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