U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA Data Standards Advisory Board
  4. Stability Data Standard
  1. FDA Data Standards Advisory Board

Stability Data Standard

The Stability data submission requirements have now been subsumed by FDA’s new Pharmaceutical Quality/Chemistry, Manufacturing & Controls (PQ/CMC) project.  PQ/CMC project scope covers standardization and structuring of eCTD Module 3 content and therefore FDA has consolidated Stability data standards & supporting terminology with the PQ/CMC effort. You can learn more about the PQ/CMC Project on FDA Data Standards Advisory PQ/CMC page.

Since Stability data exchange information is a Health Level 7 (HL7) and ANSI approved message, FDA has formally withdrawn the  HL7 V3 eStability message specification from the HL7 Standards Organization and is in the process of withdrawing the HL7 V3 Stability Data Standards Implementation Guide.

If you have questions concerning this, please contact PQ-CMC@fda.hhs.gov.

Back to Top