FDA's first DQSA track-and-trace workshop will be held May 8-9
First of many meetings to come that are required by the Drug Supply Chain Security Act
FDA has posted a Federal Register announcement of a public workshop to be held May 8-9 at its Silver Spring, MD, campus. This is the first of many meetings that are specified in Title II of the Drug Quality and Security Act passed last November (Title II is being called the Drug Supply Chain Security Act, or DSCSA, by FDA).
The subject of the meeting is: “Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format,” which refers, at one level, to how barcode information on drugs are to be incorporated into packaging, and at another level to a trio of regulatory items, “Transaction Information,” “Transaction History” and “Transaction Statement,” that are the documentation of product movement through supply chains. FDA has had a docket open since February soliciting comments on these topics.
Registration information is available here.
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