CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.
CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.
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.
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.
Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.
This document serves as a guideline for the preparation by suppliers and appropriate use by their customers of a Certificate of Analysis (COA) for Dietary Supplement Components.
