In early March, the U.S. Food and Drug Administration reported that it “intends to remove certain unapproved prescription medicines intended to relieve cough, cold, and allergy symptoms from the U.S. market.”
FDA's concern: “Some [meds] may have potentially risky combinations of ingredients, while others—marketed as “timed-release”—may release active ingredients too slowly, too quickly, or inconsistently. FDA has also received reports that some of the products have names that look or sound similar to other products—a problem that could contribute to medication errors.In addition, FDA health experts are concerned that some of the products are inappropriately labeled for use by infants and young children. Many of the unapproved drug products covered [by FDA's announcement] contain the same ingredients as the over-the-counter cough and cold products that were the subject of a 2008 FDA public health advisory.”
In its announcement, the FDA also provided three Web sites to check for “approved drug lists.” They are Drugs@FDA, the Orange Book List of Approved Drug Products, and the National Drug Code Directory of prescription drugs and insulin products.
-Jim Butschli, Editor, Healthcare Packaging
