Excipients for Over-the-Counter Drugs

Therefore, excipients that comprise the bulk of OTC drug products must only be deemed safe and suitable by the drug manufacturer prior to use.c 

The controversy with the Hemorrhoidal Panel was mainly the result of the fine line between active and inactive ingredients in some therapeutic classes. Ingredients that were generally used as inactive ingredients in most drugs could potentially be considered as the active ingredient in products indicated for the relief of such minor 

6 Time-release technology from the time of the OTC review (1970s) was prone to dose-dumping. 

Significant improvements have been made in time-release formulation in the last several decades. fThe Bureau of Drugs was the predecessor of the Center for Drug Evaluation and Research. 

The ingredient is listed in an official compendium [e.g., USP/National Formulary (NF)] as a pharmaceutical aid or performed certain physical or technical functions in the final formulations (as will be set forth below). 

The inactive ingredient is used at a level no higher than reasonably required to achieve its physical or technical function. For example, an antimicrobial excipient ingredient could only be used at a level consistent with preservation of the finished product (not at therapeutic levels), and a sunscreen ingredient could only be used at levels that protected the product from breaking down if the top of the jar was left open, not for protecting the user. 

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