The “Standardization of Data and Documentation Practices for Product Tracing
” draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history and transaction statements (product tracing information). The interoperable exchange of transaction information is the ability of trading partners to exchange product tracing information accurately, efficiently and consistently in a usable format. Currently, this is being done in paper and electronic form, but beginning in 2023, it will be exchanged only electronically. The agency intends for this guidance to assist trading partners in the drug supply chain, from manufacturers to pharmacies, by standardizing the data in the product tracing information that they must provide, capture and maintain. In addition, this guidance recommends documentation practices a trading partner can use to meet its product tracing obligations, including in situations where they are legally allowed to omit certain product tracing information they give to other trading partners.
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