Postponement of the introduction of drug serialisation in the US market

The Drug Supply Chain Security Act (DSCSA) comes into force on 27 November 2017. In the US market, drug product units and packaging must then be labelled with a unique serialisation code. Serialisation software provider Adents is campaigning for the remaining time to be used for sustainable solutions.

The Drug Supply Chain Security Act (DSCSA) comes into force on 27 November 2017. In the US market, drug product units and packaging must then be labelled with a unique serialisation code. However, the mandatory implementation of the law has now been postponed by a year. Serialisation software provider Adents is campaigning for the remaining time to be used for sustainable solutions.

Manufacturer of Medication, sold in the USA must ensure that the supply chain is fully traceable from 27 November 2017. All prescription sales units and homogeneous packaging must be labelled with a unique Product identification code be equipped. Because especially smaller Supplier company were unable to implement the necessary hardware and software in time, the US Federal Food and Drug Administration (FDA) announced on 30 June that it would postpone the implementation of the law. Although the so-called „Drug Supply Chain Security Act“ (DSCSA) comes into force as planned. However, affected companies now have one year longer, namely until 27 November 2018, to retrofit their technology.

Especially companies that have not yet opted for a Serialisation process should think about a sustainable solution within the remaining year. This is what Adents, one of the leading providers of serialisation and track & trace software solutions, is promoting. According to the company, it is not yet clear how future requirements will develop. In future, more flexible, hardware-independent serialisation solutions that can be adapted and upgraded are likely to be in demand.

Even if serialisation projects have already been initiated, the postponement will provide the opportunity to introduce tools that make better use of the data volumes resulting from the serialisation requirements than previously envisaged. [infotext]

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Future-proof serialisation solutions from Adents

You can find more information on the hardware-independent serialisation software package from Adents in this current article, who is also Packaging Journal 6/2017 has appeared[/infotext].

In this context, Adents refers to its own hardware-independent serialisation and aggregation software package. This already fulfils the current requirements for Product traceability and Documentation and is equipped for future regulations. Adents' solutions are based on an ideally standardised approach and are extremely flexible, scalable and quick to implement, as configuration takes place entirely at site level. A separate configuration per line becomes unnecessary.

CEO Christophe Devins also emphasises these advantages of Adents solutions and adds: „In addition, our solutions allow you to derive additional business value from the incredibly large amount of data generated for serialisation purposes.“