“Off-Label" Use of Marketed Drugs, Biologics and Medical Devices
Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.
FDA Off-label is defined as: The permissible use of an approved drug or instrument in a way that has not been specifically sanctioned. For more information, visit www.fda.gov/OC/OHRT/IRBS/offlabel.html.