4729-9-14 Records of controlled substances.

(A) Each prescriber or terminal distributor of dangerous drugs shall keep a record of all controlled substances received, administered, dispensed, sold, destroyed, or used. The acts of prescribing, administering, dispensing, and destroying of a controlled substance 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.

(1) Records of receipt shall contain a description of all controlled substances received, the kind and quantity of controlled substances received, the name and address of the persons from whom received, and the date of receipt.

(2) Records of administering, dispensing, or using controlled substances shall contain a description of the kind and quantity of the controlled substance administered, dispensed, 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 controlled substance was administered, dispensed, or used.

(3) Records of drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the name and address requirements of paragraph (A)(2) of this rule.

(4) Destruction of controlled substances shall be conducted in accordance with rule 4729-9-06 of the Administrative Code.

(B) Each prescriber or terminal distributor of dangerous drugs shall maintain an inventory of all controlled substances as follows:

(1) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken.

(a) The name of the substance.

(b) The total quantity of the substance.

(i) Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter).

(ii) The number of units or volume of each finished form in each commercial container (e.g., one-hundred-tablet bottle or ten-milliliter vial).

(iii) The number of commercial containers of each such finished form (e.g., three one-hundred-tablet bottles or ten one-milliliter vials).

(c) If the substance is listed in schedule I or II, the prescriber or terminal distributor of dangerous drugs shall make an exact count or measure of the contents.

(d) If the substance is listed in schedule III, IV, or V, the prescriber or terminal distributor of dangerous drugs may make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which an exact count of the contents must be made.

(2) A separate inventory shall be made for each place or establishment where controlled substances are in the possession or under the control of the prescriber or terminal distributor. Each inventory for each place or establishment shall be kept at the place or establishment.

(3) An inventory of all stocks of controlled substances on hand on the date the prescriber or terminal distributor first engages in the administering, dispensing, or use of controlled substances. In the event the prescriber or terminal distributor of dangerous drugs commences business with no controlled substances on hand, this fact shall be recorded as the initial inventory.

(4) Each prescriber or terminal distributor of dangerous drugs shall take a new inventory of all stocks of controlled substances on hand every two years following the date on which the initial inventory is taken.

(5) When a substance is added to the schedule of controlled substances by the federal drug enforcement administration or the state board of pharmacy, each prescriber or terminal distributor of dangerous drugs shall take an inventory of all stock of such substance on hand at that time.

(C) All records of receipt, distribution, administering, dispensing, inventory, destruction, or using controlled substances shall be kept for a period of three years at the place where the controlled substances are located. 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 controlled substances. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor of dangerous drugs.

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
Rule Amplifies: 3719.07
Prior Effective Dates: 4/1/1978, 1/1/1981, 7/1/1989, 3/1/1999, 3/31/2000, 1/1/2004, 10/19/2007