Published on the Packaging World Web site
| September 30, 1997
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.
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.
© Copyright 2014 Summit Media Group, Inc. This copy is for your personal, noncommercial use only. To order presentation-ready copies for distribution to your colleagues, clients or customers click HERE
or use the "Reprints" tool that appears next to any article. Visit www.summitreprints.com
for samples and additional information. Order a reprint or license this article now.