Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled "Toll- Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide." This guidance is intended to help small businesses understand and comply with the requirements of the final rule regarding labeling of drugs with a toll-free number for adverse event reporting, which was published in the Federal Register on October 28, 2008 (final rule). The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. FDA prepared this guidance in accordance with the Small Business Regulatory Fairness Act.