Unlabeled Use of Drug

50.4.2 - Unlabeled Use of Drug (Rev. 1, 10-01-03) B3-2049.3 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 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 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. In the case of drugs used in an anti-cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in §50.5. These decisions are made by the MAC on a case-by-case basis.