Labeling for other drugs will follow a schedule depending upon the date on which its license was first approved. The oldest drugs (those approved before 1963) will be the last to be labeled. The geriatric use section will appear within the Precautions information on the label. It will describe known effects of the drug on the elderly and list any limitations, hazards, or monitoring needs associated with use by the elderly.
Labeling for geriatrics
All pharmaceutical drug labels must include a geriatric use subsection according to a final rule published in late August by FDA. Geriatric labeling will be phased in through 2003, beginning with six priority drug categories which must be labeled by August 28, 1998.
Sep 30, 1997
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