HB5581 Summary

• Amends the Pharmacy Practice Act to allow substitution of biosimilar products determined interchangeable by the FDA, provided manufacturers submit interchangeability information to the Illinois Department of Public Health no later than 60 days before product substitution in the state.

• Requires prescription forms to include a signature line with "may not substitute" language that prescribers must mark by hand to prohibit biosimilar substitution; preprinted or rubber-stamped marks are not permitted.

• Allows pharmacies to substitute biosimilar products only when the FDA deems them interchangeable, the prescriber does not prohibit substitution in writing, the patient provides written consent, the prescriber is notified within 24 hours, and both pharmacy and prescriber maintain written records for at least 5 years.

• Requires the Illinois Board of Pharmacy to adopt rules establishing civil monetary penalties for violations of biosimilar substitution requirements and adds violation of biosimilar provisions to the list of grounds for Department disciplinary action.

• Directs the Department of Public Health to maintain a public website listing all FDA-interchangeable biosimilar products; effective January 1, 2013.