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Get A Guidance For Small Business Entities - Gpo

Nce for small business entities entitled Toll-Free Number Labeling and Related Requirements for Over-theCounter and Prescription Drugs Marketed With Approved Applications; Small Entity Compliance Guide. This guidance summarizes the final rule published in the Federal Register of October 28, 2008 (73 FR 63886), which requires the labeling of each human drug product for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include:.

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