Explore our list of resources to learn more about the dietary supplement category and how it is regulated by the U.S. Food and Drug Administration and Federal Trade Commission.
CHPA supports a review of existing rules and coordination efforts to identify opportunities that could mitigate shortage risks during times of peak need.
Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.
Since existing federal laws already mandate comprehensive disclosure of all clinically relevant ingredients plus extensive post-market oversight, further state and local requirements layered on may afford minimal practical advantages.
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.
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.
Up and Away reminds families of the importance of safe medicine storage to prevent young children from accidentally getting into medicine. It is led by the CDC and Health in Hand, in partnership with the PROTECT Initiative.
