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Repackager of foreign drugs agrees to comply with FDA's rules

ROCKVILLE, MD., April 13, 2004 -- The FDA announced settlement of a court case against an Illinois firm involved last year in FDA's seizure of thousands of imported unapproved drugs, including those that were labeled in foreign languages and/or labeled as repacked.

The firm, Phil and Kathy's, Inc., a corporation doing business as Local Repack, Alliance Wholesale Distributor, and Local Pharmacy, signed on April 8 a consent decree in the United States District Court for the Northern District of Illinois agreeing to operate in full compliance with FDA's regulations.

"FDA protects the health of Americans by enforcing laws designed to ensure the safety, effectiveness and quality of all medications on the U.S. market," said Dr. Lester M. Crawford, Acting FDA Commissioner. "Products that are illegally distributed outside this protective system pose a serious threat to patients."

FDA's inspections in 2003 revealed that Phil and Kathy's was importing and repacking drug products that were labeled in Spanish and Portuguese and not in accordance with FDA's approvals. In addition, the firm has repeatedly failed to comply with FDA's current good manufacturing practice (cGMP) requirements, which serve to ensure that every marketed drug is safe, effective and properly manufactured.

Under the consent decree, Phil and Kathy's is prohibited from manufacturing, labeling and distributing any article of drug until it meets certain conditions, the most important of which is the FDA's determination that the firm's repackaging operations comply with cGMP. In addition, Phil and Kathy's agrees not to repackage any foreign-labeled drugs or drugs that are in any manner inconsistent with FDA's standards for approval. In case the firm purchases, distributes, or imports any such products, the consent decree gives the government additional authority to seek monetary damages.

The consent decree does not deal with the charges against Genendo Pharmaceutical, N.V., the importer of several drugs to Phil and Kathy's, which are still pending.

Source: FDA

Posted: April 2004