Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-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 "Organ Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use--Small Entity Compliance Guide." This guidance is intended to help small businesses understand and comply with FDA's regulation entitled "Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Final Monograph" (74 FR 19385, April 29, 2009).\1\ The guidance describes the organ-specific labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act. ---------------------------------------------------------------------------