SB245 Alabama 2019 Session

Summary

Primary Sponsor

Tom ButlerSenator

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

SB 245 allows Alabama licensed pharmacists to substitute interchangeable biosimilar biological products for prescribed biological drugs under defined conditions, with notice and labeling requirements.

What This Bill Does

It defines biological products and interchangeable biological products, and adds a rule authorizing pharmacists to substitute a less expensive interchangeable product when allowed by the prescriber. Substitution is allowed for in-state prescribers who expressly authorize it, and for out-of-state prescribers who do not prohibit substitution. The bill requires two signature lines on written prescriptions to indicate brand and substitution permission, and requires instructions on oral/electronic prescriptions about substitution. Pharmacists must inform patients prior to dispensing the substitute, notify the prescriber within 24 hours if substitution occurs, and record the substituted product on the prescription and labeling must show the actual product dispensed.

Who It Affects

• Patients receiving biological drug products: may receive a substituted interchangeable product if allowed, and must be informed; the label will show the actual product dispensed.
• Licensed pharmacists: may substitute interchangeable biological products when permitted, must inform patients, notify prescribers within 24 hours, and document the substitution on the prescription and label.
• Prescribers (physicians and other practitioners): must indicate substitution permission on written prescriptions (via signature lines) or via instructions on oral/electronic prescriptions; must be informed if substitution occurs.
• Medicaid program: substitution is not allowed if Medicaid determines the prescribed biologic is lower in net cost after rebates.
• Alabama State Board of Pharmacy: oversees definitions and rules related to this act, and cannot adopt rules that would undermine the act; may provide reflects of an FDA interchangeable products list.

Key Provisions

• Defines BIOLOGICAL PRODUCT and INTERCHANGEABLE BIOLOGICAL PRODUCT as used in the bill, aligning with federal standards and Orange Book references.
• Adds Section 34-23-8.1 authorizing licensed pharmacists to substitute for prescribed biological products with conditions and notice provisions.
• Substitution authority: in-state prescribers who expressly authorize substitution; out-of-state prescribers who do not prohibit substitution.
• Written prescriptions require two signature lines to distinguish brand vs. substitution permission; oral/electronic prescriptions must include substitution instructions.
• Pharmacists must inform the patient prior to dispensing a substituted product and must notify the prescriber within 24 hours with the product name and manufacturer by approved communication methods.
• Pharmacists must record the substituted product on the prescription, and labels must display the actual product dispensed (brand name or biosimilar name from the Purple Book and manufacturer).
• Board may maintain a link to FDA’s list of interchangeable biological products; no new rules may override this section’s subject matter.
• Medicaid substitution exception: cannot substitute for a biologic prescribed to a Medicaid recipient if the prescribed biologic is lower in net cost after rebates.
• Effective date: becomes law on 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