SB396 Alabama 2016 Session

Summary

Primary Sponsor

Tom Whatley

Republican

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

This bill would exempt certain home dialysis supply distributors from Alabama Pharmacy Board regulation if they meet specific safety and delivery requirements.

What This Bill Does

It creates an exemption (Section 34-23-77) for facilities that only distribute dialysate, drugs, or devices used for home renal dialysis for chronic kidney failure, from regulation by the Alabama State Board of Pharmacy, provided they meet criteria. The criteria require FDA-approved or FDA-cleared products, items held by a properly registered manufacturer or wholesaler, delivery in original sealed packaging, delivery only by the manufacturer or their agent upon a physician's order, and direct delivery to the patient or a health care provider/institution for administration. The act becomes effective on the first day of the third month after governor’s approval.

Who It Affects

• Facilities that distribute only dialysate, drugs, or devices for home renal dialysis and meet all criteria would be exempt from Alabama State Board of Pharmacy regulation.
• Manufacturers or their agents who hold and deliver these products (must be registered with the Board as manufacturer/wholesaler) and the patients or health care providers receiving the supplies (delivered directly from manufacturer/agent upon a physician order in original packaging).

Key Provisions

• Adds Section 34-23-77 to exempt certain home dialysis supply distributors from regulation by the Alabama State Board of Pharmacy if criteria are met.
• Criteria include: (1) FDA-approved/cleared products; (2) held by a properly registered manufacturer/wholesaler; (3) original, sealed packaging; (4) delivery only by manufacturer or agent and only with a physician's order; (5) direct delivery to the patient or designee or to a health care provider/institution for administration.
• Effective date: first day of the third month following passage and governor’s 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