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 preparations , 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 ( 5/28/2015);

(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; and

(B) This rule does not apply to pharmacies that compound drugs for direct administration by a prescriber pursuant to rule 4729-16-07 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 ( 5/28/2015).

(D) If an entity licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification pursuant to paragraph (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.

(E) The entity is licensed as a wholesale distributor of dangerous drugs with an outsourcing facility classification shall comply with all of the following:

All applicable federal, state, and local laws and regulations, including but not limited, to the following:

(1) Chapter 4729-9 of the Administrative Code;

(2) Section 503B of the Federal Food, Drug, and Cosmetic Act (5/28/2015); and

(3) Current good manufacturing practices pursuant to Section 501 of the Federal Food, Drug and Cosmetic Act (5/28/2015).

Effective: 1/15/2016
Five Year Review (FYR) Dates: 10/24/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.01, 4729.51, 4729.52, 4729.54, 4729.55, 4729.56
Prior Effective Dates: 10/24/2014