Regulatory Focus™ > News Articles > FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

Posted 10 January 2017 | By Zachary Brennan 

FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances.

The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2017.
WHO proposes to place in Schedule I of the Single Convention on Narcotic Drugs (1961), as amended by the 1972 Protocol:  

  • U-47700, a synthetic opioid drug developed in the 1970s
  • Butyrfentanyl, a synthetic opioid and analog of fentanyl

And to be placed in Schedule II of the Convention on Psychotropic Substances (1971), WHO recommends:

  • 4-MEC (4-methylethcathinone), a synthetic cathinone structurally and pharmacologically similar to amphetamine
  • ethylone, has been sold as the street drug “Molly” and encountered as a replacement for methylone
  • pentedrone, similar to an amphetamine
  • ethylphenidate
  • MPA (methiopropamine), a structural analogue of the Schedule II controlled substance methamphetamine
  • MDMB-CHMICA, an indole-based synthetic cannabinoid
  • 5F-APINACA, a synthetic cannabinoid
  • XLR-11, an indole-based synthetic cannabinoid

In addition, the expert committee recommended carrying out a critical review at its next meeting for: 3-MMC (3-Methylmethcathinone) and to continue to keep the following substance under surveillance: JWH-073.

The committee also called for another meeting dedicated to cannabis and its component substances to be held within the next 18 months from the UN meeting.

According to FDA, 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 Psychotropic Convention include: (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.

International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; 4- Methylethcathinone and Nine Other Substances; Request for Comments


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