Q&A library · 340b-program
How do covered entities document 340B eligibility for limited-distribution specialty drugs?
Covered entities must create an auditable record linking the patient encounter, prescriber relationship, prescription, dispensing activity, and 340B accumulation or replenishment logic. When an outside specialty pharmacy dispenses, they also need proof of data transmission, pre-dispense eligibility validation, channel control, and prevention of diversion or duplicate discounts.