[Federal Register Volume 91, Number 154 (Wednesday, August 12, 2026)]
[Rules and Regulations]
[Pages 52013-52018]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-16413]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-1641]
Schedules of Controlled Substances: Temporary Placement of O-
Desmethyltramadol in Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Temporary amendment; temporary scheduling order.
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SUMMARY: The Drug Enforcement Administration issues this temporary
order to schedule O-desmethyltramadol (other names: O-DSMT;
desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1-
hydroxycyclohexyl]phenol), including its isomers, esters, ethers,
salts, and salts of isomers, esters and ethers, in schedule I of the
Controlled Substances Act. DEA bases this action on a finding that
placing O-DSMT in schedule I is necessary to avoid an imminent hazard
to public safety. This order imposes the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical analysis with, or possess) or
propose to handle O-DSMT.
DATES: This temporary order is effective August 12, 2026, until August
12, 2028. If this order is extended or made permanent, DEA will publish
a document in the Federal Register.
ADDRESSES: 8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION: The Drug Enforcement Administration (DEA)
issues a temporary scheduling order \1\ (in the form of a temporary
amendment) to add O-desmethyltramadol (other names: 3-(2-
((dimethylamino)methyl)-1-hydroxycyclohexyl)phenol; O-DSMT;
desmetramadol), its isomers, esters, ethers, salts, and salts of
isomers, esters, and ethers, to schedule I under the Controlled
Substances Act (CSA).
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\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.
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Legal Authority
The CSA provides the Attorney General (as delegated to the
Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) 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\
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\2\ 21 U.S.C. 811(h)(1).
\3\ 21 U.S.C. 811(h)(2).
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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\
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\4\ 21 U.S.C. 811(h)(1); 21 CFR part 1308.
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Background
The CSA requires the Administrator of DEA (Administrator) to notify
the Secretary 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).\5\ By letter dated May 27, 2025, the
previous Acting Administrator transmitted the required notice to place
O-DSMT in schedule I on a temporary basis to the then-Acting Assistant
Secretary for HHS (Assistant Secretary).\6\ On June 11, 2025, the
previous Acting Assistant Secretary responded to this notice and
advised DEA that, based on a review by the Food and Drug Administration
(FDA), there were currently no investigational new drug applications
(INDs) or approved new drug applications (NDAs) for O-DSMT. The
previous Assistant Secretary also stated that HHS had no objection to
the temporary placement of O-DSMT in schedule I of the CSA. O-DSMT is
not currently listed in any schedule under the CSA.
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\5\ 21 U.S.C. 811(h)(4).
\6\ 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).
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DEA has taken into consideration the Acting Assistant Secretary's
comments as required by 21 U.S.C. 811(h)(4). DEA has found the control
of O-DSMT in schedule I on a temporary basis is necessary to avoid an
imminent hazard to public safety.
To find that temporarily placing a substance in schedule I of the
CSA is necessary to avoid an imminent hazard to the 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 the public health.\7\ Consideration of these factors
includes any information indicating actual abuse, diversion from
legitimate channels, and clandestine importation, manufacture, or
distribution of O-DSMT.\8\
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\7\ 21 U.S.C. 811(c)(4)-6), (h)(3).
\8\ 21 U.S.C. 811(h)(3).
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Substances meeting the statutory requirements for temporary
scheduling may only be placed in schedule I.\9\ Substances in schedule
I have high potential for abuse, no currently accepted medical use in
treatment in the United States, and a lack of accepted safety for use
of the drug under medical supervision.\10\
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\9\ 21 U.S.C. 811(h)(1).
\10\ 21 U.S.C. 812(b)(1).
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As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of
intent (NOI) to temporarily schedule O-DSMT in the Federal Register on
June 24, 2026.\11\ That NOI discussed findings from DEA's Three-factor
analysis dated May 2026, which DEA made available on
www.regulations.gov.
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\11\ Schedules of Controlled Substances: Temporary Placement of
O-DSMT in Schedule I, 91 FR 37822 (June 24, 2026).
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O-Desmethyltramadol (O-DSMT)
O-DSMT is a mu-opioid agonist that is being abused for its
psychoactive effects. O-DSMT is one of two metabolites produced by
liver enzymes following the ingestion of the parent compound tramadol.
Tramadol is active as a norepinephrine and serotonergic reuptake
inhibitor, in addition to being a weak mu-opioid receptor agonist. O-
DSMT is an active metabolite of tramadol with a strong affinity for the
mu-opioid receptor and is responsible for the majority of the
opioidergic
[[Page 52014]]
effects following the ingestion of tramadol.
In the United States, since tramadol is only approved as a pill
formulation, a user must ingest tramadol orally, thus allowing the drug
to be metabolized via the liver, to experience the analgesic effects.
In the absence of any approved medical product or identified lawful
commercial source of O-DSMT in the United States, understanding the
metabolism of tramadol and its opioidergic metabolite O-DSMT has
resulted in the clandestine production of O-DSMT. Data has demonstrated
that O-DSMT has a significantly higher affinity for opioid receptors
(Ki-3.4 nM) than the parent drug tramadol (Ki-
2400 nM) and is more potent in producing analgesia. In addition,
overdoses and deaths, both internationally and within the United
States, have been documented involving O-DSMT. With no approved medical
use and limited safety or toxicological information, O-DSMT has emerged
in the designer drug market, and the abuse of this substance is a
significant public health concern in the United States.
Available data and information for O-DSMT, summarized below,
indicate that this substance has a 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. 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-1641.
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\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 O-DSMT has 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 substances 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 recent published
letter in a different context, HHS applied an additional 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 O-DSMT or that the use of O-DSMT is recognized by
entities that regulate the practice of medicine, so the two-part
test also is not satisfied. By letter dated June 11, 2025, DEA has
been advised by HHS that there are currently no approved new drug
applications or investigational new drug applications for O-DSMT.
Additionally, HHS communicated no objections to the temporary
placement of O-DSMT into Schedule I of the CSA.
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Factor 4. Its History and Current Pattern of Abuse
As described previously, O-DSMT is a major metabolite of tramadol.
O-Demethylation of the parent drug tramadol results in the formation of
O-DSMT, which is primarily catalyzed by the cytochrome P450 liver
enzyme 2D6 (CYP2D6). Individuals of various backgrounds have been
identified as either ultrarapid metabolizers, normal metabolizers,
intermediate metabolizers, or poor metabolizers of tramadol based upon
genotyping of CYP2D6. The current Clinical Pharmacogenetics
Implementation Consortium guidelines recommend avoiding tramadol in
CYP2D6 ultrarapid metabolizers (due to possible toxicity from increased
formation of O-DSMT) and CYP2D6 poor metabolizers (due to possible lack
of efficacy from decreased formation of O-DSMT). Ultrarapid
metabolizers have approximately 40 percent greater serum concentration
of O-DSMT and subsequently experience a stronger opioid response
compared with poor metabolizers.
O-DSMT has been encountered in various forms, including as a solid
powder, pressed into pills or tablets, in a capsule, as a semi-solid
paste/slurry, and in liquid formulations. Direct ingestion of O-DSMT
avoids the need for metabolic activation via liver enzymes, resulting
in a compound that is pharmacologically active at the mu-opioid
receptor. Injection or insufflation by drug abusers of tramadol would
be devoid of most immediate opioid activity due to the parent compound
having little affinity for the opioid receptors. As further described
in Factor 5, drug seizures have demonstrated O-DSMT both alone and in
combination with multiple other drugs. In a randomized, double-blind,
placebo and active comparator-controlled trial, the pharmacokinetics
and analgesic properties of O-DSMT, as compared to tramadol, in 103
healthy participants were investigated. The study also investigated
CYP2D6 inhibition on the ability of both tramadol and O-DSMT to
influence analgesia. The results showed that 20 mg of O-DSMT was
equivalent in its analgesic potency as compared to 50 mg of tramadol
following chronic dosing at steady state, whereby both were
significantly greater than placebo (see Three-Factor analysis).
Factor 5. The Scope, Duration, and Significance of Abuse
With the first encounters appearing in 2011, law enforcement
continues to report seizures of O-DSMT. The threat of serious injury to
the individual and the imminent threat to public safety following the
ingestion of O-DSMT persists. DEA's National Forensic Laboratory
Information System (NFLIS) \13\ has reported 147 encounters of O-DSMT
across 30 states.\14\ Because not every forensic laboratory has the
capacity to test for O-DSMT, it is likely that these encounters are
underreported.
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\13\ NFLIS is a national forensic laboratory reporting system
that systematically collects results from drug chemistry analyses
conducted by state, local, and federal forensic laboratories in the
United States. NFLIS represents an important resource in monitoring
illicit drug trafficking, including the diversion of legally
manufactured pharmaceuticals into illegal markets. NFLIS is a
comprehensive information system that includes data from forensic
laboratories that handle more than 96 percent of an estimated 1.0
million distinct annual State and local drug analysis cases. NFLIS
includes drug chemistry results from completed analyses only. While
NFLIS data is not direct evidence of abuse, it 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).
\14\ NFLIS query date: May 11, 2026; 2025 and 2026 data are
still being reported.
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O-DSMT has been encountered in various forms, including as a solid
powder, pressed into pills or tablets, in a capsule, as a semi-solid
paste/slurry, and in liquid formulations. Among these various reports,
O-DSMT has been found as the only drug in a majority of these
encounters (n=118 of 147, 80.2 percent), or mixed with various other
substances to include mitragynine (kratom alkaloid), heroin, isopropyl-
U-47700 (synthetic opioid), methamphetamine, fentanyl, acetyl fentanyl,
5F-AEB (synthetic cannabinoid), methoxyacetyl fentanyl, N-
benzylfuranylfentanyl, 3-OH-PCE (synthetic hallucinogen), tramadol,
bromazolam (designer benzodiazepine), para-fluorofentanyl, dipentylone
(synthetic cathinone), and/or cocaine, among others. O-DSMT has also
been identified in conjunction with other
[[Page 52015]]
substances, as evidenced by toxicology reports (see Factor 6). O-DSMT
was found to be mixed with the kratom plant as determined by testing of
the packaging material and the confirmation of both O-DSMT and
mitragynine in toxicology results of individuals.
Factor 6. What, if Any, Risk There Is to the Public Health
Public health risks associated with O-DSMT abuse relates to its
pharmacological similarities with known opioids such as morphine,
oxycodone, and fentanyl. The ingestion of O-DSMT has resulted in
serious adverse effects including lung congestion, brain edema, and
death. The following four examples discussed briefly below can be found
in their entirety in DEA's Three-factor analysis at www.regulations.gov
under Docket Number DEA-1641.
In 2009, reports in Sweden described nine deaths due to
intoxication with O-DSMT combined with mitragynine and confirmed via
forensic autopsies. Occurring between October 2009 and October 2010,
ten forensic medical investigations found concomitant use of O-DSMT and
mitragynine in the blood of these deceased individuals. It was noted
that in nine of these cases, the death was explained by intoxication
with O-DSMT. Other substances were identified, but it was stated that
these substances were not at toxic levels. Ages of the individuals
ranged between 22-35 years old, concentrations of O-DSMT ranged between
0.4 and 4.3 [micro]g/g in blood, and all the individuals died before
arriving at a hospital. Deaths for all individuals were noted to be
accidental. Additional information in the reports detailed significant
lung congestion and edema following use of ``Krypton'' (a mix of kratom
and O-DSMT).
Around the same time as the deaths were reported in Sweden, a group
in Germany in 2010 were asked to analyze urine samples for ``Krypton''
in a former opiate-addicted woman. The woman's clinical picture
included miosis, itchiness, agitation, and moderate euphoria following
three months of use. Both immunoassays and liquid chromatography-tandem
mass spectrometry (LC-MS/MS) were conducted on the samples. Results
were negative for tramadol or its metabolites using the immunoassays.
LC-MS/MS detected the kratom alkaloids mitragynine, speciociliatine,
speciogynine, mitraciliatine, and paynantheine and approximately 9 mg/L
O-DSMT, but no tramadol nor N-desmethyltramadol. Once confronted with
these results, the woman admitted to having drunk ``3-4 infusions of
Krypton'' during the past week. The researchers ruled out the use of
tramadol because both tramadol and N-desmethyltramadol were not
detectable. It was concluded that the most likely source of the O-DSMT
was the ``Krypton'' product, containing both kratom alkaloids and O-
DSMT.
In 2021 in Portugal, a 25-year-old male was found dead in his room
at a boarding house where he lived. He was a chemistry student who,
according to relatives, was ``trying to find a cure to his illness
using chemical products bought by himself.'' Drug paraphernalia found
at the scene included a spoon, a syringe, and six different plastic
bags found with powders inside. It was noted that all six bags were
labeled with the supposed name of the compounds. Further testing
confirmed that the labels were accurate for each substance, including
O-DSMT. His past medical history included schizophrenia and bipolar
disorder. In addition, needle puncture marks in the victim's arms,
indicative of drug abuse, were noted during autopsy.
In 2021 in Kansas City, Kansas, a 19-year-old male with a history
of anxiety and depression was last observed by a roommate lying on his
bed and reported to be ``snoring and sweaty.'' The autopsy did not
reveal any significant anatomical abnormalities. Drug evidence at the
scene was noted to be labeled as clonazolam, flubromazolam, O-
desmethyltramadol (O-DSMT), and 2-methyl-AP-237. Toxicological analysis
of whole blood from autopsy identified the following: 2-methyl AP-237
(379 ng/mL), detla-9 THC (56.8 ng/mL), 11-nor-9-carboxy-delta-9-THC
(141 ng/mL), 8-aminoclonazolam (4.6 ng/mL), O-DSMT (10.9 ng/mL), and
mitragynine (2.7 ng/mL). 7-Amino clonazepam, diphenhydramine,
fluoxetine, norfluoxetine, trazodone, and propranolol were also
identified but not quantified.
As noted in Factor 5, counterfeit pills pressed to resemble
tramadol may contain O-DSMT either alone or in combination with other
substances. Clandestine manufacturers will commonly use legitimate
markings when producing counterfeit pills. Should a user ingest a pill
marked as tramadol that was surreptitiously produced with O-DSMT, the
individual might experience serious adverse effects due to the stronger
analgesic potential of O-DSMT as compared to tramadol.
As users obtain these drugs through unknown sources, the identity
and purity of these substances is uncertain and inconsistent, thus
posing significant adverse health risks to users. O-DSMT is being
encountered on the illicit drug market in the United States, has no
accepted medical use in the United States, and continues to be
available and abused for its psychoactive properties. In summary, O-
DSMT has been reported to cause serious adverse effects, including
death, following its use.
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 O-DSMT
poses an imminent hazard to public safety. O-DSMT has not been approved
by the FDA and has not been marketed in the United States, and DEA is
not aware of any currently accepted medical uses for O-DSMT 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 O-DSMT indicate that
this substance meets the three statutory criteria.
As required by 21 U.S.C. 811(h)(4), in a letter dated May 27, 2025,
the previous Acting Administrator notified the previous Acting
Assistant Secretary of DEA's intention to temporarily place O-DSMT in
schedule I. In a letter dated June 11, 2025, the previous Acting
Assistant Secretary did not object to the temporary placement of O-DSMT
in schedule I. DEA subsequently published a NOI in the Federal Register
on June 24, 2026.\15\
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\15\ Schedules of Controlled Substances: Temporary Placement of
O-DSMT in Schedule I, 91 FR 37822 (June 24, 2026).
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Conclusion
In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator
considered available data and information, herein sets forth the
grounds for his determination that it is necessary to temporarily
schedule O-DSMT in schedule I of the CSA, and finds that placement of
this substance in schedule I is necessary to avoid an imminent hazard
to the public's safety.
The temporary placement of O-DSMT in schedule I of the CSA will
take effect on the date the order is published in the
[[Page 52016]]
Federal Register and will remain in effect for two years, with a
possible extension of one year, pending completion of the regular
(permanent) scheduling process.\16\
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\16\ 21 U.S.C. 811(h)(1) and (2).
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The CSA sets forth specific criteria for scheduling drugs or other
substances. Permanent 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.\17\ The permanent 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 permanent scheduling
process of formal rulemaking are subject to judicial review.\18\
Temporary scheduling orders are not subject to judicial review.\19\
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\17\ 21 U.S.C. 811.
\18\ 21 U.S.C. 877.
\19\ 21 U.S.C. 811(h)(6).
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Requirements for Handling
Upon the effective date of this temporary order, O-DSMT 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, O-DSMT 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 12,
2026. Any person who currently handles O-DSMT and is not registered
with DEA must submit an application for registration and may not
continue to handle O-DSMT as of August 12, 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 12, 2026, a person is conducting research on O-DSMT and is
already registered to conduct research with another controlled
substance in schedule I, the person may continue to conduct research on
O-DSMT if they submit a completed application for registration or
modification of existing registration, as applicable, to conduct
research with O-DSMT not later than 90 calendar days after August 12,
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 O-DSMT and may not receive or otherwise obtain additional
O-DSMT. 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 O-DSMT, receipt of the copy by the manufacturer or
distributor constitutes sufficient evidence that the person is
authorized to receive O-DSMT 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 O-DSMT.
Retail sales of schedule I controlled substances to the general
public are not allowed under the CSA. Possession of any quantity of O-
DSMT in a manner not authorized by the CSA on or after August 12, 2026
is unlawful, and those in possession of any quantity of O-DSMT 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 O-DSMT must surrender all
currently held quantities of this substance.
3. Security. O-DSMT is subject to schedule I security requirements
and must be handled in accordance with 21 CFR 1301.71-1301.93, as of
August 12, 2026.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of O-DSMT 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 12, 2026 to comply with all labeling and
packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of O-
DSMT on the effective date of this order must take an inventory of all
stocks of this substance 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 O-DSMT) 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 O-DSMT 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 O-DSMT 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
O-DSMT 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 12, 2026. Manufacturers and distributors must also submit
reports regarding O-DSMT 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 O-DSMT must
comply with order form requirements pursuant to 21 U.S.C. 828 and in
accordance with 21 CFR part 1305 as of August 12, 2026.
9. Importation and Exportation. All importation and exportation of
O-DSMT 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 12, 2026.
10. Quota. Only DEA-registered manufacturers may manufacture O-DSMT
in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in
accordance with 21 CFR part 1303, as of August 12, 2026.
11. Liability. Any activity involving O-DSMT not authorized by or
in violation of the CSA, occurring as of August 12, 2026, is unlawful,
and may subject the person to administrative, civil, and/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.
[[Page 52017]]
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.\20\
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\20\ 21 U.S.C. 811(h)(1).
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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 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.'' \21\ 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.\22\ 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,\23\ it is noteworthy that, in section 811(h)(1),
Congress authorized the issuance of temporary scheduling actions by
order rather than by rule.
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\21\ 5 U.S.C. 551(6) (emphasis added).
\22\ 21 U.S.C. 811(a) and 877.
\23\ See 21 U.S.C. 811(a).
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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 Acting Assistant Secretary
in response to the notices that DEA transmitted to the Acting 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. E.O. 12866, sec. 3(f),
provides the definition of a ``significant regulatory action,''
requiring review by the Office of Management and Budget. Because this
is not a rulemaking action, 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.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, DEA amends 21 CFR part 1308 as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. In Sec. 1308.11:
0
a. Remove and reserve paragraph (h)(65); and
0
b. Add paragraph (h)(88).
The addition reads as follows:
Sec. 1308.11 Schedule I
* * * * *
(h) * * *
------------------------------------------------------------------------
------------------------------------------------------------------------
* * * * * * *
(88) O-Desmethyltramadol (other names: O-DSMT; 9667
desmetramadol; 3-[(1R,2R)-2-[(dimethylamino)methyl]-1-
hydroxycyclohexyl]phenol)..............................
------------------------------------------------------------------------
* * * * *
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 6, 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
[[Page 52018]]
electronic format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-16413 Filed 8-11-26; 8:45 am]
BILLING CODE 4410-09-P