Drug shortages and compounding
When FDA determines a drug is in national shortage, certain compounding restrictions are relaxed. When the shortage resolves, those exceptions end after any announced transition period.
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Who this applies to
FDA-approved drug products determined to be in shortage
Definitions
- Shortage
- A period when demand or projected demand within the U.S. exceeds supply, determined on a nationwide basis.
- Enforcement discretion
- FDA's decision not to take action for a defined period, not a change in the law.
Decision flow
- Is the approved drug on FDA's drug shortage list?
- If yes, compounding copies may be allowed under 503A/503B for the duration.
- When FDA declares the shortage resolved, copy restrictions return; FDA may provide a transition period.
- Local stock-outs do not equal a national shortage.
Examples
- • Tirzepatide injection was on the shortage list; after FDA resolved the shortage on 2024-12-19, 503A copies became restricted again.
- • Semaglutide injection shortage was resolved 2025-02-21.
Common mistakes / limitations
- ✗ A shortage determination does not approve a new drug.
- ✗ FDA's list is national, not local.
What can change this answer
Rules can change through new legislation, FDA final guidance, declaratory orders, court decisions, or updated bulk-drug-substance lists. Check the latest controlling sources and the update feed for this rule.
Controlling law and sources
- Declaratory Order: Resolution of Shortages of Semaglutide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages
- Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products
U.S. Food and Drug Administration · Declaratory order · Drug Shortages