Pharmacy Question for the Week of September 23, 2019

Pharmacy Compliance Question of the Week


What is an unlabeled use of a drug?


According to the Medicare Benefits Policy Manuel:

“An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the Food and Drug Administration (FDA). FDA approved drugs used for indications other than what is indicated on the official label may be covered under Medicare if the A/B Medicare Administrative Contractor (MAC) (B) determines the use to be medically accepted, taking into consideration the major drug compendia, authoritative medical literature and/or accepted standards of medical practice.”