Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality, and they cannot be legally marketed in the US.
According to the FDA, people may be at greater risk when using these products than using FDA-approved prescription drugs or over-the-counter (OTC) drugs.
Many healthcare providers have unknowingly prescribed unapproved products as the drugs’ labels do not disclose that they lack FDA approval, the FDA noted.
FDA Center for Drug Evaluation and Research Office of Compliance director Deborah Autor said removing these unapproved products from the market will reduce potential risks to consumers.
"There are many FDA-approved prescription products available to treat cough, cold, and allergy symptoms, so, we expect little or no negative impact on consumers from the removal of these unapproved products, "Autor said.
Companies that have previously listed unapproved prescription cough, cold, and allergy drug products are required to stop manufacturing them within 90 days and stop shipping the products within 180 days.
Companies that have not previously listed products are required to stop manufacturing and shipping their products immediately.
This action is a part of FDA’s Unapproved Drugs Initiative which began in June 2006 and it seeks to bring all unapproved new drugs into the approval process.