How are excipients "approved" for use in pharmaceutical products?

Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or finished new drug dosage forms. These mechanisms are: 1. Determination by FDA that the substance is "generally recognized as safe" (GRAS) pursuant to Title 21, U.S. Code of Federal Regulations, Parts 182, 184 or 186 (21 CFR 182, 184 & 186); 2.

Approval of a food additive petition as set forth in 21 CFR 171; or 3. The excipient is referenced in, and part of, an approved new drug application (NDA) for a particular function in that specific drug product. Excipients contained in over-the-counter (OTC) drug products subject to FDA monographs referenced in 21 CFR Parts 331-358 must comply with the requirements in 21 CFR 330.

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