Voglio sapere a riguardo di…

10102

Federal Register / Vol. 86, No. 31 / Thursday, February 18, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES

benzodiazepines. There have been reports of abuse, impaired driving and fatal and nonfatal intoxications. There is sufficient evidence of its abuse so as to constitute a significant risk to public health, and it has no known therapeutic use.
The Committee recommended that diclazepam Chemical name: 7-chloro-5-2chlorophenyl-1-methyl-1,3-dihydro-2Hbenzoe1,4diazepin2-one be added to Schedule IV of the 1971 Convention on Psychotropic Substances.
Flubromazolam Substance Identification Flubromazolam Chemical name: 8-bromo6-2-fluorophenyl-1-methyl-4Hbenzof1,2,4triazolo4,3-a1,4diazepine is a 1-4 triazolobenzodiazepine. Flubromazolam is a white powder, often sold as a liquid or as tablets.
WHO Review History Flubromazolam has never been formally reviewed by WHO and is not currently under international control. Information was brought to WHOs attention that this substance is clandestinely manufactured, poses a risk to public health and has no recognized therapeutic use.
Similarity to Known Substances and Effects on Central Nervous System Flubromazolam is a highly potent benzodiazepine with long lasting depressant effects on the central nervous system.
Flubromazolam enhances the effects of the inhibitory neurotransmitter gammaaminobutyric acid GABA through binding at the benzodiazepine site of the GABA-A
receptor. This mechanism of action, as well as its effects, are similar to those of the benzodiazepines triazolam and alprazolam which are controlled under Schedule IV of the 1971 Convention on Psychotropic Substances.
A single pharmacokinetic study showed that a 0.5 mg flubromazolam dose induced strong sedative effects that lasted more than 10 hours, and caused partial amnesia for more than 24 hours. The effects of flubromazolam have been effectively reversed by the benzodiazepine antagonist flumazenil.
Reports from online user forums describe benzodiazepine-like effects including anxiolytic, euphoric and sedative effects.
Dependence Potential No controlled animal or human studies describe the dependence potential of flubromazolam, although multiple reports from online sources describe severe withdrawal symptoms, such as muscle aches, sleeping disorders, severe anxiety and panic attacks, dissociative symptoms, perceptual distortions, cramping, chills, vomiting and risk of seizures. There are also descriptions of loss of control over use, and rapid onset of tolerance. The latter suggests that taking increased doses and developing physical dependence is likely.
Actual Abuse and/or Evidence of Likelihood of Abuse No controlled animal or human studies have assessed the abuse potential of
VerDate Sep<11>2014

17:47 Feb 17, 2021

Jkt 253001

flubromazolam. Impaired driving with flubromazolam as the sole intoxicant is reported. Non-fatal intoxications requiring hospital admission, and fatal intoxications due to flubromazolam use are documented.
In these cases, central nervous system depression and severe sedation were clinical features of presentation. Flubromazolam has the potential to increase unintentional opioid overdoses. Its long half-life may increase the risk of accumulation and interactions when combined with other drugs.
Nonmedical use and seizures of flubromazolam have been documented in multiple countries across different regions. It is increasingly sold as falsified pharmaceutical benzodiazepines.
Therapeutic Usefulness Flubromazolam is not known to have any therapeutic uses, is not listed on the WHO
Model List of Essential Medicines and has never been marketed as a medicinal product.
Recommendation Flubromazolam Chemical name: 8-bromo6-2-fluorophenyl-1-methyl-4Hbenzof1,2,4triazolo4,3-a1,4diazepine is a 1-4 triazolobenzodiazepine that has actions and effects very similar to those of benzodiazepines listed under Schedule IV in the Convention on Psychotropic Substances of 1971. It can produce a state of dependence and central nervous system depression, like other benzodiazepines. There have been increasing reports of abuse, impaired driving and fatal and non-fatal intoxications. There is sufficient evidence of its abuse to constitute a significant risk to public health, and it has no known therapeutic use.
The Committee recommended that flubromazolam Chemical name: 8-bromo-62-fluorophenyl-1-methyl-4Hbenzof1,2,4triazolo4,3-a1,4diazepine be added to Schedule IV of the 1971
Convention on Psychotropic Substances.

III. Discussion Although WHO has made specific scheduling recommendations for each of the drug substances, the CND is not obliged to follow the WHO
recommendations. Options available to the CND for substances considered for control under the 1971 Convention include the following: 1 Accept the WHO recommendations; 2 accept the recommendations to control but control the drug substance in a schedule other than that recommended; or 3 reject the recommendations entirely.
Isotonitazene chemical name: N,Ndiethyl-2-2-4-isopropoxybenzyl-5nitro-1H-benzimidazol-1-ylethan-1amine is a potent synthetic opioid that is abused similar to other synthetic opioids. Its use has resulted in adverse health effects, including positively identified in 49 death investigation cases in the United States between August 2019 and April 2020. Law enforcement data indicate that isotonitazene has appeared in the United States illicit drug market.

PO 00000

Frm 00069

Fmt 4703

Sfmt 4703

According to the National Forensic Laboratory Information System NFLIS
database, there have been 53 encounters of isotonitazene in the United States as of June 2020. There are no commercial or approved medical uses for isotonitazene. On August 20, 2020, the Drug Enforcement Administration issued an order to temporarily control isotonitazene as a Schedule I substance under the CSA. As such, additional permanent controls will be necessary to fulfill U.S. obligations if isotonitazene is placed in Schedule I of the 1961
Convention.
CUMYL-PEGACLONE is a synthetic cannabinoid that has been sold online and used to mimic the biological effects of tetrahydrocannabinol THC, the main psychoactive constituent in marijuana. Research and clinical reports have demonstrated that synthetic cannabinoids are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and psychoactive high.
Synthetic cannabinoids have been marketed under the guise of herbal incense, and promoted by drug traffickers as legal alternatives to marijuana. In vitro studies demonstrate that CUMYL-PEGALCONE binds to and activates the cannabinoid one receptor.
CUMYL-PEGALCONE has not been encountered within the United States according to the NFLIS database as of January 14, 2021. There are no commercial or approved medical uses for CUMYL-PEGALCONE and it is not a controlled substance under the CSA. As such, additional permanent controls will be necessary to fulfill U.S.
obligations if CUMYL-PEGALCONE is controlled under Schedule II of the 1971
Convention.
MDMB-4en-PINACA is a synthetic cannabinoid that has been sold online and used to mimic the biological effects of THC, the main psychoactive constituent in marijuana. Research and clinical reports have demonstrated that synthetic cannabinoids are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and psychoactive high.
Synthetic cannabinoids have been marketed under the guise of herbal incense, and promoted by drug traffickers as legal alternatives to marijuana. According to the NFLIS
database, MDMB-4en-PINACA was first encountered in the United States in January 2019. There have been 3,331
encounters of MDMB-4en-PINACA in the United States as of January 14, 2021. MDMB-4en-PINACA has also been encountered mixed with opioids including heroin and fentanyl, with some incidents resulting in violent
E:FRFM18FEN1.SGM

18FEN1