What is the Origin of FDA Inactive Ingredient Database?

This resource stems directly from the U.S. Food and Drug Administration's mandate to regulate drug safety and efficacy, specifically addressing the composition of marketed products. The term 'Inactive Ingredient' distinguishes these components from the active pharmaceutical ingredient, even though they are essential for drug performance. The database consolidates historical approval data for ease of regulatory review.

What is the Mechanism of FDA Inactive Ingredient Database?

The IID operates as a repository allowing researchers to query approved uses of specific excipients, thereby facilitating the selection of ingredients with established safety records for novel formulations, such as sustained-release hormone implants or transdermal patches. When a new formulation utilizes an excipient already present in an approved product for the same route, the safety assessment pathway is often streamlined. This mechanism reduces redundant testing and accelerates the pathway for delivering new treatments to patients.

FDA Inactive Ingredient Database ∞ Area

FDA Inactive Ingredient Database

Meaning

The FDA Inactive Ingredient Database (IID) is a comprehensive public resource maintained by the U.S. Food and Drug Administration listing excipients that have been included in approved drug products, categorized by their route of administration and dosage form. Clinically, this database serves as a critical reference point for formulators designing new hormonal delivery systems, confirming the historical safety profile of proposed inactive components. It aids in rapid assessment during the Investigational New Drug (IND) application process.