What is the FDA drug shortage list, and why does it matter for compounding?

What the law and FDA say

21 U.S.C. 356e directs FDA to maintain an up-to-date public list of drugs it has determined to be in shortage. Each entry is to include the drug name and national drug code, the manufacturers, the reason for the shortage from a fixed set of categories, and the estimated duration. The statute has exceptions for trade secrets and for disclosure that could cause hoarding.

FDA's drug shortage FAQ says a shortage exists when demand or projected demand for the drug within the U.S. exceeds its supply, and that a status becomes resolved when FDA determines supply no longer falls short.

Why it matters for compounding

As our answer on 503B compounding explains, an outsourcing facility may compound from a bulk substance that is not on the 503B list only if the finished drug is on FDA's shortage list at the time of compounding, distribution and dispensing. Whether a listing is current or resolved can therefore change what is allowed. Check the list for the drug and date in question.

What it does not tell you

• The list covers drugs FDA has determined to be in shortage, not every supply problem a patient or pharmacy experiences.
• Most shortage information reaches FDA from manufacturers, through a portal FDA describes on its shortages page.
• A listing does not make a compounded product FDA-approved.