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Cape Drugs cited for compounding medicines with domperidone.
On Feb. 25, a Special Agent with FDA's Office of Criminal Investigations determined that Cape Drugs, Annapolis, MD, was compounding pharmaceuticals containing domperidone--an unapproved drug that is not recognized to be safe and effective. The firm then was issued a July 11 warning letter.
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 product was misbranded because the labeling failed to bear adequate directions for use.
Additionally, the agency said it is concerned with the public health risks associated with the compounding of domperidone.
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