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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