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# Data and Documentation Guidance
- URL: https://www.fdaweb.com/data-and-documentation-guidance/
- Published: 2018-02-28T12:00:00.000Z
- Updated: 2026-09-14T23:26:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140872

FDA has issued a draft guidance, *Standardization of Data and Documentation Practices for Product Tracing*, elaborating standards for the interoperable exchange of transaction information, transaction history, and transaction statements required by the Drug Supply Chain Security Act to facilitate tracing products through the pharmaceutical distribution supply chain by requiring trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) to exchange transaction information, transaction history, and transaction statements when engaging in transactions involving certain prescription drugs. The [guidance](http://www.fda.gov/Downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM598734.pdf?ref=fdaweb.com) also addresses how the product tracing requirements apply to certain prescription drugs that entered the pharmaceutical supply chain before 1/1/15.

“This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners must provide, capture, and maintain…,” the document says. “This guidance is also intended to help trading partners understand the data elements that should be included in the product tracing information, particularly in situations where trading partners are permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required. In addition, this guidance recommends documentation practices that trading partners can use to satisfy the product tracing requirements….”

Also released was a draft [guidance](http://www.fda.gov/Downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM598737.pdf?ref=fdaweb.com), *Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act*, interpreting the terms used in the Drug Supply Chain Security Act definitions of “suspect product” and “illegitimate product” to assist trading partners in meeting verification obligations, including notification.