Is it permissible to use the US licensed extracts for subcutaneous immunotherapy for SLIT, i.e. off-label use?
The off-label use of products is not illegal. You are responsible for knowing the indications (on or off label) as well as the risks and benefits of any product you use in treatment of a patient. While pharmaceutical companies are prohibited by law from advertising off-label use of any of their products, physicians may use any FDA approved products for any indication she/he thinks appropriate. There should be published literature substantiating the off-label use indication. Use of approved medications off-label should also include a thorough risk/benefit/alternative discussion with the patient and documentation of the discussion and mutual decision to pursue treatment.
