Standardization of Data and Documentation Practices for Product Tracing; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Standardization of Data and Documentation Practices for Product Tracing." The draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements (product tracing information) provided under the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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 under the FD&C Act. In addition, this guidance includes recommendations for documentation practices that a trading partner can use to meet its product tracing obligations, including in situations where a trading partner is permitted by law to provide other trading partners with product tracing information that omits certain elements that would otherwise be required.