Glossary Term: Off Label

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The Pharma Marketing Glossary
Off Label

Similar or Alternative Terms Meaning the Same Thing Off-label communication, Off-label use, Unlabeled use

Related Term(s) n/a

Definitions

FDA defines off label use as, "Use for indication, dosage form, dose regimen, population or other use parameter not mentioned in the approved labeling."
"FDA recognizes that off label use of drugs by prescribers is often appropriate and may receive endorsement from published literature; they may also receive recommendations as 'Other standard uses - i.e., recommended by subspecialty societies, CDC, etc.' "
Source: FDA.

"An unlabeled use [off-label use] of a drug is a use that is not included as an indication on the drug's label as approved by the FDA."
Source: Medicare.

Article: "Guidelines for Off-label Communications," Pharma Marketing News, Vol. 2, #11; REPRINT #211-05.

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