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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.

The noteworthy "Flag the Label" program has been adopted by members of the Consumer Healthcare Products Association to aid in alerting consumers to significant changes in nonprescription medicines.

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.

The purpose of these guidelines is to catalog and strengthen standards of care that have evolved in the practice of providing unsolicited free samples of OTC medicines to consumers to promote their products.

Manufacturers have developed an anti-smurfing educational program for the retail setting that is voluntary and offered to retailers at no cost. The intent is to educate potential illegal purchasers about related criminal penalties and how the real-time, stop-sale system works.

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.

The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.

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.

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.