FDA sets May date for first DQSA workshop

The US FDA has organised the first of a series of public workshops designed to guide the implementation of the Drug Quality and Security Act (DQSA).

On May 8-9, the agency will host a meeting to discuss standards that could be used to exchange transaction data as medicines move along the supply chain, one of the pillars of Title II of the DQSA.

The act gives the FDA one year to publish a draft guidance document that establishes standards for the interoperable exchange of this data, and the agency has already asked for public comment on the possible requirements.

The workshop on Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format is intended to "gather information, current practices, research and ideas," according to the agency. All told the agency expects to conduct at least five public meetings during the implementation of the DQSA.

In addition to the standards that can be used to exchange transaction information, transaction history and transaction statements between supply chain actors, discussions may also focus on other topics such as: "the exchange of information between supply chain stakeholders to provide, receive, and terminate notifications, and how trading partners should respond to requests for verification of suspect drug product."

It may also consider ways to respond to requests for information from FDA or other official agencies "in the event of a recall or for the purpose of investigating a suspect or illegitimate drug product."

Registration information is available here.