Ohio Admin. Code 4729:5-17-05 - Dialysis solutions - general provisions
(A) Each person , whether located within or
outside this state , who sells peritoneal dialysis solutions in this state shall
obtain a limited category II terminal distributor of dangerous drugs license.
The requirements of this paragraph do not apply to persons currently licensed
to purchase, possess, and sell dangerous drugs at retail in accordnce with
divison 4729:5 of the Administrative Code.
(B)All areas where dialysis solution is
stored shall be dry, well-lit, well-ventilated, and maintained in a clean and
orderly condition. Storage areas shall be maintained at temperatures and
conditions which will ensure the integrity of the dialysis solution prior to
use as stipulated by the USP/NF and/or the manufacturer's or distributor's
labeling.
(C) Dialysis solutions
shall be secured in a tamper-evident manner to deter and detect unauthorized
access.
(D) All retail sellers of
peritoneal dialysis solutions shall maintain records of purchase of dialysis
solutions at wholesale and sale of dialysis solutions at retail for three years
at the licensed location. All records shall be readily retrievable .
(1) A terminal distributor intending to
maintain records at a location other than the location licensed by the state
board of pharmacy must notify the board in a manner determined by the
board .
(2) Any such alternate
location shall be secured and accessible only to authorized representatives or
contractors of the terminal distributor of dangerous drugs .
(E) Prior to making an initial sale of
dialysis solutions to a patient, a terminal distributor of dangerous drugs must
have an order issued by a prescriber .
(1) The
order must include the full name and address of the patient, the signature of
the prescriber , the manually printed, typewritten, electronically generated or
preprinted full name and address of the prescriber , the telephone number where
the prescriber can be personally contacted during normal business hours, the
date of issuance and the complete and accurate identification of each such
product to be provided to the patient.
(2) The prescriber 's order may be transmitted
electronically to the retail seller.
(3) All orders issued in accordance with this
paragraph are valid for a period of one year from the date of
issuance.
(F) A terminal
distributor of dangerous drugs shall report the theft or significant loss of
dialysis solution pursuant to rule
4729:5-3-02 of the
Administrative Code.
Replaces: 4729-27-01
Notes
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
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