S.D. Admin. R. 20:51:05:23

Current through Register Vol. 51, page 67, December 16, 2024

Section 20:51:05:23 - Distribution of dialysate by the manufacturer or manufacturer's agent to patient - Exemption from pharmacy licensure

A manufacturer or agent of a manufacturer of dialysate may ship dialysate directly to a patient in this state, agent of the patient, or to a health care practitioner or institution for administration or delivery of dialysis therapy to a patient with chronic kidney failure without being licensed as a pharmacy in this state if the following criteria have been met:

(1) The manufacturer or manufacturer's agent shipping to the patient is licensed as a wholesaler or other drug distributor;

(2) The dialysate is stored and delivered in the original, sealed, and labeled packaging from the manufacturing facility.

Records for all sales and distribution of dialysate must be retained and readily available for inspection for a period of two years from the date of the transaction.

S.D. Admin. R. 20:51:05:23

47 SDR 040, effective 10/12/2020

General Authority: SDCL 36-11-11(1)(10).

Law Implemented: SDCL 36-11-11(1)(10).