Sailing the straits of approval: the nature of FDA approval and its implications for surgeons.

Use of Food and Drug Administration-approved medications and products for other than the approved indications is common in facial plastic surgery and violates no laws. Addressing practical concerns about such use strengthens the doctor-patient relationship and can minimize the risk of successful allegations of negligence in the event of untoward outcomes. The facial plastic surgeon can find support and assistance with off-label use in two general areas. Abundant scientific literature focuses on off-label use and addresses its practical, scientific, legal, moral, and ethical issues. The Food and Drug Administration also addresses off-label use in its own publications. It offers guidelines for physicians that, if followed, facilitate incorporation of off-label use into practice with minimal risk and maximum potential for therapeutic success.