FDA Notifies Manufacturers to Stop Production and Distribution of Unapproved Oxycodone Products

July 11, 2012 3:24 pm Topics: Controlled substances and Federal regulations

Food and Drug Administration (FDA) has issued a Federal Register notice (PDF) instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The agency indicates in a news release that the “action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. These products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States.”

FDA states that companies with certain products that are subject to this action are expected to stop manufacturing the products within 45 days and stop shipping the products within 90 days. Products that are subject to these time frames are products that:

• were introduced onto the market before September 19, 2011,
• were listed in the FDA’s Drug Registration and Listing System before July 6, 2012, and
• were being commercially used or sold before July 6, 2012.

Companies that continue to market products that fall within the scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceedings.

Ilisa Bernstein, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research stated, “It’s a high public health priority for FDA to remove these unapproved products from the market to minimize consumer exposure to drugs that may be unsafe, ineffective, and of poor quality.” Bernstein noted further that there should be no disruptions to the drug supply and no negative impact on consumers since “FDA-approved versions of these oral dosage forms are available by prescription.”