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Some codeine behind the counter Down Under

This article was originally published in The Tan Sheet

Executive Summary

Australia's Therapeutic Goods Administration moves codeine-containing nonprescription painkillers from OTC sales to pharmacy only, but leaves cough and cold preparations with the ingredient on store shelves. TGA's National Drugs and Poisons Schedule Committee in June voted to switch codeine products labeled for 100-mg daily dose limit, with no more than 12 mg in individual doses, starting in May 2010 from schedule 2 - nonprescription sales without pharmacist intervention - to schedule 3, which requires distribution by pharmacists. The committee also set a maximum package size of five days' supply for codeine painkillers and for cough/cold preparations labeled for 60-mg maximum daily dose, with no more than 10 mg in each dose. The change follows concerns about codeine abuse, and the committee noted requiring customers to ask pharmacists for the products would help curb inappropriate use. In the U.S., FDA classifies all codeine products as Rx only, while in other countries, including Australia, some drugs containing the ingredient are available OTC or from pharmacists without prescription

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