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‘Unrealistic’ serialization deadline? FDA offers one year grace period

By Flora Southey , 04-Jul-2017
Last updated on 04-Jul-2017 at 17:48 GMT2017-07-04T17:48:09Z

iStock/Kuzma
iStock/Kuzma

The US Food and Drug Administration (FDA) has released draft guidelines offering a reprieve for manufacturers which have not integrated product identifier requirements by the November 26 serialisation deadline.

The draft policy asserts action will not be taken against manufacturers who do not affix or imprint a product identifier to each package of prescription drugs before November 26, 2018.

“The FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions,” FDA spokesperson Lyndsay Myer told in-PharmaTechnologist.

The policy also accommodates downstream trading partners, who may wish to purchase products without a product identifier prior to November 2018.

“FDA does not intend to take action against a repackager, wholesale distributor, or dispenser that engages in a transaction involving such product, except where a repackager’s transaction triggers an independent responsibility to affix or imprint a product identifier,” the guidance states.

‘Unrealistic’ deadline?

However, US director of serialisation technology provider SEA Vision, Carlos Machado, told in-PharmaTechnologist the original cut-off date was unrealistic.

"The confirmation of the delay to the FDA’s enforcement of the Drug Supply Chain Security Act (DSCSA) from November 2017 to November 2018, demonstrates that the initial deadline was not realistic for all manufacturers,” he said.

“While the majority of big pharma companies have already implemented serialisation solutions, some small and mid-sized manufacturers are yet to make a start,” he added.

Pharma unprepared?

Industry has expressed concern that pharmaceutical companies, and in particular contract manufacturing organisations (CMOs), are unprepared in light of impending serialisation deadlines.

Machado also said pharma is lagging in adopting serialisation legislation, and advised companies to act quickly.

“SEA Vision and Zenith Technologies recently undertook some industry research that revealed that more than a third of companies are not currently preparing for serialisation, despite the looming deadlines in the US and the European Union,” he told us.

“This extension does provide the industry with more time to prepare and implement the right solution, however companies should not be complacent and need to act now to ensure that they meet the new deadline,” said Machado.

The suggestions have been issued just five months before the original US Drug Supply Chain Security Act (DSCSA)-enforced cut-off date, on November 26.

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