HB499 Alabama 2019 Session

Summary

Primary Sponsor

Ron Johnson

Republican

Session

Regular Session 2019

Title

Pharmacists, biological drug products, substitution with interchangeable biological products as defined, Sec. 34-23-8.1 added; Sec. 34-23-1 am'd.

Summary

HB 499 would let licensed Alabama pharmacists substitute interchangeable, less expensive biological products for prescribed biological products under certain conditions, with required notices and labeling.

What This Bill Does

If the prescriber authorizes substitution, a pharmacist can dispense a less expensive interchangeable biological product instead of the prescribed product. Written prescriptions must have two signature lines to indicate 'dispense as written' or 'product selection permitted,' and oral or electronic prescriptions must indicate whether substitution is allowed; pharmacists must inform the patient before dispensing and record the exact product dispensed on the label. The pharmacist must notify the prescriber within 24 hours of any substitution and the act includes penalties for violations, with the law applying only to biological drug products.

Who It Affects

• Licensed Alabama pharmacists who may substitute interchangeable biological products and must follow notification and labeling rules.
• Physicians/practitioners who prescribe biological products and Alabama patients who receive them, as substitutions may be authorized and must be communicated and labeled accordingly.

Key Provisions

• Defines biological product and interchangeable biological product, and limits the act to biological drug products.
• Adds new section 34-23-8.1 authorizing licensed pharmacists to substitute for prescribed biological products under specified conditions.
• Interchangeable biological products can be substituted when the prescriber allows it or when an out-of-state prescriber does not prohibit substitution.
• Prescriptions must include substitution instructions: written prescriptions have two signature lines for 'dispense as written' and 'product selection permitted'; oral/electronic prescriptions must indicate substitution capability.
• Pharmacists must inform patients about substitutions before dispensing and record the actual product dispensed on the prescription and label.
• Pharmacists must notify the prescribing physician within 24 hours of substitution and by the same method used to transmit the prescription if possible.
• Pharmacists must provide the name and manufacturer of the substituted product to the prescriber and maintain records of the product dispensed.
• Label on the dispensing container must show the actual biological product dispensed and its manufacturer.
• The Alabama State Board of Pharmacy may not adopt rules altering this subject matter and may include a current list of interchangeable products (Purple Book) on its site.
• Violation of these provisions carries a fine of up to $1,000.

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

Subjects

Health