Each prescriber or terminal distributor of dangerous drugs shall keep a record of all dangerous drugs received, administered, dispensed, personally furnished, distributed, sold, destroyed, or used. The acts of prescribing, administering, dispensing, and destroying of a dangerous drug must be documented with the positive identification of the responsible individual pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code. These records may be kept electronically if the method is approved by the state board of pharmacy and the records are backed-up each business day.
(A) Records of receipt shall contain a description of all dangerous drugs received, the kind and quantity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.
(B) Records of administering, dispensing, personally furnishing, or using dangerous drugs shall contain a description of the kind and quantity of the dangerous drugs administered, dispensed, sold, or used, the date, the name and address of the person to whom or for whose use, or the owner and identification of the animal for which, the dangerous drug was administered, dispensed, or used.
(C) Records of dangerous drug destructions, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date destroyed, the method of destruction, the positive identification of the prescriber or responsible person that performed the destruction, and if used the positive identification of the person that witnessed the destruction.
(D) Records of dangerous drugs, other than controlled substances, administered, personally furnished, dispensed, or used which become a permanent part of the patient's medical record shall be deemed to meet the requirements of paragraph (B) of this rule.
(E) All records of receipt, distribution, personally furnishing, administering, dispensing, selling, destroying, or using dangerous drugs shall be kept for a period of three years at the place where the dangerous drugs are located and upon request provided to a state board of pharmacy officer, agent, and/or inspector within three working days, excluding weekends and holidays. Any terminal distributor of dangerous drugs intending to maintain such records at a location other than this place must first send a written request to the state board of pharmacy. The request shall contain the terminal distributor of dangerous drug name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy will send written notification to the terminal distributor of dangerous drugs documenting the approval or denial of the request. A copy of the board's approval shall be maintained with the other records of dangerous drugs. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor of dangerous drugs.
Five Year Review (FYR) Dates: 02/21/2017 and 05/10/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.37, 4729.541
Prior Effective Dates: 7/1/1994, 3/1/1999, 3/31/2000, 1/1/2004, 10/19/2007, 01/01/2009