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Fri, Aug 1, 2014

Companies warned to pull unapproved drugs from market

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The U.S. Food and Drug Administration has warned companies it is ramping up efforts to stop the manufacturing and distribution of unapproved drugs that contain oxycodone.

The agency issued a federal register notice Thursday instructing companies there will be zero tolerance for violating regulations, as part of the Unapproved Drugs Initiative aimed at removing the illegal products from the American market.

“It’s a high public health priority for the FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality,” said Ilisa Bernstein, acting director of the Office of Compliance with Center for Drug Evaluation and Research.

Oxycodone is a powerful painkiller that is listed under Schedule II of the Controlled Substances Act due to its high abuse and dependency rate when used inappropriately.

Despite the federal restrictions, the number of Americans who have either died or become addicted to oxycodone has sharply risen in the last decade.

The action affects companies that sell unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions, according to an FDA press release.

Companies that are subject to the notice must stop producing the products within 45 days and stop shipping the drugs within 90 days.

Officials said because these products have not been evaluated, companies are not allowed to legally market the drugs in the country.

“Because approved versions of these oral dosage forms are available by prescription,” Bernstein said, “there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply.”

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