To amend chapter 338, RSMo, by adding thereto one new section relating to pharmaceutical delivery of drugs and devices necessary to treat chronic kidney failure.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF MISSOURI,

AS FOLLOWS:

Section A. Chapter 338, RSMo, is amended by adding thereto one new section, to be known as section 338.425, to read as follows:

338.425. 1. This section shall be known and may be cited as the "Missouri Kidney Health Care Act".

2. Notwithstanding any provisions of the law to the contrary, a manufacturer or wholesaler who supplies dialysis devices or drugs used exclusively for or necessary to perform home dialysis prescribed or ordered by a physician for administration or delivery to a person with chronic kidney failure shall not be considered to be practicing pharmacy without a license if:

(1) The manufacturer or wholesaler is registered with the state board of pharmacy and lawfully holds the dialysis drugs or devices;

(2) The manufacturer or wholesaler delivers the dialysis drugs or devices to:

(a) A person with chronic kidney failure for self-administration, as ordered by a physician, at the person's home or specified address; or

(b) A physician for administration or delivery to a person with chronic kidney failure; and

(3) The manufacturer or wholesaler has sufficient and qualified supervision to adequately protect the public health.

3. The state board of pharmacy shall promulgate rules and regulations necessary to ensure the safe distribution of the dialysis drugs and devices described in subsection 2 of this section, without interruption of supply. Such regulations shall include licensing, records, evidence of delivery to the patient or patient's designee, patient training, specific product and quantity limitation, physician prescriptions or order forms, adequate warehouse facilities and appropriate labeling to ensure necessary information is affixed to or accompanies such dialysis drugs or devices.

4. If the state board of pharmacy finds any dialysis drugs or devices distributed pursuant to this section to be ineffective or unsafe for their intended use, the board may institute immediate recall of any or all of such dialysis drugs or devices distributed to individual patients under the authority to this section.

5. The dialysis drugs or devises which are the subject of this section shall only be delivered by:

(1) The manufacturer or wholesaler to which the physician has issued an order; or

(2) A carrier authorized to possess such dialysis devices or drugs.

6. No rule or portion of a rule promulgated under the authority of this section shall become effective unless it has been promulgated pursuant to the provisions of section 536.024, RSMo.