4729-13-04 Record keeping.

Each laboratory approved by the state board of pharmacy pursuant to this chapter shall keep records pursuant to paragraph (B) of rule 4729-9-14 of the Administrative Code, and as follows:

(A) Each approved laboratory conducting chemical analysis with dangerous drugs or controlled substances shall maintain records with the following information for each dangerous drug or controlled substance:

(1) The name.

(2) The form or forms received or manufactured by the registrant (e.g., powder, granulation, tablet, capsule, or solution) and the concentration in such form (e.g., "C.P.," "U.S.P.," "N.F.," ten-milligram tablet, or ten-milligram concentration per milliliter).

(3) The total number of the forms received or manufactured (e.g., one hundred tablets, thirty one-milliliter vials), including the date and quantity of each receipt or manufacture, and the name, address, and registration number, if any, of the person from whom received.

(4) The quantity utilized in any manner by the laboratory including the date and manner of utilization, and the name, address, and registration numbers, if any, of each person to whom provided for utilization.

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

(6) Destruction of dangerous drugs, other than controlled substances, shall be conducted in accordance with paragraph (C) of rule 4729-9-22 of the Administrative Code.

(B) Each approved laboratory conducting research with dangerous drugs or controlled substances shall maintain records with the following information for each dangerous drug or controlled substance:

(1) The name.

(2) Each finished form (e.g., ten-milligram tablet or ten-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., one-hundred-tablet bottle or five-milliliter vial).

(3) The number of commercial containers of each such finished form received from other persons including the date of and the number of containers in each receipt and the name, address, and registration numbers of the persons from whom the containers were received.

(4) The number of units or volume of such finished dosage form or commercial containers provided. The date and name and address of the person to whom it was provided. The date and name and address of the person utilizing or administering the drug and the quantity utilized on behalf of the researcher.

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

(6) Destruction of dangerous drugs, other than controlled substances, shall be conducted in accordance with paragraph (C) of rule 4729-9-22 of the Administrative Code.

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: 3719.07 , 4729.55 , 4729.57
Prior Effective Dates: 4/1/1978, 7/1/1989, 7/1/1994