The IFU provides detailed, action-oriented, step-by-step written and visual instructions for the patient on how to use the drug including instructions on preparation, administration, handling, storage, and disposal. The IFU is developed by applicants for patients (or their caregivers) who use prescription drugs that have complicated or detailed patient-use instructions. The Instructions for Use (IFU) is patient labeling that can be part of FDA-approved prescription drug labeling for a biologics license application (BLA), a new drug application (NDA), or an abbreviated new drug application (ANDA). Drug labeling resources for healthcare professionals, patients, and caregivers, visit Frequently Asked Questions about Labeling for Prescription Medicines.
Other prescription drug labeling resources for industry such as those for the Prescribing Information, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs.For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs see video.
