Dual-Use Labeling

When manufacturers market a substance as an active pharmaceutical ingredient (API), current good manufacturing practices (CGMPs) apply and the manufacturing location must be registered with the US Food and Drug Administration (FDA) as a drug-manufacturing establishment. Although the United States Pharmacopeia (USP) designation normally is used for APIs and the National Formulary (NF) designation is generally used for excipients, there are exceptions. When a substance is labeled as USP or USP-NF without further clarification, one could assume that the substance may be used either as an API or an excipient, that the substance was manufactured according to CGMPs for APIs, and that the manufacturing facility is registered with FDA. If the product is presented for use as an excipient only, then registration is not required. By having clear documentation indicating intended use for their products, these companies avoided having to defend their decision not to register the plants.