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Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules speech activity. Clinical observations demonstrate that mesocarb, while less potent than both methamphetamine and amphetamine, has similar CNS effects as other stimulants, providing evidence that mesocarb has a similar abuse liability.
3. The State of Current Scientific Knowledge Regarding the Drug or Other Substance: Mesocarb is a white crystalline powder, nearly insoluble in water and barely soluble in alcohol. Of the 19 reported metabolites of mesocarb, the main metabolite is phydroxymesocarb conjugated with sulfate, which is detected in human urine and plasma. Amphetamine in trace amounts has also been detected as a metabolite of mesocarb in human urine and blood plasma, and in rat urine. In healthy human volunteers, the estimated detection time for mesocarb after administration was approximately 1011 days, due to the long half-lives of the metabolites.
4. Its History and Current Pattern of Abuse: Abused by athletes worldwide both in training and in competition, mesocarb is on the list of prohibited substances of the World Anti-Doping Agency WADA and banned by the International Olympics Committee. In addition, mesocarb is internationally controlled as a Schedule IV substance under the 1971 Convention. Diversion of legitimately produced mesocarb in Bulgaria was mentioned as a possible problem in the International Narcotics Control Strategy Report INCSR of 1993. In 2000, INCSR reported the primary stimulant of abuse, amphetamine, was being replaced by fenethylline schedule I of the CSA, pemoline schedule IV of the CSA, mesocarb, and ephedrine in that order in western Africa. Queries of DEAs System to Retrieve Information from Drug Evidence STRIDE/STARLiMS 4
and the National Forensic Laboratory Information System NFLIS 5 on May 26, 2021, did not report any occurrence of mesocarb, suggesting that mesocarb is not trafficked in the United States.
5. The Scope, Duration, and Significance of Abuse: As noted above,
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4 STRIDE

is a database of drug exhibits sent to DEA laboratories for analysis. Exhibits from the database are from DEA, other federal agencies, and law enforcement agencies. On October 1, 2014, STARLiMS replaced STRIDE as DEA laboratory drug evidence data system of record.
5 NFLIS is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories across the country.
The NFLIS participation rate, defined as the percentage of the national drug caseload represented by laboratories that have joined NFLIS, is over 97%. NFLIS includes drug chemistry results from completed analyses only.

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mesocarb is prohibited by WADA and banned by the International Olympic Committee. It has been used by athletes worldwide both in training and in competition due to reported effects on learning, memory, work capacity, and antihypoxia. Case reports involving mesocarb abuse have included: 1 A
Lithuanian athlete in the Barcelona 1992 Olympic games; 2 a U.S. citizen in the Tokyo 1991 International Amateur Federation World Championships; 3 a Bulgarian athlete in the Helsinki 1994 European Championships; 4 a report by observers for WADA covering the Mediterranean Games of Tunis Tunisia in 2001; and 5 another WADA report in 2005 following a positive laboratory result that tested positive for mesocarb.
6. What, if any, Risk There is to the Public Health: The presence of mesocarb in the United States is limited because of its lack of accepted medical use. According to HHS, mesocarb is not an approved drug, and there have been no reports of adverse effects related to mesocarb in the United States. Due to the pharmacological similarity of mesocarb to amphetamine and methamphetamine, even though the availability of mesocarb is limited, mesocarb likely presents similar risks to the public health as amphetamine and methamphetamine.
7. Its Psychic or Physiological Dependence Liability: For amphetamine or amphetamine-like substances, related withdrawal symptoms can be moderate or limited and are characterized by craving, irritability, nervousness, psychomotor agitation, paranoia, and sleep disturbances. Although there are no direct assessments of the physiologic and psychic dependence of mesocarb, it does induce locomotor and selfadministration behaviors that are similar to those behaviors induced by amphetamine and methamphetamine.
Mesocarb has been shown to substitute fully at high doses to amphetamine and methamphetamine in a drug discriminative paradigm. Therefore, mesocarb likely elicits a similar physiologic and psychic dependence profile as amphetamine and methamphetamine.
8. Whether the Substance is an Immediate Precursor of a Substance Already Controlled under the CSA: Both HHS and DEA find that mesocarb is not an immediate precursor of any substance already controlled under the CSA.
Conclusion: Based on consideration of the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEAs consideration of its own eight-factor analysis, DEA

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finds that these facts and all relevant data constitute substantial evidence of potential for abuse of mesocarb. As such, DEA hereby proposes to schedule mesocarb as a controlled substance under 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
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 available data, the Administrator of DEA, pursuant to 21 U.S.C. 812b1, finds that:
1 Mesocarb has a high potential for abuse. Mesocarb, similar to amphetamine and many other CNS
stimulants, is a DA uptake inhibitor. In clinical observations, mesocarb produced marked pyschostimulation accompanied with increased mental, physical, locomotor, and speech activity similar to amphetamine, albeit with less potency. Pre-clinical research has also directly compared mesocarb to other CNS stimulants, including amphetamine and methamphetamine that are scheduled and controlled under the CSA due to their well-known high abuse liability. The effects of mesocarb on DA are qualitatively similar to these schedule II stimulants. Intravenous drug self-administration studies in animals have shown that mesocarb has reinforcing effects. Mesocarb shares similar discriminative stimulus effects with amphetamine and methamphetamine, though at larger doses. Amphetamine and methamphetamine have medical use and have high potential for abuse.
2 There are no approved New Drug Applications for mesocarb nor is there a known therapeutic application for mesocarb in the United States.
Therefore, mesocarb has no currently accepted medical use in treatment in the United States.6
6 Although there is no evidence suggesting that mesocarb has currently accepted medical uses in treatment in the United States, it bears noting that a drug cannot be found to have such medical use unless DEA concludes that it satisfies a five-part test. Specifically, with respect to a drug that has not been approved by FDA, to have a currently accepted medical use in treatment in the United States, all of the following must be demonstrated:
i. The drugs chemistry must be known and reproducible; ii. there must be adequate safety studies; iii. there must be adequate and wellcontrolled studies proving efficacy; iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available. 57 FR

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