Chapter 4729-31 Fluid Therapy Pharmacies

4729-31-01 Definitions.

As used in this chapter of the Administrative Code:

(A) "Compounded sterile product prescription" shall have the same meaning as in rule 4729-19-01 of the Administrative Code.

(B) "Fluid therapy pharmacy" means a pharmacy where the primary purpose is to compound and dispense parenteral compounded sterile product prescriptions. Such a pharmacy must comply with the minimum standards for compounding parenteral or sterile product prescriptions as defined in rule 4729-19-04 of the Administrative Code.

Replaces: Replaces 4729-31-01

Effective: 01/01/2009
R.C. 119.032 review dates: 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.01 , 4729.01
Prior Effective Dates: 3/1/1999

4729-31-02 Prescriptions for sterile products.

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.

(A) Oral orders, where permitted by law, issued by a prescriber for patients of a fluid therapy pharmacy may be transmitted to a pharmacist by a prescriber or a prescriber's agent. Such orders shall be recorded by the pharmacist noting the full name of the authorized personnel transmitting the order. The original signed prescriptions must remain with the patient's records at the prescriber's office or the institutional facility where it was issued.

(B) Drug orders for patients of a fluid therapy pharmacy transmitted to a pharmacist by the use of a facsimile machine shall only be valid if permitted by law and if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the patient's records including the positive identification of the prescriber and the prescriber's agent as well as identification of the origin of the facsimile. The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the drug order for three years from the date of the last transaction. The original signed drug order from which the facsimile is produced shall not be issued to the patient. The original signed drug order must remain with the patient's records at the prescriber's office or the institutional facility where it was issued. A facsimile of a drug order received by a pharmacist in any manner other than transmission directly from the prescriber or the prescriber's agent shall not be considered a valid prescription, except as a copy.

(C) 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.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.06 , 3719.07 , 4729.37
Prior Effective Dates: 3/1/1999

4729-31-03 Labeling.

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:

(A) The telephone number of the pharmacy, and the name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

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

(C) The full name of the prescriber;

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

(E) The date of dispensing;

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

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

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

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

(J) Beyond use date;

(K) Storage conditions.

Effective: 01/01/2011
R.C. 119.032 review dates: 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.64 , 3719.08
Prior Effective Dates: 3/1/99, 1/1/04, 1/1/09

4729-31-04 Recordkeeping.

In a fluid therapy pharmacy, the responsible pharmacist shall be responsible for maintaining the following records:

(A) A record of all drugs purchased, the quantity received, and the name, address, and wholesale or terminal distributor of dangerous drugs license number of the person from whom the drugs were purchased.

(B) All drug orders and records relating to the practice of pharmacy. Such drug orders and records may be retained by any process providing an exact duplicate of the original order. In addition, if an alternate recordkeeping system is utilized, these records may be stored on any storage medium that meets industry standards for quality and has stability for a period of at least three years. Records on an automated data processing system, or subsequent storage of such records, must be readily retrievable , within seventy-two hours.

(1) Records of drugs dispensed shall include, but are not limited to:

(a) The name, strength, and quantity of drugs dispensed;

(b) The date of dispensing;

(c) The name of the patient to whom, or for whose use, the drug was dispensed;

(d) Positive identification of all pharmacists involved in each function of the dispensing; and

(e) Disposal record of any unused drug(s).

(2) All other records relating to the practice of pharmacy other than dispensing shall include, but not limited to:

(a) The name of the inpatient to whom, or for whose benefit the activity was performed;

(b) The practice of pharmacy activity performed;

(c) The results of the activity, if applicable; and

(d) Positive identification of all pharmacists involved in each function of the activity.

(C) A record of all drugs compounded which shall include at least the following:

(1) Name of drug, strength, and dosage form;

(2) Quantity of drug(s) added to each container;

(3) Disposition of unused drug(s) and amount;

(4) Manufacturer's or distributor's control number;

(5) Manufacturer's or distributor's name, if a generic drug is used;

(6) Pharmacy control number, if prepared in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;

(7) Date of compounding;

(8) Manufacturer's or distributor's expiration date;

(9) The pharmacy's expiration date or beyond-use date;

(10) Positive identification of the registered pharmacist responsible for the compounding or repackaging of each drug product.

(D) All records must provide accountability and ensure that patients do not receive more drugs than intended by the prescriber. All records shall be readily retrievable and uniformly maintained in an unalterable and secure manner for at least three years from the date of the last dispensing.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.07 , 4729.37 , 4729.55
Prior Effective Dates: 3/1/1999