Title 48 — Foods and Drugs.

This chapter may be cited as the “Off-Label Informed Consent Act of 2008”.

For the purposes of this chapter, the term: (1) “FDA” means the federal Food and Drug Administration. (2) “Off-label use” means the use of a prescription drug for human use to treat a condition that is not included in the labeling for that medication, as approved by the federal F…

Before prescribing, administering, or furnishing a prescription medication for an off-label use, a prescriber shall make every reasonable effort to: (1) Explain to the patient, in easily understood terms, that the medication is not within the uses approved for that medication by …

Failure to comply with this chapter may be used by a health-occupation board as a factor when determining licensure status for a prescriber; provided, that a prescriber shall not be subject to an adverse licensure action if the Board of Medicine determines that the prescribing, a…