Companies that manufacture and distribute certain unapproved drugs containing the pain reliever oxycodone will have 45 days to stop making those products and 90 days to stop shipping them, the U.S. Food and Drug Administration announced Thursday.
The FDA's notice in the Federal Register said the agency would take enforcement action against all unapproved, single-ingredient, immediate-release products containing oxycodone that are taken orally—including tablets, capsules and oral solutions—and are labeled for human use.
“Oxycodone is a derivative of opium, and, like all opioid products, drugs that contain oxycodone can produce euphoria (a sense of well-being), have the potential to be highly addictive, and are extremely popular drugs of abuse,” the 12-page notice said.
Those drugs that were introduced onto the market before Sept. 19, 2011, were listed in the FDA's Drug Registration and Listing System before July 6, 2012, and were used or sold commercially before July 6, 2012, are subject to the new guidance. The agency indicated that “enforcement action” against these companies could mean seizure, injunction, or other judicial and administrative proceedings.
“Since FDA-approved versions of these oral dosage forms are available by prescription, there should be no negative impact on consumers as a result of this action and no disruptions to the drug supply,” Ilisa Bernstein, acting director of the office of compliance in the FDA's Center for Drug Evaluation and Research
, said in a news release.