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Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules U.S.C. 811a1, to add 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144
permanently to schedule I of the CSA.
DEA has reviewed the scientific and medical evaluation and scheduling recommendation received from HHS, and all other relevant data, and conducted its own eight-factor analysis of the abuse potential of 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, pursuant to 21 U.S.C. 811c. Included below is a brief summary of each factor as analyzed by HHS and DEA, and as considered by DEA in its proposed scheduling action. Please note that both DEA Eight-Factor and HHS Eight-Factor analyses and the Acting Assistant Secretarys February 26, 2021, letter are available in their entirety under the tab Supporting Documents of the public docket of this action at http
www.regulations.gov, under Docket Number DEA491.
1. The Drugs Actual or Relative Potential for Abuse: The term abuse is not defined in the CSA. However, the legislative history of the CSA suggests that DEA consider the following criteria in determining whether a particular drug or substance has a potential for abuse: 2

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a There is evidence that individuals are taking the drug or drugs containing such a substance in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; or b There is significant diversion of the drug or drugs containing such a substance from legitimate drug channels; or c Individuals are taking the drug or drugs containing such a substance on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs in the course of his professional practice; or d The drug or drugs containing such a substance are new drugs so related in their action to a drug or drugs already listed as having a potential for abuse to make it likely that the drug will have the same potentiality for abuse as such drugs, thus making it reasonable to assume that there may be significant diversions from legitimate channels, significant use contrary to or without medical advice, or that it has a substantial capability of creating hazards to the health of the user or to the safety of the community.

In its recommendation, HHS noted that the abuse of 5F-EDMB-PINACA, 5FMDMB-PICA, FUB-AKB48, 5F-CUMYLPINACA and FUB-144 is creating a hazard to the health and safety of both the individual users and others within 2 Comprehensive Drug Abuse Prevention and Control Act of 1970, H.R. Rep. No. 911444, 91st Cong., Sess. 1 1970; reprinted in 1970
U.S.C.C.A.N. 4566, 4603.

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the community. Adverse effects have been observed following the ingestion of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 see factor 6. SCs, including 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144, are easily accessible and difficult to detect in standard urine drug screens. These factors are contributing to their popularity and high rates of abuse, while resulting in serious harm to users. In addition, poison centers continue to report the abuse and harm of SCs in general and their associated products. SCs continue to remain a threat to both the shortand long-term public health and safety.
HHS stated in their letter to DEA
dated September 6, 2018, and reiterated in their recommendation dated February 26, 2021, that there are no Food and Drug Administration FDA-approved drug products containing 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA or FUB-144 in the United States and there appear to be no legitimate sources for these substances as marketed drugs. In their recommendation dated February 26, 2021, HHS stated that FDA is not aware of any diversion, from schedule I
research or manufacturing activities, related to these five SCs for the purpose of legitimate drug research.
HHS stated that because 5F-EDMBPINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 are not approved for medical use and are not formulated or available for clinical use, the human use of these substances is assumed to be on an individuals own initiative, rather than on the basis of medical advice from a practitioner licensed by law to administer drugs.
Further, published scientific and medical literature and law enforcement reports indicate that individuals are taking these SCs on their own initiative, rather than on the basis of medical advice of a licensed practitioner.
HHS noted that 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5FCUMYL-PINACA and FUB-144, similar to schedule I SCs e.g., JWH-018, bind to and activate the cannabinoid type 1
CB1 receptors see factor 2. In addition, drug discrimination studies conducted in rodents demonstrate that these five SCs, similar to other schedule I SCs e.g., JWH-018; AM2201; ADBPINACA, AB-FUBINACA, etc., fully substitute for delta-9tetrahydrocannabinol THC in animals trained to discriminate THC from vehicle control see factor 2.
2. Scientific Evidence of the Drugs Pharmacological Effects, if Known: In their recommendation, HHS described
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in vitro receptor binding and functional assays that were conducted using 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144. These results indicate that 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144, similar to other schedule I SCs, bind to CB1 receptors and act as agonists at CB1 receptors. HHS also noted that drug discrimination studies were conducted in animals to evaluate whether the five SCs have cannabinoid characteristics similar to other substances in schedule I of the CSA.
Each of the five SCs were shown to fully substitute for the discriminative stimulus effects produced by delta-9THC. No human studies involving 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA or FUB144 have been reported.
3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: HHS stated that it is important to highlight the fact that the five SCs are structurally unrelated to THC, the principle psychoactive chemical in marijuana. Instead, they are potent cannabinoids that are reported to be smoked for recreational purposes. 5FEDMB-PINACA, 5F-MDMB-PICA, FUBAKB48, 5F-CUMYL-PINACA and FUB144 are all CB1 receptor agonists that are pharmacologically similar to THC.
As stated by HHS, when FDA
approves a drug under the Federal Food, Drug, and Cosmetic Act for human or animal medical use, such drug is considered to have a currently accepted medical use in the United States. In the absence of such approval by FDA, a drug may be considered to have a currently accepted medical use in the United States if DEA concludes that the drug satisfies all of the following five elements: 3
a. The drugs chemistry is known and reproducible;
b. There are adequate safety studies;
c. There are adequate and well-controlled studies proving efficacy;
d. The drug is accepted by qualified experts; and e. The scientific evidence is widely available.

According to the HHS
recommendation, none of the five SCs has been approved by FDA as a human or animal drug product in the United States or, to FDAs knowledge, been approved for medical use in any other country. Moreover, there are no wellcontrolled clinical studies showing safety or efficacy for any of these 3 57 FR 10492 1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 D.C. Cir. 1994.

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