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Prescription Drugs For Off-label Use

Concerning the authorization of prescription drugs approved by the federal food and drug administration for off-label use.
2023 Regular Session
Professions & Occupations
Bill Summary

The bill authorizes a physician, a physician assistant, and an advanced practice registered nurse licensed health-care professional who is authorized to prescribe drugs (prescriber) to prescribe and administer a drug approved by the federal food and drug administration (FDA) for an off-label use. if:

  • The off-label use of the drug for the indication has longstanding, common use;
  • There is medical evidence to support the off-label use and no known evidence contraindicating such off-label use; and
  • The prescriber has provided the patient or a minor patient's parent or guardian with an informed consent form, and the patient or parent or guardian has signed the form.

The bill applies the same standard of care for the off-label use of the drug as for the on-label use of the drug.

The bill clarifies that:

  • The prescription and administration of an FDA-approved drug for an off-label use is not, by itself, a grounds for discipline; and
  • A pharmacist who fills a prescription for off-label use is not subject to discipline by the state board of pharmacy.

(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)

(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)




Bill Text

The effective date for bills enacted without a safety clause is August 7, 2024, if the General Assembly adjourns sine die on May 8, 2024, unless otherwise specified. Details