DSCSA Suspect Lot: How Many Packages to Verify
How many packages of a suspect lot a dispenser must verify under the DSCSA.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Packages of the suspect product in your possession
- 41
- Small business dispenser?
- Not a small business dispenser
Result: Verify the product identifier of at least 5 of 41 packages.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Packages of the suspect product in your possession
- Small business dispenser?
How this is calculated
Citation
21 U.S.C. 360eee-1(d)(4)(A)(ii)(II): verify the product identifier of at least 3 packages or 10 percent of the suspect product, whichever is greater, or all packages if fewer than 3. FDA letter of August 6, 2026: small business dispensers exempted until November 27, 2027. Read the sources: 21 U.S.C. 360eee-1 ↗, FDA letter, August 6, 2026 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.