This document serves as a voluntary guideline to assist manufacturers of dietary supplements with compliance with the dietary supplement current good manufacturing practice (cGMP) requirements of the US FDA 21 CFR §111.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
CHPA opposes state and local government attempts to restrict the use of FDA-approved color additives as doing so is vital for maintaining a cohesive regulatory framework.
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).
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.
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 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.
CHPA is the home for responsible members of the consumer healthcare community. We represent leading manufacturers, and the companies that service them, in the area of OTC medicines, dietary supplements, and consumer medical devices.
