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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.

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Learn more about the issues CHPA addresses in the OTC medicine, dietary supplement, and consumer medical device industries.

As a direct result of the PROTECT initiative, CHPA developed a voluntary guideline for industry suggesting ways to standardize volumetric measures in dosing directions and dosing devices for oral pediatric liquid drug products.

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.

To help prevent accidental medication ingestions and overdoses in children, this document suggests ways to improve the consistency and standard format of volumetric measures within the dosing directions on the outer packaging and immediate container label.

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.

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