4729-16-05 Drugs compounded in a fluid therapy pharmacy.

(A) For all non-sterile compounded prescriptions, the fluid therapy pharmacy shall comply with the United States pharmacopeia chapter <795> (01/01/2014).

(B) For all sterile compounded prescriptions, the fluid therapy pharmacy shall comply with the United States pharmacopeia chapter <797> (08/01/2014).

(C) When prepared in a fluid therapy pharmacy, drugs shall be dispensed by a pharmacist pursuant to an original patient-specific order issued by a prescriber.

(D) All prescriptions shall be issued pursuant to rule 4729-5-30 of the Administrative Code.

(E) All prescriptions shall be processed pursuant to rule 4729-5-21 of the Administrative Code.

(F) All drug orders for patients of a fluid therapy pharmacy shall include, but are not limited to, at least the following:

(1) Name and address of the patient;

(2) Name, strength, and dosage form of the drug;

(3) Directions for use, including route of administration;

(4) Date prescribed;

(5) Prescriber's positive identification;

(6) Length of therapy or total quantity to be dispensed.

(G) When prepared in a fluid therapy pharmacy, no compounded parenteral product prescription may be dispensed unless a label is affixed to the container in which such drug is dispensed and such label includes:

(1) The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(2) The telephone number of the pharmacy;

(3) The full name of the patient for whom the drug is prescribed;

(4) The full name of the prescriber;

(5) Directions for use of the drug which must include route of administration;

(6) The date of dispensing;

(7) Any cautions which may be required by federal or state law;

(8) The name and amount of the drug(s) added;

(9) The name and volume of the parenteral solution;

(10) The quantity of drug dispensed, if appropriate;

(11) Beyond use date;

(12) Storage conditions.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.06, 3719.07, 4729.37