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18 Dec. 2020

Low dose cannabidiol down-scheduled from Schedule 4 to Schedule 3

Please see partial media release from the Therapeutic Goods Administration (TGA) released on December 15. 

Today the Therapeutic Goods Administration (TGA) announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations from Schedule 4 (Prescription Medicine) to Schedule 3 (Pharmacist Only Medicine).

The decision will allow TGA approved low-dose CBD containing products, up to a maximum of 150 mg/day, for use in adults, to be supplied over-the-counter by a pharmacist, without a prescription. The decision limits over-the-counter supply to only those products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.

There are currently no TGA approved products on the Australian Register of Therapeutic Goods (ARTG) that meet the Schedule 3 criteria.

The TGA can be contacted at info@tga.gov.au(link sends e-mail) or, for supplier and sponsor enquiries, at OTC.medicines@health.gov.au(link sends e-mail).

Please read the official media release here.