U.S. FDA Adverse Event Contact Requirement for OTC Drug Labels
U.S. FDA requires labels of OTC drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of serious adverse eventsA serious adverse event is a health related event associated with the use of a drug product that results in or requires medical intervention to prevent death or other serious injury.. Marketing an OTC drug in the U.S. without this contact information is a prohibited act that may result in civil penalties or other FDA enforcement action.
Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA. For more information, simply complete the form below.