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

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.

Cite as Ohio Admin. Code 4729-16-09

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