SB245 Summary

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

• Authorizes licensed pharmacists to substitute a less expensive interchangeable biological product for a prescribed brand-name biological product when the prescriber expressly permits such substitution on written or oral prescriptions.

• Requires written prescriptions for biological products issued in Alabama to contain two signature lines—one for brand-only dispensing and one permitting product selection—and allows out-of-state prescribers' authorizations by default unless expressly prohibited.

• Mandates pharmacists notify patients prior to dispensing an interchangeable product and inform prescribing physicians within 24 hours (excluding Sundays and federal holidays) of any biological product substitution via electronic message, telephone, or facsimile.

• Prohibits pharmacist substitution for Medicaid recipients when the Medicaid Agency determines the prescribed biologic product is lower in net cost after rebates, and restricts the State Board of Pharmacy from adopting rules that would contradict these provisions; act applies only to biological drug products.