FDA requires new toll-free number for reporting adverse events

January 4, 2008

New rule requires pharmacies to provide patients with a toll-free number to report adverse events.

As of Jan. 1, FDA is requiring a toll-free number to be listed on the labeling of human drugs for the reporting of adverse events. The number is to be used only for reporting side effects and not for seeking medical advice. This interim final rule, published in the Jan. 3 Federal Register, does not apply to over-the-counter drugs if the product packaging includes a manufacturer’s or distributor’s toll-free number for reporting complaints. Realizing that manufacturers and pharmacies will need time to update their labeling to comply with this new requirement, FDA said it would not take enforcement action on this matter until Jan. 1, 2009. The agency added that the side effect statement has to be distributed by pharmacists with each new and refill prescription either through a sticker on the unit package, vial, or container; a preprinted Rx vial cap; a separate sheet of paper; consumer medication information; or a medication guide.

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