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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Proposed Rules alternative to fentanyl. Between 2017
and 2020, law enforcement officials in the United States encountered these 10
substances.
5. The Scope, Duration, and Significance of Abuse: 2-Fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, similar to other substances structurally related to fentanyl, are often used as recreational drugs. The recreational use of these 10
substances and other fentanyl-related substances continues to be of significant concern as the United States currently is in the midst of an opioid epidemic.
These substances are distributed to users, often with unpredictable outcomes. Because users of these fentanyl-related substances and their associated drug products are likely to obtain these substances through unregulated sources, the identity, purity, and quantity are uncertain and inconsistent, thus posing significant adverse health risks to abusers.
Evidence that these 10 substances are being abused and trafficked is confirmed by law enforcement encounters. NFLIS contained 235
reports of 4-methyl acetyl fentanyl, bmethyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl from Federal, State, and local forensic laboratories between 2017 and 2020. In 2017 and 2018, CBP reported that 2-fluoro orthofluorofentanyl and b-phenyl fentanyl have been positively identified in seized drugs, respectively. In 2018, orthomethyl methoxyacetyl fentanyl was positively identified in an exhibit submitted to NMS laboratories for analysis by the Department of Homeland Security.
6. What, if Any, Risk There Is to the Public Health: The increase in opioid overdose deaths in the United States has been exacerbated by the availability of potent synthetic opioids such as fentanyl and structurally related substances in the illicit drug market.
These substances have a history of being trafficked as replacements for heroin and other synthetic opioids.
Increasingly, law enforcement has encountered fentanyl and substances structurally related to fentanyl in counterfeit prescription opioids, heroin, and other street drugs such as cocaine, methamphetamine, and synthetic cannabinoids. Fentanyl is a potent synthetic opioid that is primarily prescribed for acute and chronic pain
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and is approximately 100 times more potent than morphine. As such, fentanyl has a high risk of abuse, dependence and overdose that can lead to death.
Because fentanyl-related substances, as defined in the February 6, 2018, temporary order, have similar chemical structure to fentanyl, these substances are expected to have similar biological effects. In in vitro and in vivo studies, 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, bphenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl produced pharmacological effects similar to fentanyl. Thus, these 10 substances pose the same qualitative public health risks as heroin, fentanyl, and other mu-opioid receptor agonists.
According to a CDC report, from 2013
to 2017, opioid-related overdose deaths in the United States increased 90
percent from 25,052 to 47,600. The increase in the number of opioid-related deaths was primarily driven by illicitly manufactured fentanyl.6 According to CDC 2018 provisional data, there were 68,500 drug overdose fatalities; of those, 47,600 69 percent involved an opioid.
The use of some fentanyl-related substances has been associated with adverse health outcomes, including death.
7. Its Psychic or Physiological Dependence Liability: There are no preclinical and clinical studies that have evaluated the dependence potential of 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, bphenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl. These 10
substances are mu-opioid receptor agonists, and discontinuation of the use of mu-opioid receptor agonists such as fentanyl and morphine is known to cause withdrawal indicative of physical dependence. Opioid withdrawal includes nausea and vomiting, depression, agitation, anxiety, craving, sweats, hypertension, diarrhea, and fever.
8. Whether the Substance Is an Immediate Precursor of a Substance Already Controlled Under the CSA: 26 If evidence of prescription or illicit use was not available, fentanyl was categorized as illicitlymanufactured fentanyl IMF because the vast majority of fentanyl overdose deaths involve IMF.
Gladden RM, ODonnell J, Mattson CL, Seth P.
Changes in Opioid-Involved Overdose Deaths by Opioid Type and Presence of Benzodiazepines, Cocaine, and Methamphetamine25 States, July December 2017 to JanuaryJune 2018. MMWR Morb Mortal Wkly Rep. 30; 6834:737744.

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Fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, bphenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para-methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl are not considered immediate precursors of any controlled substance of the CSA as defined by 21 U.S.C. 80223.
Conclusion: After considering the scientific and medical evaluation conducted by HHS, HHSs scheduling recommendation, and DEAs own eightfactor analysis, DEA finds that the facts and all relevant data constitute substantial evidence of the potential for abuse of 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl. As such, DEA
hereby proposes to permanently schedule 2-fluoro ortho-fluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl in schedule I of the CSA.
Proposed Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary for Health of HHS and review of all other available data, the Acting Administrator of DEA, pursuant to 21
U.S.C. 811a and 21 U.S.C. 812b1, finds that:
1 2-Fluoro ortho-fluorofentanyl, 4methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, orthofluorobutyryl fentanyl, ortho-methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl have a high potential for abuse.
According to HHS, 2-fluoro orthofluorofentanyl, 4-methyl acetyl fentanyl, b-methyl fentanyl, b-phenyl fentanyl, ortho-fluorobutyryl fentanyl, ortho-methyl acetylfentanyl, orthomethyl methoxyacetyl fentanyl, paramethylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl, similar to fentanyl, are mu-opioid receptor agonists. These
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