HB354 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 354 allows Alabama pharmacists to substitute a prescribed biological product with a less expensive interchangeable biological product under certain conditions, with required notices and labeling.

What This Bill Does

The bill authorizes licensed pharmacists to substitute a prescribed biological product with a less costly interchangeable biological product if allowed by the prescriber and if the product is deemed interchangeable by federal standards. It requires specific prescription language on written prescriptions and explicit instructions on oral/electronic prescriptions, plus notification to the patient before dispensing. Pharmacists must notify the prescriber within 72 hours of substitution and record the actual product dispensed on the prescription form and label. It also includes labeling requirements, a list of interchangeable products, penalties for violations, and states the act applies only to biological drug products.

Who It Affects

• Pharmacists licensed in Alabama, who may substitute interchangeable biological products and must follow notification, labeling, and record-keeping requirements.
• Prescribers (physicians and other practitioners) who issue biological product prescriptions, and patients who receive substituted products; substitutions require prescriber authorization and patient notification.

Key Provisions

• Defines biological product and interchangeable biological product, and adds Section 34-23-8.1 authorizing substitutions under defined conditions.
• Written prescriptions must include two signature lines: one for 'dispense as written' and one for 'product selection permitted'; oral/electronic prescriptions must include substitution instructions.
• Pharmacists may substitute with a less expensive interchangeable product only when the prescriber authorizes it; substitutions involving out-of-state prescribers are allowed if not expressly prohibited by the out-of-state rules.
• Pharmacists must inform the patient prior to dispensing the substituted product and notify the prescriber within 72 hours with the product name and manufacturer; any substitution must be documented on the prescription form.
• Prescription labels must show the actual product dispensed (brand or Purple Book biosimilar) and a board link to the list of interchangeable products may be provided.
• Violations can result in a fine up to $1,000; the act applies only to biological drug products; the Board of Pharmacy cannot adopt rules altering this subject.
• 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

Health