Chapter 4729-13 Approved Laboratories

4729-13-01 Definitions.

As used in Chapter 4729-13 of the Administrative Code:

(A) "Controlled substance" has the same meaning as in section 4729.01 of the Revised Code.

(B) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.

(C) "D.E.A." means the federal drug enforcement administration.

(D) "Laboratory" means any establishment or place where dangerous drugs are possessed for scientific and clinical purposes and for purposes of instruction that has been approved by the state board of pharmacy.

(E) "Registration numbers" means the numbers assigned to each person registered under the federal drug abuse control laws, sections 4729.52 and/or 4729.54 of the Revised Code.

(F) "Responsible person" means the individual designated by the licensee as the person who will maintain supervision and control over the possession and custody of such dangerous drugs that may be acquired and utilized by the licensee.

Replaces: 4729-13-01

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

4729-13-02 Procedure for state board of pharmacy approval as a laboratory.

(A) A person, as defined in division (S) of section 4729.01 of the Revised Code, desiring to be approved by the state board of pharmacy as a laboratory shall file with the state board of pharmacy a completed application containing information relative to the qualifications for approval as set forth in rule 4729-13-03 of the Administrative Code.

(B) The state board of pharmacy shall issue a terminal distributor of dangerous drugs license to purchase, possess, and utilize dangerous drugs for scientific and clinical purposes and for purposes of instruction at the establishment or place described in the application to each person who has submitted an application and has paid the required license fee if the board determines that such applicant meets the requirements set forth in this chapter.

(C) All licenses issued pursuant to this rule shall be effective for a period of twelve months from the first day of January of each year. A license shall be renewed by the state board of pharmacy for a like period, annually, according to the provisions of this rule, and the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

(D) The fee required for issuance of the license shall be the same as that required in section 4729.54 of the Revised Code.

(E) A person desiring to renew the license shall submit a completed application for such renewal and pay the required fee on or before the thirty-first day of December each year.

(F) The state board of pharmacy, within thirty days after receipt of an application filed in the form and manner set forth in this rule for the issuance of a new or renewal license, shall notify the applicant whether or not such license will be issued or renewed. If the board determines that such license will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license will not be issued or renewed.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55
Prior Effective Dates: 4/1/1978, 7/1/1989, 7/1/1994, 3/1/1999, 1/1/2004

4729-13-03 Qualifications for a laboratory.

A laboratory to be approved by the state board of pharmacy to be entrusted with the custody and utilization of dangerous drugs and controlled substances for scientific and clinical purposes and for purposes of instruction must furnish satisfactory proof to the state board of pharmacy that:

(A) The applicant is qualified to conduct the business of an approved laboratory.

(B) The applicant will, on behalf of the applicant, the applicant's agents, and employees, submit to the jurisdiction of the state board of pharmacy and to the laws of this state for the purposes of the enforcement of Chapters 3719. and 4729. of the Revised Code.

(C) Adequate safeguards are assured to prevent the illegal acquisition, distribution, or utilization of dangerous drugs or their diversion into illicit channels.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.55
Prior Effective Dates: 4/1/1978, 7/1/1989, 7/1/1994, 3/1/1999

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

4729-13-05 Security controls for laboratories.

(A) Areas designated for the storage of dangerous drugs shall meet the security requirements in paragraph (B) of rule 4729-9-11 of the Administrative Code.

(B) Controlled substances shall be stored in a securely locked, substantially constructed cabinet.

(C) Etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. government class V security container.

(D) The responsible person shall notify the state board of pharmacy, law enforcement authorities, and the regional office of the drug enforcement administration in his region of the theft or significant loss of any dangerous drugs or controlled substances upon discovery of such loss or theft pursuant to rule 4729-9-15 of the Administrative Code.

R.C. 119.032 review dates: 04/03/2014 and 04/03/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.09 , 4729.51 , 4729.55
Prior Effective Dates: 4/1/1978, 7/1/1989, 7/1/1994, 3/1/1999

4729-13-06 Responsible person for approved laboratories.

(A) The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the business.

(B) The responsible person is responsible for maintaining adequate supervision and control over the dangerous drugs and controlled substances acquired, utilized, destroyed, or administered by the approved laboratory and maintaining all records required by this chapter and federal law to be kept at the establishment or place described in the license.

(C) If there is a change in the responsible person, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible person.

(1) This notice to the board of pharmacy shall be made by completing, signing, and returning the form supplied by the board by regular mail or by verified facsimile transmission.

(2) A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible person. The new responsible person shall be responsible for this inventory.

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: 3719.09 , 4729.55 , 4729.57
Prior Effective Dates: 4/1/1978, 7/1/1989, 7/1/1994, 1/1/2004