Drugs@FDA does not include:
• over-the-counter (OTC) products marketed without an application by following a regulation called an OTC drug monograph.
• dietary supplements, which do not require FDA approval to be sold in the United States
• biological products regulated by the Center for Biologics Evaluation and Research
• animal drugs, which are regulated by the Center for Veterinary Medicine
• drugs not approved by FDA
• drugs sold outside the United States that are not approved for marketing in the U.S.
• drugs under review at FDA for which no action (approved or not approved) has occurred yet.
