these substances are found both alone or in combination with other substances, and users may not be aware of polysubstance presence. In addition, online discussions surrounding the recreational use of these substances have recently increased. ⁽²¹⁾

To confront these emerging substances and avoid an imminent hazard to public safety, DEA intends to temporarily place 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine in schedule I of the CSA. Available data and information on these four synthetic opioids, summarized below, indicate that these substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. DEA's three-factor analysis is available in its entirety under "Supporting and Related Material" of the public docket for this action at www.regulations.gov under Docket Number DEA-1665.

Factor 4. Its History and Current Pattern of Abuse

5,6-Dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine are novel synthetic opioids that belong to a class of opioids colloquially known as orphines. The earliest known description of these substances, which include benzimidazolinyl piperidine derivatives ( i.e., benzimidazolones), appeared in a U.S. patent in 1967. ⁽²²⁾ In recent years, online forum users have begun to discuss recreational use of these four synthetic opioids and commonly compared these four synthetic opioids to other traditionally abused opioids, such as morphine and fentanyl (schedule II substances). However, unlike these two drugs that have FDA approval for use in specific medical treatments, the four synthetic opioids have no currently approved medical use and, based on positive identifications of these four substances in forensic drug exhibits and toxicology samples, are likely to be trafficked and abused similarly to other synthetic opioids, such as brorphine (schedule I).

Based on available data from user reports and law enforcement seizures, individuals purchase 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine primarily in powder form; additional forms include capsule, liquid, paste, rock, and tablet forms. Common routes of administration include oral consumption, inhalation (including vaping), and injection. Data also indicate that these four substances are likely co-ingested with other substances, whether as separate products or a single product containing multiple licit and illicit substances ( see Factor 6).

Factor 5. The Scope, Duration, and Significance of Abuse

Users on online forums began to discuss the four synthetic opioids and their consumption in recent years. In 2025, clusters of overdoses specifically resulting from N -propionitrile chlorphine use have led to public concern both in the United States and in other countries. This concern has initiated state-level efforts to control N -propionitrile chlorphine. ⁽²³⁾

In addition, law enforcement data indicate that the presence of the four synthetic opioids is increasingly widespread in the United States. NFLIS-Drug, a component of NFLIS, registered a collective total of 265 reports, across 21 states, pertaining to the trafficking, distribution, and abuse of the four synthetic opioids. ⁽²⁴⁾ More specifically, NFLIS-Drug reported 2 total encounters of 5,6-dichloro brorphine in 2 states since 2025; 2 total encounters of 5,6-dichloro desmethylchlorphine in 2 states since 2025; 225 total encounters of N -propionitrile chlorphine in 19 states since 2022; and 36 total encounters of spirochlorphine in 6 states since 2025. These states include Alabama, Arkansas, California, Connecticut, Florida, Iowa, Illinois, Louisiana, Massachusetts, Missouri, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, and Texas. Moreover, other internal DEA data collection systems reported four additional encounters of N -propionitrile chlorphine in 2026. ⁽²⁵⁾

Furthermore, RaDAR has detected two of the four synthetic opioids thus far. RaDAR reported its first detection of N -propionitrile chlorphine in a sample from the East Coast of the United States, collected in January 2026, that contained fentanyl, local anesthetics, medetomidine, and xylazine. ⁽²⁶⁾ RaDAR also reported its first detection of 5,6-dichloro desmethylchlorphine in multiple West Coast samples, collected in February 2026, that contained either cannabinoids and methamphetamine or no other compounds. ⁽²⁷⁾

Factor 6. What, if Any, Risk There Is to Public Health

The availability of synthetic opioids on the illicit drug market continues to exacerbate the opioid overdose epidemic and pose risks to public health and safety. As mentioned previously, 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine exhibit pharmacological profiles similar to those of fentanyl, morphine, and other mu-opioid receptor agonists. These substances bind to and activate the mu-opioid receptor, which then mediates various physiological responses, including reward-associated behavior.

Based on the pharmacological similarities between the four synthetic opioids and other mu-opioid agonists, the four synthetic opioids are likely to exhibit similar physiological responses. Available data on 5,6-dichloro brorphine and 5,6-dichloro desmethylchlorphine indicate that these two substances produce dose-dependent antinociception, reward-associated behavior, and physical dependence. ⁽²⁸⁾ Data on N -propionitrile chlorphine and spirochlorphine indicate that these two substances have greater receptor binding affinities, relative to fentanyl. ⁽²⁹⁾ Moreover, evidence suggests that users abuse the four synthetic opioids for their euphoric and analgesic effects. Users also specifically report self-administering 5,6-dichloro desmethylchlorphine to reduce or reset opioid tolerance in an attempt to continue or maximize drug-induced euphoric effects in subsequent sessions. Consequently, such an attempt may likely increase users' risk of inadvertent harm and fatal overdose during their next recreational dose of other drugs.

Toxicological and forensic case reports on these four synthetic opioids are currently limited, likely because commonly used drug screening methods may not yet be able to identify these four synthetic opioids. As a result, fatalities and emergency room admissions involving the four synthetic opioids, in addition to those reported below, have likely occurred without report. At present, only one nonfatal overdose related to the four synthetic opioids has been reported in scientific and medical literature. ⁽³⁰⁾ In this case report, authors reported that a 36-year-old man was found unconscious after inhaling a substance he believed to be alprazolam-a prescription benzodiazepine-which forensic analysis revealed was primarily N -propionitrile chlorphine mixed with fentanyl and xylazine. The overdose victim also exhibited bradycardia and hypothermia upon arrival at the emergency department.

Despite the limited case reports for these substances in literature, case reports may be obtained through other programs, such as DEA TOX. DEA TOX provides expanded analysis to detect novel psychoactive substances in samples for which routine toxicological findings do not explain the toxidrome exhibited by the victim. Thus far, DEA TOX has positively identified N -propionitrile chlorphine in a total of 49 fatalities; victims included both male (n = 28) and female (n = 21) users, with ages ranging from 18-66 years old. ⁽³¹⁾ In five of these cases, N -propionitrile chlorphine was detected at low levels, either alone or in the presence of other substances at negligible concentrations, illustrating the potential harm of even low doses of this substance.

Moreover, law enforcement and harm reduction data indicate that the four synthetic opioids are easily and affordably obtainable online and on the illicit market. Available law enforcement data reveal that drug seizures related to the four synthetic opioids contain a plethora of co-identified substances; these substances include, but are not limited to, other opioids ( e.g., carfentanil (schedule II), chlorphine, fentanyl (schedule II), N -pyrrolidino metonitazene (schedule I)); benzodiazepines ( e.g., alprazolam (schedule IV), bromazolam (schedule I), clonazolam (schedule I)); stimulants ( e.g., cocaine (schedule II), methamphetamine (schedule II)); hallucinogens ( e.g., phencyclidine (schedule II)); pharmaceuticals ( e.g., diphenhydramine, quetiapine); and other adulterants ( e.g., xylazine, bis(2,2,6,6-tetramethyl-4-piperidyl)sebacate). Available harm reduction data indicate that the four synthetic opioids were individually or combinedly present as major substances or trace contaminants in samples assumed to be other drugs, like fentanyl. Consequently, individuals may be unknowingly exposed to these substances despite their intentions to consume other drugs, such as fentanyl.

Congruent with the data above, toxicological reports suggest that users may have inadvertently ingested the four synthetic opioids with other drugs, whether as separate products or a single product containing multiple licit and illicit substances. In available toxicological reports through DEA TOX, substances co-identified with N -propionitrile chlorphine include, but are not limited to, benzodiazepines ( e.g., bromazolam (schedule I)); other opioids ( e.g., fentanyl (schedule II), metonitazene (schedule I), morphine (schedule II)); stimulants ( e.g., cocaine (schedule II), methamphetamine (schedule II)); and other adulterants ( e.g., medetomidine, xylazine). Furthermore, the Center for Forensic Science Research and Education reported detecting the four synthetic opioids alone, with each other, or in combination with other synthetic opioids ( e.g., chlorphine, fentanyl (schedule II), N -pyrrolidino ethylene isotonitazene); designer benzodiazepines ( e.g., phenazolam); and synthetic cathinones ( e.g., 3,4-methylenedioxy-alpha-pyrrolidinoisohexanophenone) across toxicological and drug samples submitted to its program for analysis. ⁽³²⁾

In summary, the data presented above indicate that these four synthetic opioids have been encountered as single substances and as polysubstance combinations, and, as a result, the unpredictable levels of adulterant or drug purity across samples poses significant harm and unintended consequences to public health, including death.

Finding of Necessity of Schedule I Placement To Avoid Imminent Hazard To Public Safety

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine pose imminent hazards to public safety. DEA is not aware of any currently accepted medical uses for 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine in treatment in the United States. A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I must have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine indicate that these substances meet the three statutory criteria.

As required by 21 U.S.C. 811(h)(4), the Administrator notified the Assistant Secretary via letter dated April 1, 2026, of DEA's intention to temporarily place four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-in schedule I. In a letter dated April 10, 2026, the Assistant Secretary had no objection to the temporary placement of these four substances in schedule I. DEA subsequently published a notice in the Federal Register on July 1, 2026.

Conclusion

In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule the four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-in schedule I of the CSA, and finds that placement of these substances in schedule I is necessary to avoid an imminent hazard to the public's safety.

The temporary placement of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine in schedule I of the CSA will take effect on the date the order is published in the Federal Register and will remain in effect for two years, with a possible extension of an additional year, pending completion of the regular (permanent) scheduling process. ⁽³³⁾

The CSA sets forth specific criteria for scheduling drugs or other substances. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures "on the record after opportunity for a hearing" conducted pursuant to the provisions of 5 U.S.C. 556 and 557. ⁽³⁴⁾ The regular scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. ⁽³⁵⁾ Temporary scheduling orders are not subject to judicial review. ⁽³⁶⁾

Requirements for Handling

Upon the effective date of this temporary order, 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, possession of, and engagement in research and conduct of instructional activities or chemical analysis with, schedule I controlled substances, including but not limited to the following:

1. Registration. Any person who handles (possesses, manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with) or desires to handle 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine must be registered with DEA to conduct such activities, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312, as of August 27, 2026. Any person who currently handles 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine and is not registered with DEA must submit an application for registration and may not continue to handle 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine as of August 27, 2026, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on August 27, 2026, a person is conducting research on 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine and is already registered to conduct research with another controlled substance in schedule I, the person may continue to conduct research on 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine if they submit a completed application for registration or modification of existing registration, as applicable, to conduct research with 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine not later than 90 calendar days after August 27, 2026. The person may continue to conduct such research until the person withdraws the application or the Administrator serves on the person an order to show cause proposing denial of the application pursuant to 21 U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If the Administrator serves an order to show cause proposing denial of the application or modification, the person may not continue to conduct research with 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine and may not receive or otherwise obtain additional 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine. If an order to show cause is served and the person requests a hearing in accordance with 21 CFR 1301.37(d), the hearing shall be held in accordance with 21 CFR 1301.41-1301.46 on an expedited basis and not later than 45 calendar days after the request is made, except that the hearing may be held at a later time if so requested by the person. If the person sends a copy of the application to a manufacturer or distributor of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine, receipt of the copy by the manufacturer or distributor constitutes sufficient evidence that the person is authorized to receive 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine pursuant to 21 U.S.C. 822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not authorize any other handling ( e.g., distribution) of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine.

Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine in a manner not authorized by the CSA on or after August 27, 2026, is unlawful, and those in possession of any quantity of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine may be subject to prosecution pursuant to the CSA.

2. Disposal of stocks. Any person who does not desire or is unable to obtain a schedule I registration to handle 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine must surrender all currently held quantities of these substances.

3. Security. 5,6-Dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine is subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71-1301.93, as of August 27, 2026.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine must comply with 21 U.S.C. 825 and 958(e) and 21 CFR part 1302. Current DEA registrants will have 30 calendar days from August 27, 2026, to comply with all labeling and packaging requirements.

5. Inventory. Every DEA registrant who possesses any quantity of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine on the effective date of this order must take an inventory of all stocks of these substances on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants will have 30 calendar days from the effective date of this order to comply with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine) on hand on a biennial basis pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records. All DEA registrants must maintain records with respect to 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine pursuant to 21 U.S.C. 827 and 958(e) and in accordance with 21 CFR parts 1304, 1312, and 1317, and section 1307.11. Current DEA registrants authorized to handle 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine shall have 30 calendar days from the effective date of this order to comply with all recordkeeping requirements.

7. Reports. All DEA registrants must submit reports with respect to 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1312, and 1317, and sections 1301.74(c) and 1301.76(b), as of August 27, 2026. Manufacturers and distributors must also submit reports regarding 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.

8. Order Forms. All DEA registrants who distribute 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of August 27, 2026.

9. Importation and Exportation. All importation and exportation of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312 as of August 27, 2026.

10. Quota. Generally, only DEA-registered manufacturers may manufacture 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303, as of August 27, 2026.

11. Liability. Any activity involving 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine not authorized by or in violation of the CSA, occurring as of August 27, 2026, is unlawful, and may subject the person to administrative, civil, or criminal sanctions.

Regulatory Analyses

The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to public safety. Under 21 U.S.C. 811(h)(1), the Administrator (as delegated by the Attorney General) may, by order, temporarily place substances in schedule I. Such orders may not be issued before the expiration of 30 days from: (1) the publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary, as delegated by the Secretary of HHS. ⁽³⁷⁾

Inasmuch as section 811(h) directs that temporary scheduling actions be issued by order (as distinct from a rule) and sets forth the procedures by which such orders are to be issued, DEA believes the notice-and-comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, which are applicable to rulemaking, do not apply to this temporary scheduling order. The APA expressly differentiates between orders and rules, as it defines an "order" to mean a "final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making. "  ⁽³⁸⁾ This contrasts with permanent scheduling actions, which are subject to formal rulemaking procedures done "on the record after opportunity for a hearing," and final decisions that conclude the scheduling process and are subject to judicial review. ⁽³⁹⁾ The specific language chosen by Congress indicates its intent that DEA issue orders instead of proceeding by rulemaking when temporarily scheduling substances. Given that Congress specifically requires the Administrator (as delegated by the Attorney General) to follow rulemaking procedures for other kinds of scheduling actions, ⁽⁴⁰⁾ it is noteworthy that, in section 811(h)(1), Congress authorized the issuance of temporary scheduling actions by order rather than by rule.

Even assuming that this action is subject to the notice-and-comment requirements of the APA, the Administrator finds that there is good cause to forgo these requirements pursuant to 5 U.S.C. 553(b)(B), as any further delays in the process for issuing temporary scheduling orders would be impracticable and contrary to the public interest given the manifest urgency to avoid an imminent hazard to public safety.

Although DEA believes this temporary scheduling order is not subject to the notice-and-comment requirements of the APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator took into consideration comments submitted by the Assistant Secretary in response to the notices that DEA transmitted to the Assistant Secretary pursuant to such subsection.

Further, DEA believes that this temporary scheduling action is not a "rule" as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. Therefore, in this instance, since DEA believes this temporary scheduling action is not a "rule," it is not subject to the requirements of the RFA when issuing this temporary action.

In accordance with the principles of Executive Orders (E.O.) 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. The Office of Management and Budget has determined that this is not a significant regulatory action as defined in Section 3(f) of E.O. 12866. In addition, DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.

This action will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 13132, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

PART 1308-SCHEDULES OF CONTROLLED SUBSTANCES

Signing Authority

This document of the Drug Enforcement Administration was signed on August 23, 2026, by DEA Administrator Terrance C. 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 .

[FR Doc. 2026-17531 Filed 8-26-26; 8:45 am]

BILLING CODE 4410-09-P

⁽¹⁾  Though DEA has used the term "final order" with respect to temporary scheduling orders in the past, this action adheres to the statutory language of 21 U.S.C. 811(h), which refers to a "temporary scheduling order." No substantive change is intended.

⁽²⁾  21 U.S.C. 811(h)(1).

⁽³⁾  21 U.S.C. 811(h)(2).

⁽⁴⁾  21 U.S.C. 811(h)(1); 21 CFR part 1308.

⁽⁵⁾  28 CFR 0.100.

⁽⁶⁾  21 U.S.C. 811(h)(4).

⁽⁷⁾  The Secretary of HHS has delegated to the Assistant Secretary for Health of HHS the authority to make domestic drug scheduling recommendations. Comprehensive Drug Abuse Prevention and Control Act of 1970, Public Law 91-513, As Amended; Delegation of Authority, 58 FR 35460 (July 1, 1993).

⁽⁸⁾ Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act, 91 FR 39940 (July 01, 2026).

⁽⁹⁾  21 U.S.C. 811(c)(4)-(6), (h)(3).

⁽¹⁰⁾  21 U.S.C. 811(h)(3).

⁽¹¹⁾  21 U.S.C. 811(h)(1).

⁽¹²⁾  When finding schedule I placement on a temporary basis is necessary to avoid imminent hazard to the public, 21 U.S.C 811(h) does not require DEA to consider whether the substance has a currently accepted medical use in treatment in the United States. Nonetheless, there is no evidence suggesting that the four synthetic opioids-5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine-have a currently accepted medical use in treatment in the United States. First, DEA looks to whether the drug or substance has FDA approval for marketing in interstate commerce. When no FDA approval exists, DEA has traditionally applied a five-part test to determine whether a drug or substance has a currently accepted medical use: (1) the drug's chemistry must be known and reproducible; (2) there must be adequate safety studies; (3) there must be adequate and well-controlled studies proving efficacy; (4) the drug must be accepted by qualified experts; and (5) the scientific evidence must be widely available. See Marijuana Scheduling Petition; Denial of Petition; Remand, 57 FR 10499 (Mar. 26, 1992), pet. for rev. denied, Alliance for Cannabis Therapeutics v. Drug Enforcement Admin., 15 F.3d 1131, 1135 (D.C. Cir. 1994). DEA applied the traditional five-part test and concluded the test was not satisfied. In a published letter in a different context, HHS created and applied its own two-part test to determine currently accepted medical use for substances that do not satisfy the five-part test: (1) whether there exists widespread, current experience with medical use of the substance by licensed health care providers operating in accordance with implemented jurisdiction-authorized programs, where medical use is recognized by entities that regulate the practice of medicine, and, if so, (2) whether there exists some credible scientific support for at least one of the medical conditions for which part (1) is satisfied. On April 11, 2024, the Department of Justice's Office of Legal Counsel (OLC) issued an opinion, which, among other things, concluded that HHS's two-part test would be sufficient to establish that a drug has a currently accepted medical use. Office of Legal Counsel, Memorandum for Merrick B. Garland Attorney General Re: Questions Related to the Potential Rescheduling of Marijuana at 3 (April 11, 2024). For purposes of this notice of intent, there is no evidence that health care providers have widespread experience with medical use of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine, or that the use of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine is recognized by entities that regulate the practice of medicine, so the two-part test also is not satisfied. By letter dated April 10, 2026, HHS advised DEA that there are currently no approved new drug applications or investigational new drug applications for 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, or spirochlorphine. In addition, HHS communicated no objections to the temporary placement of 5,6-dichloro brorphine, 5,6-dichloro desmethylchlorphine, N -propionitrile chlorphine, and spirochlorphine into schedule I of the CSA.

⁽¹³⁾  21 U.S.C. 812(b)(1).

⁽¹⁴⁾  21 CFR 1308.11(b)(24).

⁽¹⁵⁾  21 CFR 1308.12(c)(9).

⁽¹⁶⁾  21 CFR 1308.12(b)(1)(ix).

⁽¹⁷⁾  Unpublished data obtained for DEA by the U.S. Department of Veterans Affairs (VA), via a DEA-VA Interagency Agreement, titled "In Vitro Receptor and Transporter Assays for Abuse Liability Testing for the DEA by the VA."

⁽¹⁸⁾  DEA TOX is a surveillance program that aims to detect novel psychoactive substances (NPS) in fatal and nonfatal overdose cases within the United States. From these cases, biological samples, as well as drug paraphernalia (on limited occasions), are submitted for analysis by hospitals, medical examiners, poison centers, and law enforcement nationwide.

⁽¹⁹⁾  NFLIS represents an important resource in monitoring illicit drug trafficking, including the diversion of legally manufactured pharmaceuticals into illegal markets. NFLIS-Drug is a comprehensive information system that includes data from forensic laboratories that handle more than 96 percent of an estimated 1 million distinct annual federal, state, and local drug analysis cases. NFLIS-Drug includes drug chemistry results from completed analyses only. While NFLIS-Drug data are not direct evidence of abuse, these can lead to an inference that a drug has been diverted and abused. See Schedules of Controlled Substances: Placement of Carisoprodol Into Schedule IV, 76 FR 77330, 77332 (Dec. 12, 2011).

⁽²⁰⁾  RaDAR seeks to elucidate the chemical compositions of drugs throughout the illicit drug landscape. Additional information is available at https://www.nist.gov/programs-projects/radar.

⁽²¹⁾  Based on forum searches for the four synthetic opioids. In addition, the National Drug Early Warning System (NDEWS) provides Weekly Briefing newsletters related to drug trends, including web monitoring. N -Propionitrile Chlorphine was featured in Issue 201: September 27, 2024. SR-17018 was featured in Issue 257: November 14, 2025. Last accessed March 17, 2026. Newsletters are available at https://ndews.org/publications/ndews-weekly-briefings/.

⁽²²⁾ See Janssen, P.A.J. (1967). Derivatives of benzimidazolinyl piperidine (U.S. Patent No. 3,318,900). U.S. Patent and Trademark Office.

⁽²³⁾  For example, a bill was recently introduced in the General Assembly of Kentucky to, among other things, control cychlorphine. See Ky. Gen. Assemb., H.B. 750, Reg. Sess. (2026), available at https://apps.legislature.ky.gov/record/26rs/hb750.html.

⁽²⁴⁾  NFLIS-Drug data were queried on May 18, 2026. NFLIS-Drug reports are still pending for 2025 and 2026 due to normal lag time.

⁽²⁵⁾  The internal DEA data collection system was queried on May 21, 2026.

⁽²⁶⁾  Rapid Drug Analysis and Research (RaDAR). (2026, February 15). RaDAR Newsletter-January 2026. U.S. Department of Commerce, National Institute of Standards and Technology. https://content.govdelivery.com/accounts/USNIST/bulletins/4093681.

⁽²⁷⁾  Rapid Drug Analysis and Research (RaDAR). (2026, March 16). RaDAR Newsletter-February 2026. U.S. Department of Commerce, National Institute of Standards and Technology. https://content.govdelivery.com/accounts/USNIST/bulletins/40e2fe7.

⁽²⁸⁾ See Kudla, L., Bugno, R., Podlewska, S., Szumiec, L., Wiktorowska, L., Bojarski, A.J., & Przewlocki, R. (2021). Comparison of an addictive potential of μ-opioid receptor agonists with G protein bias: Behavioral and molecular modeling studies. Pharmaceutics, 14 (1), 55. https://doi.org/10.3390/pharmaceutics14010055.

⁽²⁹⁾  Unpublished data obtained for DEA by the U.S. Department of Veterans Affairs (VA), via a DEA-VA Interagency Agreement, titled "In Vitro Receptor and Transporter Assays for Abuse Liability Testing for the DEA by the VA."

⁽³⁰⁾ See Sprague, J.E., Toms, J.A., & Ratermann, C.F. (2025). Non-fatal opioid overdose associated predominantly with the benzimidazolone, cychlorphine. Clinical toxicology (Philadelphia, Pa.), 1-2. Advance online publication. https://doi.org/10.1080/15563650.2025.2594070.

⁽³¹⁾  DEA TOX data include confirmed detections of NPS through the data query date, May 18, 2026.

⁽³²⁾  The Center for Forensic Science Research and Education documents its findings of novel psychoactive substances through drug monographs published on its website. Available at https://www.cfsre.org/nps-discovery/monographs.

⁽³³⁾  21 U.S.C. 811(h)(1) and (2).

⁽³⁴⁾  21 U.S.C. 811.

⁽³⁵⁾  21 U.S.C. 877.

⁽³⁶⁾  21 U.S.C. 811(h)(6).

⁽³⁷⁾  21 U.S.C. 811(h)(1).

⁽³⁸⁾  5 U.S.C. 551(6) (emphasis added).

⁽³⁹⁾  21 U.S.C. 811(a) and 877.

⁽⁴⁰⁾ See 21 U.S.C. 811(a).