The moment a shortage becomes real for a patient is at a pharmacy counter, when someone says the medication is on back order and cannot say when it will return. There were 227 active drug shortages tracked in the second quarter of 2026, a third consecutive quarterly increase.
Almost nothing about that moment suggests a connection to a Federal Register notice about establishment registration. But the link is direct, and it runs through a specific question: whether the FDA knows which factories, anywhere in the world, are making the ingredients in a given prescription.