The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), commonly referred to as ‘The Poisons Standard’, is a legislative instrument which records decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the Australian States and Territories. It includes information on the appropriate supply, labelling and packaging provisions for Scheduled substances. The Standard is updated regularly following consideration of proposed new and changed entries.
A new version, ‘SUSMP No. 35 (Poisons Standard February 2022)’, has been published. The changes are described in the Explanatory Statement which accompanies the new Standard.
Changes include the inclusion of eight new substances as Prescription-only (Schedule 4): molnupiravir, nirmatrelvir, infigratinib, ponesimod, selinexor, selumetinib, sotorasib and tepotinib. Other new additions are: gliptins, isotianil, chromium trichloride hexahydrate, metobromuron, kinetin, rescalure, fluoxapiprolin and disodium manganese EDTA. A proposal to down-schedule amygdalin and hydrocyanic acid naturally present in apricot kernels (typically used in Traditional Chinese Medicine) was not accepted due to safety issues. These remain in Schedule 10 (prohibited from sale, supply and use).
The new version and accompanying Explanatory Statement are available on the webpage.
Contact RegASK to know more about regulation changes in Australia.
Contact RegASK for more details Read more