Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.
Given pharmacists' drug knowledge and public accessibility, states are exploring expanding their scope of practice permanently after the pandemic emergency measures expire. Empowering pharmacists to dispense products like oral contraceptives, and other consumer healthcare products could improve access and outcomes.
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.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
Providing coverage for clinically-validated, over-the-counter products capable of preventing complications or replacing higher cost prescriptions through flexible spending arrangements aligns with value-based models working to improve access and outcomes across populations.
The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.
