FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia’s TGA Requires Blister Packs, Boxed Warnings for Opioids

Nov. 8, 2019
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Australia’s Therapeutic Goods Administration (TGA) plans to require blister packs and boxed warnings for opioid products.

The new regulations requiring smaller pack sizes for immediate-release prescription opioids will go into effect in Jan. 2020, the agency said, to lower the amount of opioids patients receive when they only require medication for several days.

The TGA will also require sponsors to place boxed warnings on their product information documents, according to the potential for abuse. The indications listed in the documents must emphasize that opioids should only be used after other analgesics have been found to be ineffective, the agency said.

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