AB 389 Summary

• Establishes the Standards of Service for Providers of Blood Clotting Products for Home Use Act, requiring pharmacies dispensing blood clotting factors for hemophilia and other bleeding disorders to meet specified service standards.

• Mandates providers maintain 24/7 on-call service, respond to emergency calls within one hour, deliver non-emergency prescriptions within two business days, and deliver emergency prescriptions within 12 hours (or one day for remote patients).

• Requires providers to stock multiple brands and assay ranges of FDA-approved blood clotting products, supply ancillary infusion equipment and supplies, maintain proper storage standards, and provide language interpretation services.

• Obligates providers to notify patients of product recalls within 24 hours, maintain HIPAA-compliant recordkeeping, and develop disaster response plans.

• Designates the California State Board of Pharmacy to administer and enforce the law, with exemptions for hospital and health system pharmacies dispensing products only for emergency or inpatient situations.