Ohio Admin. Code 4729-27-01 - [Rescinded] Peritoneal dialysis solutions

(A) For the purpose of Chapter 4729. of the Revised Code, the term "peritoneal dialysis solutions" shall mean the commercially available, unopened, sterile solutions whose only purpose is to be instilled into the peritoneal cavity during the medical procedure known as peritoneal dialysis.

(B) Each person, whether located within or outside this state, who sells peritoneal dialysis solutions in original packages labeled as required by applicable federal and state laws, rules, and regulations to persons residing in this state, shall obtain a limited category II terminal distributor of dangerous drugs license from the board of pharmacy pursuant to the provisions of sections 4729.54, 4729.55, and 4729.551 of the Revised Code. This requirement shall not apply to persons already licensed to purchase, possess, and sell unlimited category II or III dangerous drugs at retail.

(C) Peritoneal dialysis solutions may be sold at retail to patients only pursuant to an order from a person authorized to prescribe peritoneal dialysis solutions in the course of professional practice.

(D) Peritoneal dialysis solutions may be sold at retail and must be maintained in accordance with Chapters 3715. and 4729. of the Revised Code; rules 4729-9-04, 4729-9-05, 4729-9-11, 4729-9-12 and 4729-9-17 of the Administrative Code; and applicable federal laws and regulations.

(E) All retail sellers of peritoneal dialysis solutions shall maintain records of purchase of peritoneal dialysis solutions at wholesale and sale of peritoneal dialysis solutions at retail for three years at the licensed location, or an alternate site approved by the board, for inspection and copying by authorized board of pharmacy agents. The record of sale must include, but is not limited to, the order issued by the person authorized to prescribe peritoneal dialysis solutions in the course of professional practice.

(F) Before making an initial sale of peritoneal dialysis solutions to a patient, the retail seller must have an order issued by a person authorized to prescribe peritoneal dialysis solutions in the course of the professional practice. The order must include the full name and address of the patient, the name and address of the prescriber, and the complete and accurate identification of each such product to be provided to the patient.

Replaces: 4729-27-01. 4729-27-02; 4729-27-03, 4729-27-04, 4729-27-05

Notes

Ohio Admin. Code 4729-27-01

Effective: 9/1/2019
Five Year Review (FYR) Dates: 3/27/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55, 4729.551
Prior Effective Dates: 01/17/1997, 03/01/2017