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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.

The Standardized Information on Dietary Ingredients (SIDITM) Protocol is intended to serve as a standardized format that can be used consistently across the dietary supplement industry.

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.

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.

This white paper provides guidance for the evaluation and reporting of impurities in OTC monograph drug products formulated as topicals and topical rinses. This document serves as CHPA's member company consensus on this complex issue.