HB260 Alabama 2016 Session

Summary

Primary Sponsor

Elaine Beech

Democrat

Session

Regular Session 2016

Title

Pharmacy, State Board of, facilities providing dialysate, drugs, or devices for home rental dialysis exempt from regulation, Sec. 34-23-77 added

Summary

HB260 would exempt certain home dialysis supply distributors from Alabama Board of Pharmacy regulation if they meet specific safety and delivery rules.

What This Bill Does

The bill creates an exemption from State Board of Pharmacy regulation for facilities that only distribute dialysate, drugs, or devices used for home renal dialysis to chronic kidney patients, provided they meet conditions. Those conditions require FDA approval or clearance, proper registration with the board as a manufacturer or wholesaler, original sealed packaging, and delivery directly by the manufacturer or their agent after a physician’s order. Deliveries must go directly to the patient or their designee, or to a health care provider or institution for administration. The exemption becomes effective on the first day of the third month after passage and governor approval.

Who It Affects

• Facilities that distribute dialysate, drugs, or devices for home dialysis to chronic kidney patients would be exempt from the Alabama State Board of Pharmacy's regulation if they meet the stated criteria.
• Patients with chronic kidney failure and their health care providers or institutions that receive or administer these supplies would be served by a system where delivery is controlled by the manufacturer or their agent upon physician order.

Key Provisions

• Adds Section 34-23-77 to exempt facilities engaged solely in the distribution of dialysate, drugs, or devices needed for home renal dialysis from regulation by the Alabama State Board of Pharmacy.
• Requires FDA approval or clearance for the products, as required by federal law.
• Requires products to be held by a manufacturer or their agent who is properly registered with the board as a manufacturer or wholesaler, and kept in original sealed packaging.
• Requires delivery to be performed only by the manufacturer or their agent, and only upon receipt of a physician's order, directly to the patient or designee, or to a health care provider or institution for administration.
• Effective date: the first day of the third month following passage and governor 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