U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Requirements for All OTC Products
Adverse Event Reporting Requirements

We also want to point out that just as drug products with approved applications are subject to post-marketing adverse event reporting requirements, so are nonprescription human drug products marketed under the OTC Drug Review without an approved application.

What does this mean? FDA recently announced implementation of two statutory amendments affecting OTC drug products. Let's look at each of these amendments in more detail.

Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application (as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act)

Toll-Free Number Interim Final Rule (Food and Drug Administration Amendments Act of 2007)

Flowchart with top box labeled Adverse Event Reporting Requirements. Two arrows point away from this box. One points to a circle labeled Action 1. The other points to a circle labeled Action 2.
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