Which additional labeling requirement is specific to outpatient sterile products?

In the context of outpatient sterile products, the requirement for providing directions for use on the label is essential. This information guides the patient on how to properly administer the sterile product, ensuring safety and effectiveness. Since outpatient sterile products are often dispensed for home use, clear instructions become a critical component for patient compliance and understanding. Having accurate directions directly addresses how the medication should be utilized, which is particularly important in outpatient scenarios where the responsibility for administration lies with the patient or their caregiver.

The other labeling requirements, while also important, do not specifically address the unique needs of outpatient sterile products. For instance, healthcare entity information is more relevant to institutional settings; the amount of drug added may not provide necessary information for the patient’s understanding of their treatment; and while prescriber name and address are important pieces of information, they do not directly assist the patient in using the product effectively at home. Thus, directions for use stand out as the most critical additional labeling requirement specific to outpatient settings.