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Regulatory News | 11 August 2017 | By Zachary Brennan
The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs.
Section 201 of the Controlled Substances Act (CSA) provides that when WHO notifies the US under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services.
The HHS Secretary must then publish the notice in the Federal Register and provide opportunity for comments in preparation of the scientific and medical evaluations.
According to WHO, replies must reach the Secretariat by 30 September 2017, though HHS says in Friday’s notice that it "will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in early 2018. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments."
The notice provides lots of information on the 17 substances under consideration including a list and descriptions:
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments
Tags: drug substances, fentanyl, opioids, cannabis