The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.
Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.
Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.