Which of the following is NOT a reason to file an OMOR?

Filing an Over-the-Counter Market Notification (OMOR) is typically required for significant changes that affect the regulatory status or safety profile of a product. The correct answer identifies that switching a product from prescription to over-the-counter is not considered a legitimate reason for filing an OMOR.

This is because the transition from prescription to over-the-counter status involves a more extensive regulatory process, generally requiring a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) submission. It entails a comprehensive review of evidence demonstrating that the product can be used safely and effectively by consumers without a prescription. The other options align more closely with changes that might qualify for an OMOR, as they typically involve updates or modifications to the existing product that can be managed within the framework of the existing approval rather than requiring a complete reclassification of the product's status.