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.
The Health in Hand Foundation is dedicated to helping consumers lead happier, healthier lives by providing information and guidance on how to safely use, store, and dispose of OTC medicines, dietary supplements, and OTC medical devices.
Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.
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.
CHPA supports the regulatory authorities governing dietary supplement manufacturing, labeling, and marketing and works to ensure the availability of safe dietary supplements.
Imposing extended producer responsibility (EPR) laws on medical device makers would be an excessive regulation given that most major companies in the industry have already implemented voluntary programs for free consumer battery recycling.
Rather than create a patchwork of statutes across jurisdictions, lawmakers should allow the comprehensive standards established by national microplastics and microbead legislation to facilitate steady industry progress on materials and waste reduction guided by science.
