4729-5-17 Labeling by prescribers who personally furnish dangerous drugs to their patients.

 

 

 

4729-5-17                    Labeling  by  prescribers  who  personally  furnish  dangerous drugs to their patients.

 

 

 

(A)   Whenever a prescriber personally furnishes a dangerous drug, other than a sample drug pursuant to section 3719.81 of the Revised Code, the prescriber shall affix to the container a label showing:

 

(1)  The name and address of the prescriber.

 

(2)    The name of the patient for whom the drug is intended. If the patient is an animal, the name of the owner and identification of the animal.

 

(3)   Name and strength of the dangerous drug.

 

(4)   Directions for use.

 

(5)   Date furnished.

 

(B)    Whenever a prescriber personally furnishes a dangerous drug, labeled as a sample pursuant to section 3719.81 of the Revised Code and where the directions for use are different from the directions on or in the sample container, the prescriber shall also provide, in written format, the following:

 

(1)  Name of the prescriber.

 

(2)    Name of the patient. If the patient is an animal, the name of the owner and identification of the animal.

 

(3)   Directions for use.

 

(C)      For controlled substances, personally furnishing quantities are limited to a seventy-two hour supply and in any thirty day period the personally furnishing quantities supplied to all patients shall not exceed two thousand five  hundred dosage units pursuant to section 4729.291 of the Revised Code.

 

(D)None of the following shall be counted in determining whether the amounts specified in division (C) of this rule have been exceeded:

 

(1)Methadone provided to patients for the purpose of treating drug addiction, if the prescriber meets the conditions specified in 21 C.F.R. 1306.07 (6/23/2005);

 

(2)Buprenorphine provided to patients for the purpose of treating drug addiction, if the prescriber is exempt from separate registration with the United States

 

 

drug enforcement administration pursuant to 21 C.F.R. 1301.28 (5/22/2008);

(3) Controlled substances provided to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.

(E)Division (C) of this rule does not apply to a prescriber who is a veterinarian.

Effective:	08/22/2014
R.C. 119.032 review dates:	05/22/2019
CERTIFIED ELECTRONICALLY
Certification
08/12/2014
Date
Promulgated Under:	119.03
Statutory Authority:	3715.69 , 3719.28 , 4729.26
Rule Amplifies:	3715.64 , 3719.06 , 3719.08 , 3719.81 , 4729.29 ,
	4729.51
Prior Effective Dates:	06/01/1999, 03/31/2000, 05/22/2014