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Consumer Update |
PharmaFab Inc. has entered a legal agreement with FDA under which the firm will stop the illegal manufacture and distribution of prescription and over-the-counter drug products.
The agreement calls for PharmaFab, a contract maker and distributor of more than 100 different drug products, to halt unlawful practices that include selling items not made according to the required current good manufacturing practice (CGMP). Many of these products also lack required FDA approval. PharmaFab's products include cough and cold medicines, and treatments for ulcers and postpartum hemorrhage.
The company must also destroy certain illegal drugs, and is barred from distributing all drugs until it obtains required FDA approval and fully complies with CGMP.
FDA recommends that consumers who have PharmaFab products consult with their physician.
The unapproved drugs manufactured by PharmaFab include, but are not limited to:
These drugs have not undergone FDA approval. This means:
The agreement is officially a Consent Decree of Permanent Injunction that FDA entered against PharmaFab Inc.; its subsidiary, PFab LP; and two company officials. It was filed in the United States District Court for the Northern District of Texas.
"Drug approval and CGMP compliance are part of the foundation of drug safety," says Steven K. Galson, M.D., M.P.H, Director of FDA's Center for Drug Evaluation and Research (CDER). "When companies and individuals choose not to comply with the law, FDA must deal with these problems decisively."
For more information, visit:
FDA's ongoing efforts on marketing unapproved drugs
www.fda.gov/cder/drug/unapproved_drugs
CDER's Web page on Compliance with Current Good Manufacturing Practices
www.fda.gov/cder/dmpq/
Date Posted: May 21, 2007
