Are nasal sprays drug-device combination products?
Nasal sprays are drug-device combination products, as defined in FDA 21 CFR 3.2(e): “A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity”. Furthermore, the FDA identifies and describes nine different types of combination product – nasal sprays fall under type 2: “Prefilled Drug Delivery Device/ System”, where “drug is filled into or otherwise combined with the device AND the sole purpose of the device is to deliver drug”.
Since nasal sprays are considered drug/device combination products, both formulation, development, and device selection are critical to the effective performance of the product. At Renaissance, we have a full research and development team with years of experience in nasal spray formulation development and device selection. Contact us to learn more about our nasal spray research and development capabilities.