4729-16-09 Terminal distributor licenses for compounding drugs and ordering compounded drugs.

(A) Except as provided in paragraph (B) of this rule, a licensed wholesale distributor or terminal distributor of dangerous drugs is prohibited from selling, shipping, mailing, or delivering dangerous drugs that are compounded or used for the purpose of compounding to a location licensed in Ohio unless the location is licensed as a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code.

(B) Beginning April 1, 2015, a licensed wholesale distributor or terminal distributor of dangerous drugs is prohibited from selling, shipping, mailing, or delivering dangerous drugs that are compounded or used for the purpose of compounding to a business entity described in division (B)(1)(j) or (B)(1)(k) of section 4729.51 of the Revised Code unless that business entity is licensed as a terminal distributor of dangerous.

(C) Beginning April 1, 2015, a business entity described in division (B)(1)(j) or (B)(1)(k) of section 4729.51 of the Revised Code shall hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, and distribute dangerous drugs that are compounded or used for the purpose of compounding.

Effective: 5/1/2015
Five Year Review (FYR) Dates: 05/01/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.541, 4729.55, 4729.54 , 4729-52, 4729.53