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Article: Cape Drugs, Annapolis, MD, July 11 (CDER).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
- Article from:
- Warning Letter Bulletin
- Article date:
- August 1, 2005
CopyrightCOPYRIGHT 2005 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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On Feb. 25, a Special Agent with FDA's Office of Criminal Investigations determined that Cape Drugs was compounding drugs containing domperidone--an unapproved drug, which is not recognized to be safe and effective.
Domperidone has been used by women who are pregnant or nursing to increase milk production, because it may increase the secretion of prolactin, a hormone that is needed for lactation.
According to FDA's Compliance Policy Guide, however, firms cannot compound finished drugs from bulk active ingredients that are not components of FDA-approved drugs without an FDA-sanctioned investigational NDA.
The agency also determined that this ...