FDA seeks input on data exchange in drug supply chain

US flag and gavelThe US FDA is asking for comments on standards that could be used to exchange transaction data as medicines move along the supply chain.

The request is part of the implementation of the Drug Quality and Security Act (DQSA) and specifically Title II of that legislation - known as the Drug Supply Chain Security Act (DSCSA) - which aims to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US.

The FDA issued a timeline chart for the implementation of the DSCSA last week, and the issuance of a public docket to collect comments on data standards was the first entry on the list.

Other targets this year include the publication of guidance on the standards - as well as guidance on how to identify suspect products - and establishing systems for third-party logistic provider and wholesale drug distributor reporting to the FDA.

The Federal Register notice indicates the FDA wants input from "drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organisations, state and federal agencies, and solution providers" on the data standards.

"The ability to track and trace finished prescription drugs plays a significant role in providing transparency and accountability in the drug supply chain," it adds.

According to the definitions laid out in the DSCSA, 'transaction information' covers the name, strength and dosage form of the medicine, its national drug code (NDC) number, the container size, lot number, date of transaction, date of shipment, and the names and addresses of the shipper and recipient of the drug.

The agency wants information on the types of information already collected by supply chain stakeholders, both in electronic and paper format, and whether they are interoperable. It is also asking for comment on challenges and obstacles to data sharing and notifications of suspect product, amongst other things.

The deadline for comments is April 21.

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