4729-16-02 Sterile compounded drugs provided by an outsourcing facility.

 

 

 

4729-16-02                  STERILE  COMPOUNDED  DRUGS  PROVIDED  BY  AN OUTSOURCING FACILITY.

 

 

 

(A)An entity may provide, without a patient specific prescription, a non-patient specific sterile compounded drug preparation for human use only, if the following conditions apply:

 

(1)The entity is registered with the United States Food and Drug Administration as an outsourcing facility pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013); and

 

(2)The entity is licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification pursuant to section 4729.52 of the Revised Code. The entity must include a licensed pharmacist as the responsible person on the license.

 

(B)This rule does not apply to pharmacies that compound drugs for direct administration by a prescriber pursuant to rule 4729-9-25 of the Administrative Code.

 

(C)The outsourcing facility shall comply with all labeling and  recordkeeping requirements pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (11/27/2013).

 

(D)If an entity licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification pursuant to division (A) of this rule dispenses patient specific drugs, it must also register as a terminal distributor of dangerous drugs. All laws and rules applicable to the terminal distributor license shall apply to dispensing of patient specific drugs.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4729-16-02                                                                                                                            2

Effective:                                                             10/24/2014

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, 4729.51, 4729.52, 4729.54, 4729.55, 4729.56