SB 23-041

Senate Bill 23-041, also known as the Prescription Drugs for Off-label Use bill, allows doctors and other healthcare professionals to prescribe FDA-approved medications for uses that are not officially approved by the FDA, but have been commonly used and supported by medical evidence. This means patients can receive treatments that aren't listed on the drug's official label if their doctor believes it is safe and effective. The bill also protects both prescribers and pharmacists from disciplinary action as long as they provide informed consent to the patient or their guardian. The bill has been signed into law, meaning healthcare providers in Colorado are now legally allowed to prescribe drugs for off-label use under certain conditions, without fear of punishment if they follow these guidelines.

Official 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.)

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