HB354 Summary

• Amends Alabama pharmacy law to define "biological product" (per 42 U.S.C. §262) and "interchangeable biological product" (FDA-approved as interchangeable or therapeutically equivalent per Orange Book standards).

• Authorizes licensed pharmacists to substitute less expensive interchangeable biological products for prescribed brand-name biologicals when practitioners allow it via two-signature prescription lines ("dispense as written" or "product selection permitted").

• Requires pharmacists to notify patients before dispensing a substitute and inform prescribing physicians within 72 hours of any substitution, including the product name and manufacturer.

• Mandates prescription labels show the actual biological product dispensed and establishes the State Board of Pharmacy may maintain a website link to FDA's current interchangeable biological products list.

• Applies exclusively to biological drug products and penalizes violations with fines up to $1,000; becomes effective the first day of the third month following passage.