Ohio Administrative Code
4729 - State Board of Pharmacy
Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products
Section 4729-12-10 - [Rescinded] Criteria to be considered in denying a petition for exemption or removing a drug product exemption

Universal Citation: OH Admin Code 4729-12-10

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 [Rescinded] Criteria to be considered in denying a petition for exemption or removing a drug product exemption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

(Effective: 8/1/2019
Five Year Review (FYR) Dates: 3/27/2019
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.44
Prior Effective Dates: 03/13/1995, 05/24/2015)
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.