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S4, S8 entries for cannabis THE TGA has released details of...

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    S4, S8 entries for cannabis
    THE TGA has released details of
    revised Poisons Standard entries
    for medicinal cannabis, with a
    proposed implementation date of
    01 Oct this year.
    The interim ruling is in line
    with recommendations from the
    Advisory Committee on Medicines
    Scheduling, and amends the
    Schedule 4 entry for cannabidiol,
    and the Schedule 8 and Appendix K
    entries for tetrayhydrocannabidiols
    and cannabis to make them clearer.
    The proposed Schedule 4 entry
    covers cannabidiol in preparations
    for therapeutic use where:
    a. cannabidiol comprises 98%
    or more of the total cannabinoid
    content of the preparation; and
    b. any cannabinoids, other than
    cannabidiol, must be only those

    naturally found in cannabis and
    total 2% or less of the cannabinoid
    content of the preparation.
    Cannabis, including seeds,
    extracts, resins and the plant,
    is also included in Schedule 8
    when cultivated or produced in
    accordance with the Narcotic Drugs
    Act 1967.
    There is also a proposed S8 entry
    for tetrahyrdrocannabidiols when
    extracted from cannabis for human
    therapeutic use.
    The update confirms that the
    “consideration is about clarification
    only and does not seek to change
    the original scheduling decisions”.
    In particular, “clarification of these
    entries is necessary to prevent
    their inadvertent or deliberate
    misinterpretation resulting in
    harm through Schedule 8 products
    being treated as Schedule 4
    medicines, including not obtaining
    State authority to prescribe
    and increased potential for
    diversion/misuse because of less
    restrictive storage and recording
    requirements,” the update notes.
    See tga.gov.au.
 
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