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News From the Food and Drug Administration
January 6, 1999

New Requirement for Patient Labeling for Selected Prescription Drug Products

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999American Medical Association

JAMA. 1999;281(1):27. doi:10.1001/jama.281.1.27-JFD80012-2-1

The FDA has issued a final rule establishing requirements for the distribution of patient labeling for selected prescription drug and biological products used primarily on an outpatient basis. The agency is requiring the distribution of patient labeling, called Medication Guides, for a small number of products that the agency believes pose a serious and significant public health concern necessitating this distribution. The agency will require Medication Guides if one or more of the following circumstances exists: (1) the product is one for which labeling could help prevent serious adverse effects or (2) the product has serious risks that could affect patients' decision to use, or to continue to use, the product or (3) the product is important to health and patient adherence to directions for use is crucial to the drug's effectiveness.