FDA Drug Shortage List
The FDA drug shortage list is the agency's official register of products in shortage, and a listing carries legal consequences well beyond information, notably for what compounders may lawfully make.
FDA maintains a drug shortages database supported by statutory obligations that require manufacturers to notify the agency of interruptions in supply. A listing records that demand exceeds available supply nationally for a product, notes the reason where it is known, and is resolved when FDA determines that supply meets or exceeds demand. That is a judgement about the market as a whole, not about whether any particular pharmacy has stock on the shelf.
The legal weight sits in the compounding provisions. A compounder may not make a drug that is essentially a copy of a commercially available product, but the prohibition lifts while the drug is on the shortage list, and outsourcing facilities may use bulk substances on that basis. The GLP-1 episode showed the mechanism working end to end: large-scale compounding of semaglutide and tirzepatide during listing, then wind-down periods once FDA declared the shortages resolved, with litigation along the way. Which products are listed today is a live question for the database itself.
The list is therefore better read as a legal instrument than as a supply bulletin. A resolved status does not mean every pharmacy is stocked and it does not mean patients transitioned smoothly; it means the statutory carve-out closed. Independent lists, such as the one maintained by ASHP, apply different criteria and routinely disagree with FDA on both listing and resolution.
The misuse is retrospective. A clinic that compounded lawfully during a shortage may keep implying the same footing afterwards, and grey-market sellers invoke shortage as a general justification for products that were never in shortage, or were never approved and so could not be. Shortage status attaches to a specific approved product, not to a molecule in the abstract.