Off-label use of a medication is a use that is not included as an indication on the medication's label as approved by the Food and Drug Administration (FDA). FDA-approved medications used for indications other than what is indicated on the official label may be covered under Medicare if the carrier 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 medications used in an anti-cancer chemotherapeutic regimen, unlabeled uses are covered for a medically accepted indication as defined in the Medicare Carriers Manual, Section 2049.4.C.