On July 1, 2019, FDA issued draft guidance on the content and format of Instructions for Use (IFU) documents that accompany prescription drugs, biological products, and drug-device or biologic-device combination products. The draft guidance seeks to ensure that patients can easily understand and safely use drug products that have complicated or detailed patient-use instructions.

The content of an IFU should be consistent with the FDA-approved prescribing information, use active voice and simple vocabulary, and utilize headings that clearly identify each topic. More specifically, the draft guidance recommends the following sections in each IFU and details the proper content for each section:

  • IFU Title
  • Product Title
  • Purpose Statement
  • Visual of Drug Product
  • Important Information for Patients
  • Preparation Instructions
  • Administration Instructions
  • Storage Instructions
  • Disposal Instructions
  • Additional Information

FDA also recommends that the format of an IFU aid patient understanding of complex prescription information. For font, this includes using a sans-serif font such as Verdana or Arial, and using a size no smaller than 10 pts. Bold, italics, underlined, and uppercased text should be used sparingly in order to highlight critical concepts. As to page layout, FDA recommends the sequential numbering of each step, with clear instructions when to repeat or skip steps. Accompanying visual instructions are also helpful for patient comprehension. FDA further recommends that the IFU effectively use white space to signal separate concepts, and use only black type on a white background for text in order to maximize legibility.