The FDA confirmed the interim final rule “ Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products. The rule requires a toll-free number on labeling for drugs subject to FDC Act §505. The required statement must include a toll-free number for reporting complaints to the manufacturer and advise that the number is only for reporting side effects and is not for getting medical advice; this is known as the “side effects statement. The labeling of all prescription drugs must include the side effects statement, but only those over-the-counter (OTC) drugs whose packaging does not already include a toll-free number must add the new side effects statement. The final rule is effective November 28, 2008, but the compliance date will be delayed until until July 1, 2009, due to the economic impact on manufacturers who must amend labeling, to give them ample time to comply.
SOURCE: FDA Order
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