Department of Health and Human Services, Food and Drug Administration:

Over-the-Counter Human Drugs and Labeling Requirements

OGC-99-36: Published: Apr 1, 1999. Publicly Released: Apr 1, 1999.


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Pursuant to a legislative requirement, GAO reviewed the Food and Drug Administration's (FDA) new rule on over-the-counter human drugs and labeling requirements. GAO noted that: (1) the rule would establish a standardized format and standardized content requirements for the labeling of over-the-counter drug products; (2) the final rule has an announced effective date of April 16, 1999, which is less than the 60-day delay in a major rule's effective date required by the Small Business Regulatory Enforcement Fairness Act; and (3) FDA, with the exception of the failure to allow the 60-day delay, complied with the applicable requirements in promulgating the rule.

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