4729-16-01 Definitions.

 

 

 

4729-16-01                  DEFINITIONS.

 

 

 

(A)As used in this section of the Administrative Code:

 

(1)"Outsourcing facility" means a facility at one geographic location or address that is engaged in anticipatory compounding of sterile drugs and complies with the United States Food and Drug Administration section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

 

(2) "Sterile" means a dosage form free of living microorganisms (aseptic).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4729-16-01         Effective:	10/24/2014	2
Five Year Review (FYR) Dates:	10/24/2019
CERTIFIED ELECTRONICALLY
Certification
10/14/2014
Date
Promulgated Under:	119.03
Statutory Authority:	4729.26, 3719.28
Rule Amplifies:	4729.01