Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled "Labeling OTC Human Drug Products; Small Entity Compliance Guide." FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency's over- the-counter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004.