FDA takes steps to enhance drug supply chain security; setting new data standards to identify, trace packages

The FDA  The “Standardization of Data and Documentation Practices for Product Tracing” draft guidance elaborates on the standards for the interoperable exchange of transaction information, transaction history and transaction statements (product tracing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. The “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act” draft guidance describes the FDA’s interpretation of terms used in the definitions of “suspect” and “illegitimate” products in the DSCSA to help trading partners meet their verification obligations, which includes notifying FDA. The draft guidance presents the FDA’s current understanding of the terms counterfeit, diverted, fraudulent transaction and unfit for distribution. FDA is also holding the third meeting in its series titled “Enhanced Drug Distribution Security under the Drug Supply Chain Security Act” to discuss strategies and issues related to the enhanced drug distribution security provisions of the DSCSA.  Both guidances are open for comments via the dockets: Standardization of Data and Documentation Practices for Product Tracing Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act