Pharma 'will not meet serialization deadline in US'

A new survey has found that pharma companies will not be able to meet the target of providing 100 per cent serialized medicine packs by the November 2017 deadline in the US.

The poll by the Healthcare Distribution Alliance (HDA) suggests that manufacturers will have made significant headway, however, with 89 per cent of them saying they expect to be sending some serialized product to wholesale distributors before November 27 next year.

Under the Drug Supply Chain Security Act (DSCSA) mandate, by that date drug manufacturers will have to mark packages with a product identifier, serial number, lot number and expiration date, using a 2D datamatrix barcode.

Around two thirds of drugmakers – including generic and branded drug producers - indicated that 100 per cent of products shipped will be serialized by the deadline, while around 90 per cent said that at least half will be compliant with the requirements.

Four out of 10 expressed concerns about the requirements, however, saying they were worried that contract manufacturing organisations (CMOs) will not be prepared in time and also about a lack of FDA guidance on serialization requirements.

Interestingly, manufacturer serialization readiness for both branded and generic products was not found to be correlated with the number of stock-keeping units (SKUs) they sell, and more than a third said they intend to start sending aggregated data to wholesalers by the November 2017 deadline.

Aggregation involves linking the individually coded packs within the codes used on cartons, cases, and pallets used in shipping, and is acknowledged to add considerable complexity to the process of implementing serialization on packaging lines. It not explicitly required in the DSCSA but is expected to be an operational requirement when the Enhanced Drug Distribution Security (EDDS) stage comes into effect in 2023.

A third of those polled said that aggregated data will be sent between November 2017 and November 2023, while just over a quarter (26 per cent) indicated they have not determined a date for aggregated data to be sent.

"Overall, the survey indicates that manufacturers are working diligently to serialize products," says the HDA, but "it is clear that 100 per cent of product will not be serialized by November 27, 2017."