Can Subutex® or Suboxone® or approved generic versions of these products be prescribed for conditions other than opioid addiction, e.g., pain control?
Subutex® and Suboxone® or approved generic versions of these products have received FDA approval only for the treatment of opioid addiction. However, once approved, a drug product may be prescribed by a licensed physician for any use that, based on the physician’s professional opinion, is deemed to be appropriate. Neither the FDA nor the Federal government regulates the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label. Off-label use is not illegal, but it means that the data to support that use has not been independently reviewed by the FDA. Information on FDA policy regarding off-label use of pharmaceuticals is available on the FDA Web site, http://www.fda.gov/cder/cancer/tour.htm, or http://www.fda.gov/cder/present/diamontreal/regappr/index.htm Physicians and other practitioners who are authorized to prescribe Schedule III controlled narcotic medications under Federal and State laws are eligible an
Related Questions
- Are there exceptions when Subutex and Suboxone or approved generic versions of these products may be administered by a practitioner without the DATA 2000 waiver?
- Can Subutex® or Suboxone® or approved generic versions of these products be prescribed for conditions other than opioid addiction, e.g., pain control?
- Are Subutex® and Suboxone® or approved generic versions of these products available in pharmacies?
