THE SENATE

S.B. NO.

473

THIRTY-SECOND LEGISLATURE, 2023

S.D. 1

STATE OF HAWAII

 

 

 

 

 

 

A BILL FOR AN ACT

 

 

RELATING TO THE PRACTICE OF PHARMACY.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


     SECTION 1.  Chapter 461, Hawaii Revised Statutes, is amended by adding a new section to be appropriately designated and to read as follows:

     "§461-    Distribution of dialysate drugs and devices.  (a) The license, registration, and permit requirements of this chapter shall not apply to a drug manufacturer, wholesale prescription drug distributor, or third-party logistics provider, to the extent the manufacturer, wholesale distributor, or third-party logistics provider is engaged in the distribution of dialysate drugs or devices necessary to perform home dialysis on patients with end-stage renal disease; provided that the following criteria are met:

     (1)  The dialysate drugs or devices are approved by the United States Food and Drug Administration, as required by federal law;

     (2)  The dialysate drugs or devices are lawfully held by a manufacturer or a manufacturer's agent that is properly registered with the board as a manufacturer or wholesale distributor;

     (3)  The dialysate drugs or devices are held and delivered in their original, sealed, and labeled packaging from the manufacturing facility;

     (4)  The dialysate drugs or devices are delivered only by the manufacturer or the manufacturer's agent and only upon receipt of a physician's order; and

     (5)  The manufacturer or the manufacturer's agent delivers the dialysate drugs or devices directly to a:

          (A)  Patient with end stage renal disease, or the patient's designee, for the patient's self-administration of dialysis therapy; or

          (B)  Health care provider or institution for administration or delivery of dialysis therapy to a patient with end stage renal disease.

     (b)  For the purposes of this section:

     "Manufacturer" shall have the same meaning as in section 328-112.

     "Third-party logistics provider" means an entity that provides or coordinates warehousing or other logistics services on behalf of a pharmaceutical manufacturer, wholesale distributor, or dispenser of a product.

     "Wholesale distributor" shall have the same meaning as in section 328-112."

     SECTION 2.  New statutory material is underscored.

     SECTION 3.  This Act shall take effect on December 31, 2050.


 


 

Report Title:

Pharmacy; Dialysis Drugs and Supplies; Manufacturers; Wholesalers; Third-Party Logistics Providers; Exemption

 

Description:

Exempts drug manufacturers, wholesale prescription drug distributors, and third-party logistics providers of home dialysis drugs, supplies, and devices from the license, registration, and permit requirements for pharmacies; provided that certain conditions are met.  Effective 12/31/2050.  (SD1)

 

 

 

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