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Correspondence  |   November 1999
“Label”Versus “Labeling” of a Drug: There is a Significant Difference 
Author Notes
  • Department of Anesthesiology
  • Brigham & Women's Hospital
  • Boston, Massachusetts 02115
Article Information
Correspondence
Correspondence   |   November 1999
“Label”Versus “Labeling” of a Drug: There is a Significant Difference 
Anesthesiology 11 1999, Vol.91, 1556. doi:
Anesthesiology 11 1999, Vol.91, 1556. doi:
In Reply:—
Although industry and the Food and Drug Administration itself commonly use the words label  and off-label  1 when referring to the package insert, Dr. Moore is correct in stating that Federal Regulations define the label as wording appearing on a carton, bottle, syringe, or ampule.
Reference 
Reference 
FDA proposes rules for dissemination information on off-label uses. HHS News, June 5, 1998