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Rule 4729:9-3-08 | Criteria to be considered in denying a petition for exception or removing a drug product exception.

 

(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 United States 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 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.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.44
Five Year Review Date: 8/1/2024
Prior Effective Dates: 3/13/1995, 5/24/2015