The following information on botanical ingredients should be included in either a bulk botanical raw material specification sheet (for business-to-business transactions) or finished product labeling (when selling directly to consumers).
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.
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.
Learn about CHPA's current slate of federal legislative priorities including OTC regulatory reform, dietary supplement regulation modernization, supply chain and product integrity, and more.
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.
Advertising and marketing of dietary supplements are regulated by the FDA, the FTC, and other governmental organizations. Products must be deemed safe prior to marketing and advertisement claims must be substantiated.
