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Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations
with heroin a schedule I substance and fentanyl a schedule II substance. In reports from the Northeastern Illinois Regional Crime Laboratory, suspected heroin/fentanyl powders were analyzed and found to be brorphine in combination with flualprazolam, a nonscheduled benzodiazepine, and diphenhydramine, an over-the-counter antihistamine.5
Post-mortem toxicology samples collected and submitted to National Medical Services NMS Laboratory 6 in June and July 2020 verified the identification of brorphine. Brorphine was first reported by the Center for Forensic Science Research and Education CFSRENovel Psychoactive Substance NPS
Discovery Program under the novel psychoactive substances discovery program, in collaboration with NMS
Labs in July 2020. In seven postmortem toxicology reports in June and July 2020, brorphine was found in combination with fentanyl, flualprazolam, and heroin. Evidence suggests that individuals are using brorphine as a replacement to heroin or other opioids, either knowingly or unknowingly.
Factor 5. Scope, Duration, and Significance of Abuse Brorphine has been described as a potent synthetic opioid, and evidence suggests it is being abused for its opioidergic effects see Factor 6.
According to a recent publication by CFSRENPS Discovery Program, brorphine has been positively identified in seven death investigation cases spanning between June and July 2020.
These cases occurred in three states Illinois 3, Minnesota 3, and Arizona 1. Most n=6 of the decedents were male. The decedents ages ranged between 40s and 60s with an average age of 52 years. Other substances identified in postmortem blood specimens obtained from these decedents include flualprazolam, a nonscheduled benzodiazepine n=5, fentanyl, a schedule II substance n=7, and heroin, a schedule I substance n=4. The appearance of 5 Email communications with Northeastern Illinois Regional Crime Laboratory, dated 7/1/2020
and 6/11/2020.
6 NMS Labs, in collaboration with the Center for Forensic Science Research and Education at the Fredric Rieders Family Foundation and the Organized Crime Drug Enforcement Task Force at the United States Department of Justice, has received funding from the Centers for Disease Control and Prevention to develop systems for the early identification and notification of novel psychoactive substances in the drug supply within the United States.

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benzodiazepines and other opioids is common with polysubstance abuse.
NFLIS registered 20 reports of brorphine from Ohio 4, Pennsylvania 1, and Wisconsin 15 in 2019 and 2020. NFLIS was queried on August 18, 2020, for brorphine. Due to the rapid appearance of the drug, brorphine is most likely under reported as forensic laboratories secure reference standards for the confirmative identification and reporting of this substance.
The population likely to abuse brorphine appears to be the same as those abusing prescription opioid analgesics, heroin, tramadol, fentanyl, and other synthetic opioid substances.
This is evidenced by the types of other drugs co-identified in samples obtained from brorphine seizures and postmortem toxicology reports. Because abusers of brorphine are likely to obtain it through unregulated sources, the identity, purity, and quantity of brorphine are uncertain and inconsistent, thus posing significant adverse health risks to the end user. The misuse and abuse of opioids have been demonstrated and are wellcharacterized. According to the most recent data from the National Survey on Drug Use and Health NSDUH,7 as of 2019, an estimated 10.1 million people aged 12 years or older misused opioids in the past year, including 9.7 million prescription pain reliever misusers and 745,000 heroin users. In 2019, an estimated 1.6 million people had an opioid use disorder, which included 1.4
million people with a prescription pain reliever use disorder and 438,000
people with heroin use disorder. In 2018, an estimated 10.3 million people aged 12 years or older misused opioids in the past year, including 9.9 million prescription pain reliever misusers and 808,000 heroin users. In 2018, an estimated 2 million people had an opioid use disorder, which included 1.7
million people with a prescription pain reliever use disorder and 500,000
people with heroin use disorder. This 7 NSDUH, formerly known as the National Household Survey on Drug Abuse NHSDA, is conducted annually by the Department of Health and Human Services Substance Abuse and Mental Health Services Administration SAMHSA. It is the primary source of estimates of the prevalence and incidence of nonmedical use of pharmaceutical drugs, illicit drugs, alcohol, and tobacco use in the United States. The survey is based on a nationally representative sample of the civilian, noninstitutionalized population 12 years of age and older. The survey excludes homeless people who do not use shelters, active military personnel, and residents of institutional group quarters such as jails and hospitals. The NSDUH provides yearly national and state level estimates of drug abuse, and includes prevalence estimates by lifetime i.e., ever used, past year, and past month abuse or dependence.

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population abusing opioids is likely to be at risk of abusing brorphine.
Individuals who initiate use i.e., use a drug for the first time of brorphine are likely to be at risk of developing substance use disorder, overdose, and death similar to that of other opioid analgesics e.g., fentanyl, morphine, etc.. Law enforcement reports demonstrate that brorphine is being illicitly distributed and abused.
Factor 6. What, if Any, Risk There Is to the Public Health The increase in opioid overdose deaths in the United States has been exacerbated recently by the availability of potent synthetic opioids on the illicit drug market. Data obtained from preclinical studies demonstrate that brorphine exhibits a pharmacological profile similar to that of other muopioid receptor agonists. Data from in vitro studies showed that brorphine binds to and activates the mu-opioid receptors. In the 35SGTPgS cell-based receptor assay, brorphine, similar to fentanyl, acted as a mu-opioid receptor agonist. Brorphines activation of the mu-opioid receptor was also shown to involve recruitment of beta-arrestin-2, a regulatory protein whose interaction with the mu-opioid receptor has been implicated in the adverse effects of muopioid receptor activation. Brorphine binds to and activates the mu-opioid receptor and has efficacy on scale with fentanyl in in vitro studies. It is well established that substances that act as mu-opioid receptor agonists have a high potential for addiction and can induce dose-dependent respiratory depression.
As with any mu-opioid receptor agonist, the potential health and safety risks for users of brorphine are high.
The public health risks associated to the abuse of heroin and other m-opioid receptor agonists are well established and have resulted in large numbers of drug treatment admissions, emergency department visits, and fatal overdoses.
According to the Centers for Disease Control and Prevention CDC, opioids, mainly synthetic opioids other than methadone, are predominantly responsible for drug overdose deaths in recent years. A CDC report shows that, from 2013 to 2018, opioid-related overdose deaths in the United States increased from 25,052 to 46,802. Of the drug overdose deaths for 2018, opioids were involved in about 69.5 percent of all drug-involved overdose deaths.
In the United States, the abuse of opioid analgesics has resulted in large numbers of treatment admissions, emergency department visits, and fatal overdoses. The introduction of potent synthetic opioids such as brorphine into
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