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  • Title: Over-the-counter human drugs; labeling requirements; final rule; technical amendment. Food and Drug Administration, HHS. Final rule; technical amendment.
    Journal: Fed Regist; 2000 Jan 03; 65(1):7-9. PubMed ID: 11010625.
    Abstract:
    The Food and Drug Administration (FDA) is amending the regulation that established a standardized format and standardized content requirements for the labeling of over-the-counter (OTC) drug products, and is amending several related OTC drug product labeling regulations. This amendment corrects and conforms several aspects of the new labeling requirements to other regulatory provisions and eliminates unnecessary text from the new labeling regulation.
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