HB 499 Summary

• Amends Alabama pharmacy law to define "biological product" (as defined in 42 U.S.C. §262) and "interchangeable biological product" (products approved by FDA for interchangeability or therapeutic equivalence per the Orange Book).

• Authorizes licensed pharmacists to substitute less expensive interchangeable biological products for prescribed brand-name biologics when the prescriber expressly permits such substitution on written prescriptions or verbal/electronic prescriptions.

• Requires written prescriptions to include two signature lines: one for "dispense as written" and one for "product selection permitted," with practitioners signing the appropriate line to communicate their authorization.

• Mandates pharmacists notify patients before dispensing a substituted biological product and inform the prescribing physician within 24 hours of the substitution via the same communication method used to transmit the original prescription.

• Requires pharmacists to record the actual biological product dispensed on the prescription form and label containers with the product name and manufacturer; violations subject to fines up to $1,000; applies only to biological drug products.