5i Drugs
Definition
The term ‘5i drugs’ refers to drugs administered by five specific routes: inhaled, infused, instilled, implanted, or injectable. This terminology is widely used in the 340B program as a practical shorthand, though it is not formally defined in statute. The concept is relevant to the Covered Outpatient Drugs Final Rule and how certain drug types are classified.
5i drugs are particularly relevant in hospital outpatient settings where these administration routes are common. Ensuring that 5i drugs purchased under 340B are being used for eligible outpatient patients—not inpatients—is an important compliance consideration, especially in mixed-use settings such as infusion centers, emergency departments, and surgery centers.
For covered entities operating mixed-use settings, tracking whether 5i drugs are being administered to inpatient or outpatient patients is a key data integrity requirement. Purchasing 340B drugs for inpatient use is not permitted and is a common source of compliance findings.
Frequently Asked Questions
Why 5i Drugs Matters
5i drugs are frequently involved in mixed-use setting compliance issues. Covered entities that operate infusion centers, surgery centers, or emergency departments must have robust tracking systems to ensure 5i drugs purchased at 340B prices are only being used for eligible outpatient patients.
How Virtue 340B Uses It
Virtue 340B evaluates 5i drug compliance as part of our audit services, particularly for covered entities with mixed-use settings where the risk of inpatient/outpatient misclassification is elevated.