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  • 1.  Clinical development of cannabinoids

    This message was posted by a user wishing to remain anonymous
    Posted 06-Sep-2021 20:19
    This message was posted by a user wishing to remain anonymous

    Dear community,

    If anyone has experience with the clinical development of cannabinoids, could you please indicate me if the cannabinoids are completely from laboratory synthesis, are they still considered as controlled substances ?

    Thank you for your help !

    KR


  • 2.  RE: Clinical development of cannabinoids

    Posted 07-Sep-2021 09:44
    Yes they are

    Sent from my phone


    Original Message


  • 3.  RE: Clinical development of cannabinoids

    Posted 07-Sep-2021 11:21
    Edited by Maddi Myers 08-Sep-2021 10:41
    Hello, 

    When I was at RAPS a couple years ago, there was a great presentation on the state of regulation for cannabidiols. At the time, the only approved drug from FDA was Epidiolex. That may still be the only approved product but I haven't really kept up on that. One of the things that was discussed was that, because the dosage had to be controlled during manufacturing, they had to use either synthesized or ultra purified versions of the substance. Taking a less controlled strategy to developing a cannabinoid drug product would have a hard time with the FDA. 

    Cannabis research and drug approval

    Maddi Myers

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    Maddi Myers
    Regulatory and Quality Project Manager
    Carver MN
    United States
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    Original Message


  • 4.  RE: Clinical development of cannabinoids

    Posted 07-Sep-2021 13:28
    Edited by Ed Panek 07-Sep-2021 13:28
    Delta 8 which has most of the properties of the controlled substance is not controlled and may be worthy of looking into.

    What Is Delta 8? (webmd.com)

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 5.  RE: Clinical development of cannabinoids

    Posted 07-Sep-2021 20:36
    Dear KR,

    What jurisdiction are you looking at?

    In the US, cannabinoids derived from hemp were excluded from the definition of cannabis by the Farm Bill of 2018. For a while, the DEA allowed synthetically manufactured equivalents to be exempt as well (they are the same compounds, but more pure!) However, they appeared to change their interpretation in August 2020; honestly, it's rather fuzzy and I don't think they thought this through. Try contacting your local DEA field office. 

    In contrast, some European authorities prefer synthetically manufactured cannabinoids. They will look very carefully at your limits for d8 and d9 THC, but you may be able to be exempt from controlled status. Each country has different criteria and must be contacted individually. 

    Good luck!
    Karen

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    Karen Long RAC
    Vancouver BC
    Canada
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    Original Message


  • 6.  RE: Clinical development of cannabinoids

    Posted 09-Sep-2021 10:05
    Hi,

    Just to add a few more information:

    Synthetic cannabinoids, e.g., Lenabasum (Schedule I), Marinol (Schedule III), are considered controlled substances.  Hemp products with no more than 0.3% THC on a dry weight basis are descheduled (removed from the definition of marijuana in the Controlled Substances Act) under the 2018 Farm Bill in US.

    There was an interesting related article from RAPS regarding "unscheduled" CBD products.
    https://www.raps.org/news-and-articles/news-articles/2021/8/fda-reaffirms-that-cbd-products-cant-be-marketed-a


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    Ji-Eun Kim RAC, RPH, PhD
    Director, Regulatory Affairs
    Scarsdale NY
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    Original Message


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