TGA approval for OTC sale of melatonin to adults 55+ from 01 June 2021

Question

The Therapeutics Good Administration (TGA) several months ago approved the down-scheduling from Schedule 4 to Schedule 3 of melatonin (up to 2mg) for OTC sale to adults age 55+ from 01 June 2021.

https://www.tga.gov.au/scheduling-decision-final/notice-final-decision-amend-current-poisons-standard-relation-melatonin

noshrinkingviol · Answer

Currently, therapeutic melatonin is available only by prescription in Australia.&nbsp; The melatonin that is on-shelf at chemists, such as from Bioglan, are homeopathic and do not contain therapeutic levels of melatonin.&nbsp; A glass of water may be as effective!

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TGA approval for OTC sale of melatonin to adults 55+ from 01 June 2021

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