Guide to Developing Instruction for Use (IFU)

Guide to Instructions for Use (IFU) is a form of prescription drug labeling that provides patients with detailed, action-oriented, step-by-step instructions for using their prescription drug products. The IFU is generally created for drug products that have complicated or detailed patient-use instructions and is reviewed and approved by the FDA under an NDA, BLA, or ANDA. It is generally provided to patients when the drug product is dispensed.

What should an Instruction for Use Contain?

The IFU should contain written instructions on preparation, administration, handling, storage, and disposal, as well as visuals that complement the written instructions. The goal of the IFU is to help guide patient understanding of how to use their prescription drug products. To help industry develop consistent content and format of IFU documents, the FDA published the “Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products— Content and Format” in July 2019.

The guidance provides recommendations to ensure patients receive clear, concise information about prescription products that is easily understood. It applies to prescription drug products, including human prescription drug and biological products but is not intended for devices regulated under a BLA or labeling for standalone medical devices.

Applicants should submit a word copy of the IFU that accompanies the Prescribing Information for review and approval by the FDA. They should include true representations of both the content and format of the IFU, including page layout, graphic design, and color. The FDA will review and provide comments in the word version of the IFU.

Typically, information from the DOSAGE AND ADMINISTRATION, HOW SUPPLIED/STORAGE AND HANDLING, and PATIENT COUNSELING INFORMATION sections of the Prescribing Information are included in the IFU. The IFU may also contain additional details that are important for the patient’s safe and effective use of the drug product.

Clear and Easy to Understand Instruction for use

To ensure the IFU is clear and easy to understand, the guidance recommends that headings clearly identify the focus of each topic, subheadings group related tasks that accomplish a single objective, and the order of headings present the information in a specific order. The title “INSTRUCTIONS FOR USE” should appear centered prominently at the top of the first page of the IFU in bold uppercase letters.

The product title should include the proprietary name (if any), nonproprietary name, dosage form, and route of administration. It should be centered and presented in bold letters. If there is a proprietary name, it should include the pronunciation spelling after the proprietary name. If there is no proprietary name, the pronunciation spelling of the chemical portion of the nonproprietary name should follow the nonproprietary name.

The purpose statement should appear below the product title and inform the patient about the IFU contents – why it was created. The visual of the drug product should clearly identify and label each part of the drug product, including device components, and the purpose or use of the components, where applicable. The important information for patients should include specific, critical actions to prepare, administer, store, or dispose of the drug product and is generally intended to prevent or reduce potentially dangerous consequences that might occur if a specific action is not followed.

The IFU is an essential part of prescription drug labeling that provides patients with clear, concise instructions on how to use their prescription drug products safely and effectively. The guidance provided by the FDA ensures that the content and format of the IFU documents are consistent and patient-friendly. Patients should always read and follow the instructions in the IFU carefully to ensure they use their prescription drug products correctly.


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