4729-12-10 Criteria to be considered in denying a petition for exemption or removing a drug product exemption.

(A) The board shall consider the following factors in determining whether a particular over-the-counter (OTC) drug product containing the schedule V controlled substance ephedrine is manufactured and distributed for legitimate use in a manner consistent with the pertinent OTC tentative or final monograph issued by the federal food and drug administration and in a manner that reduces the likelihood of inappropriate use and/or abuse:

(1) The package size and the manner of packaging;

(2) distribution, advertising, and promotion of the product;

(3) labeling and the name of the product;

(4) the potential, duration, scope, and significance of inappropriate use and/or abuse;

(5) other facts as may be relevant to and consistent with the public health and safety.

(B) The board shall remove a drug product exception for a particular drug product if it determines that the drug product is not manufactured and distributed for legitimate use and in a manner that reduces the likelihood of abuse.

R.C. 119.032 review dates: 02/01/2005 and 12/31/2009

Promulgated Under: 119.03

Statutory Authority: 3719.28, 4729.66

Rule Amplifies: 3719.44

Prior Effective Dates: None