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U.S. Department of Health and Human Services

For Industry

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Data Standards

Stability Data Standard

Stability Data Standard is a Health Level Seven (HL7) standard to facilitate the processing and review of stability data.



Stability Data Standard Implementation Guide v1.9 (PDF)

Stability Data Validation Procedures (PDF)

Stability Data Standard Schema (Zip file)

Product Stability Data Pilot Project Completion Announcement (PDF)



Establishment of Health Level 7 (HL7) Standard for Submission of XML Stability Data – Norman Gregory (PDF)