Published Online: Friday, February 1, 2008

Pharmacies have been given until January 1, 2009, to comply with an FDA ruling that requires a toll-free number for reporting drug side effects on the labeling of new and refill prescriptions and OTC products dispensed in an outpatient setting.

The FDA's interim rule is designed to codify the proposed rule entitled "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective on January 1. The rule requires that drug products for which applications have been approved include a toll-free number on the label only for reporting adverse events; it is not intended for seeking medical advice. As mandated by the FDAAA, the interim final rule does not apply to OTC products approved as new drugs if their product packaging already includes a toll-free number for reporting complaints to the manufacturer or drug distributor.

The National Association of Chain Drug Stores (NACDS) has been working closely with the FDA on the impact of the new side-effect requirements. NACDS President and Chief Executive Officer Steven C. Anderson, IOM, CAE, noted that "ensuring the health and well-being of our pharmacy patients is the highest priority," and "we look forward to continuing to work with the FDA over the next year to help chain pharmacies meet the requirements by next January."

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