HB82 Alabama 2017 Session

Updated Feb 26, 2026

Notable

Summary

Primary Sponsor: Ron Johnson
Republican
Session: Regular Session 2017
Title: State Bd. of Pharmacy, licensed pharmacists authorized to dispense interchangeable or therapeutically equivalent substitutes for biological products, Secs. 34-23-1, 34-23-8 am'd.
Summary: HB82 would let licensed Alabama pharmacists substitute FDA-approved interchangeable biological products for prescribed biological products, with notice to patients and required documentation.
What This Bill Does
If passed, the bill would authorize pharmacists to substitute interchangeable or therapeutically equivalent biological products for what is prescribed, when allowed by the prescriber. It requires the pharmacist to inform the patient, record the product dispensed, and notify the prescriber within five business days (through electronic systems or other approved methods) unless no interchangeable product exists or the prescription isn’t changed on a refill. It also mandates two signature lines on written prescriptions to indicate whether substitution is permitted, requires labeling to show the actual product dispensed, and directs the board to maintain a current FDA-listed list of interchangeable biological products; penalties for violations include fines up to $1,000.

Who It Affects
Licensed pharmacists in Alabama, who would be permitted to substitute interchangeable biological products when authorized by the prescriber and who must document and communicate substitutions.
Prescribers (in-state and out-of-state) who authorize or prohibit substitutions; their instructions help determine when substitutions can occur and how substitutions are communicated.
Patients receiving biological products, who would be informed about substitutions and receive products with labeling identifying the actual product and manufacturer.
Pharmacies and the Alabama State Board of Pharmacy, which would manage records, patient notices, prescriber communications, and maintain the list of FDA-interchangeable biological products.

Key Provisions
Defines 'interchangeable biological product' consistent with FDA standards (k4) or therapeutically equivalent determinations.
Permits substitution of a prescribed biological product with a less expensive pharmaceutically and therapeutically equivalent product or an interchangeable biological product when the prescriber authorizes it.
Requires the pharmacist to inform the patient of the substitution and record the specific product dispensed on the prescription, including manufacturer.
Within five business days, requires electronic or other prescribed communication to the prescriber about the product dispensed, with exceptions if no interchangeable product exists or for unchanged refills.
Written prescriptions must have two signature lines to indicate whether substitution is permitted or dispense-as-written, with instructions from the prescriber honored.
Labels must indicate the actual drug or biological product dispensed and the manufacturer.
The Board must provide a current link to FDA-approved interchangeable biological products and may impose a permissible penalty (up to $1,000) for violations.
Effective date: the first day of the third month after passage and approval.

AI-generated summary using openai/gpt-5-nano on Feb 24, 2026. May contain errors — refer to the official bill text for accuracy.
Subjects: Pharmacy, Alabama State Board of