Off-label use of drugs and devices may have legal consequences to the physician. When planning to use a drug or device in a situation that does not have specific FDA approval, it would be prudent to have medical literature to support the use, a record of all reasons for off-label use, and an accurate record of the results of the use.
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References
1.
21 USCS § 360 (Federal Food, Drug, and Cosmetic Act).
2.
FDA Drug Bulletin12(1):4–5, April, 1982.
3.
Reeves v AcroMed Corporation, 1995 WL 29058, 44 F 3d 300 (5th Cir 1995).
4.
21 USCS § § 301 et seq. (Medical Device Amendments).
