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Frequently Asked Questions for Pharmacists on Reporting Adverse Drug Effects

Q: Does the FDA require pharmacists to provide patients with a toll-free number to report adverse drug effects?

A: Yes. Effective January 1, 2008, pharmacists are required to distribute with all prescriptions information alerting patients that they may call a toll-free telephone number to report adverse drug effects to the FDA. The final rule provides a number of ways by which this requirement can be accomplished. The text of the rule may be found here.

To report a problem to the FDA, call 1-800-332-1088.

Submit your report online here: or here:


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