SB20 Alabama 2023 Session

Summary

Primary Sponsor

William “Bill” M. BeasleySenator

Democrat

Session

Regular Session 2023

Title

Relating to the Board of Pharmacy; to amend Section 34-23-32 of the Code of Alabama 1975, requiring a manufacturer, bottler, packager, wholesale drug distributor, and other entities in the supply chain for pharmaceutical products to obtain an annual permit from the board; to require each permit holder to designate a representative of the permit holder who would be required to register with the board; and to provide for an additional annual registration fee.

Summary

This bill would require every permit holder in Alabama's pharmaceutical supply chain to designate a representative who must register with the Board of Pharmacy and pay an additional annual registration fee, with updated fee schedules and stricter compliance rules.

What This Bill Does

It amends the Board of Pharmacy's rules to require each permit holder to designate a current representative and register that person with the board, with qualifications set by the board. It creates an initial representative registration fee of at least 100 and an annual renewal fee of at least 100, with renewal due by October 31 and penalties for late renewal. It also sets permit-related fees (new establishments 500-2000, renewals 250-1000, transfers 500-2000) and adds compliance measures for legend drugs, including prohibiting shipments into the state without a valid permit and imposing up to 4000 in civil penalties for violations, plus requiring a list of trading partners upon request. Additionally, the bill preserves existing permit requirements for employing a full-time licensed pharmacist (with wholesalers that only distribute being exempt) and establishes an effective date of January 1, 2024.

Who It Affects

• Permit holders in the pharmaceutical supply chain (manufacturers, bottlers, packagers, repackagers, third-party logistics providers, wholesale drug distributors, private label distributors, outsourcing facilities, and other listed entities) by requiring designation and registration of a representative and new registration fees.
• Public health and safety, by strengthening controls on the shipping of legend drugs and requiring verification of recipients and board-permit status to reduce unpermitted or unsafe drug shipments.

Key Provisions

• Amendment of 34-23-32 to require each permit holder to designate a current representative and register that representative with the board, with qualifications determined by the board.
• Initial registration fee for the designated representative of at least 100 and an annual renewal fee of at least 100; renewal due October 31; delinquency rules and penalties (up to 50 per month).
• Fee schedules for permits: new establishment 500-2000; renewal 250-1000; transfer of ownership 500-2000.
• Permit holders must employ a full-time licensed pharmacist for on-premise pharmaceutical operations (wholesale distributors that limit to distribution are exempt).
• No legend drug or device may be shipped into Alabama without a valid board-issued permit; violators may face a civil penalty of up to 4000 per violation; holder must provide a list of trading partners upon request.
• Permit recipients must verify that shipments go to licensed physicians or registered pharmacies; permits must be paid by December 31, with renewal due by October 31 and display of the permit in a conspicuous place.
• Effective date: January 1, 2024.

AI-generated summary using openai/gpt-5-nano on Feb 22, 2026. May contain errors — refer to the official bill text for accuracy.

Subjects

Pharmacy Board, permit holders, required to designate a representative, qualifications, fees