Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.
The purpose of a Time and Extent Application (TEA) is to request that applicable conditions be considered for inclusion in the OTC monograph system (21 CFR 330.14). Submission of a TEA is only the first step of a two-step process to demonstrate eligibility of the condition for the OTC monograph review process.
