Pharmacy Times
Volume 0

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

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

The National Association of Chain Drug Stores (NACDS) hasbeen working closely with the FDA on the impact of the newside-effect requirements. NACDS President and Chief ExecutiveOfficer Steven C. Anderson, IOM, CAE, noted that "ensuring thehealth and well-being of our pharmacy patients is the highestpriority," and "we look forward to continuing to work with theFDA over the next year to help chain pharmacies meet therequirements by next January."

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