Rx depot to stop importing drugs from Canada

FDA Consumer, Nov-Dec, 2004

The FDA has announced the filing of a consent decree of permanent injunction against Rx Depot Inc. and Rx of Canada LLC, based on violations of the Federal Food, Drug, and Cosmetic Act. Both firms and corporate officers Carl Moore and David Peoples admitted liability for causing the importation of unapproved drugs front Canada, and they agreed to stop.

"The defendants' illegal importation of drugs posed a significant public health threat," says Dr. Lester M. Crawford, Acting FDA Commissioner. This applies to unapproved drugs that are imported from foreign countries and U.S.-manufactured drugs that are imported back into the United States by parties other than the manufacturer. Because these drugs are not subject to FDA oversight and are not continuously under the custody of a U.S. manufacturer or authorized distributor, their quality is unpredictable. They could be outdated, contaminated, or counterfeit, or could contain the wrong amount of the active ingredient. The drugs may also have been held under uncertain storage conditions.

The consent decree permanently restrains the defendants from any illegal importation of prescription drugs. The decree gives the FDA inspection authority to ensure compliance and sets a penalty of $4,000 per day for any violation.