Outdated and unsaleable medications account for an estimated 1.5% of the nearly $700 billion annual U.S. pharmacy market, or approximately $10 billion in potentially recoverable revenue for pharmacies, according to a Sept. 21 Health Affairs Forefront commentary.
Here are five things to know:
- Federal law does not clearly require manufacturers to accept expired, unused or unsaleable medications from pharmacies, the authors wrote. Outside of certain Drug Enforcement Administration requirements for controlled substances, pharmacies rely largely on manufacturer return policies.
- Virginia and Mississippi adopted expanded drug return requirements in 2025. The laws require manufacturers to accept returns of certain outdated medications with full credit or replacement for up to six months after the product’s labeled expiration date.
- The laws differ in scope. Virginia’s requirements cover therapeutically equivalent drugs listed in the FDA’s Orange Book. Mississippi’s law covers brand and generic drugs but exempts biological products, infused or intravenously injected medications and drugs inhaled during surgery.
- Both states established penalties for noncompliance. Virginia tied compliance to manufacturers’ ability to engage in therapeutic substitution, while Mississippi adopted a similar structure involving state drug assistance programs.
- The authors called for additional states to act in 2027 while aligning legislative language to avoid a 50-state patchwork of drug return requirements.
