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October 22, 1997

FDA Sets Geriatric Drug Use Labeling Deadlines

JAMA. 1997;278(16):1302. doi:10.1001/jama.1997.03550160022010

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THE FOOD and Drug Administration (FDA) has published its final rule requiring the labeling of pharmaceuticals to include information pertinent to their appropriate use by elderly patients (aged 65 years or older). Although the rule becomes effective 1 year from the date of its publication in the August 27, 1997, Federal Register (62 Federal Register 45313-45326), its implementation will occur in stages over a 5-year period.

The rule will require manufacturers to include a "Geriatric Use" subsection within the "Precautions" information of a drug's labeling. This subsection must describe what is known about the effects of a drug in the elderly and list any limitation, hazard, or monitoring need associated with geriatric use. Specific geriatric indications, if any, must be described in the "Indications and Usage" section and specific geriatric dosing instructions are to be described in the "Dosage and Administration" section. Also, if specific pharmacokinetic or pharmacodynamic studies of