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THE SENATE |
S.B. NO. |
473 |
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THIRTY-SECOND LEGISLATURE, 2023 |
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STATE OF HAWAII |
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A BILL FOR AN ACT
relating to the practice of pharmacy.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
"§461- Distribution of dialysate drugs and devices.
(a) The license,
registration, and permit requirements of this chapter shall not apply to a
drug manufacturer, a wholesale prescription drug distributor, or a 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 peritoneal 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 the 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 upon its approval.
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INTRODUCED BY: |
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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.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.