This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
CHPA supports a review of existing rules and coordination efforts to identify opportunities that could mitigate shortage risks during times of peak need.
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 purpose of these guidelines is to catalog and strengthen standards of care that have evolved in the practice of providing unsolicited free samples of OTC medicines to consumers to promote their products.
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.
