The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
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.
Explore our list of resources to learn more about the dietary supplement category and how it is regulated by the U.S. Food and Drug Administration and Federal Trade Commission.
Regulation of Dietary Supplements covers marketing, manufacturing, labeling, and advertising enforced by FDA and the Federal Trade Commission. See these FAQs to learn more.
Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.
The Standardized Information on Dietary Ingredients (SIDI) Work Group has released three voluntary guidelines, intended to help the dietary supplement industry comply with cGMP regulations.
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.
