DSCSA deferral on medicine disruption fears

FDA building signThe US FDA has delayed the deadline for the transfer of transactional data between parties in the medicines supply chain after hearing that some shipments may be disrupted.

The agency announced in the Federal Register that it was deferring some of the requirements of the Drug Supply Chain Security Act (DSCSA) - due to come into effect on January 1 to May 1 - because "some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the pharmaceutical supply chain, and ultimately could impact patients' access to needed prescription drugs."

Specifically, the decision affects manufacturers, wholesale distributors, and repackagers who have a little longer before they have to start providing or capturing the transaction information, transaction history, and transaction statement required under the DSCSA.

Companies must still comply with other provisions of the act, such as verifying suspect and illegitimate products, as well as ensuring they only do business with registered companies.

The US regulator did not suggest the delay would have any effect on the compliance deadline for dispensers, who are scheduled to start collecting data by July 1, or indeed the 2017 deadline for assigning serial numbers to individual packs of prescribed products sold in the US.

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