FDA says DSCSA pilot complete, as deadline nears

The FDA has published its final report on the Drug Supply Chain Security Act (DSCSA) pilot programme, which it says will be used to inform implementation of the requirements of the legislation.

First enacted in 2013, the DSCSA is designed to create a more controlled, closed prescription drug distribution system to prevent counterfeit, stolen or otherwise illegal medicines from entering the supply chain, locate harmful drugs if they do, and make it easier to pull them from distribution quickly.

Overall, the report on the 20 individual pilots carried out under the programme suggests that the industry has made “significant progress” towards being in compliance with the DSCSA by November 27, the date for full implementation of unit-level tracing of medicine packs through the supply chain from maker to dispenser, fuelled data exchange between trading partners.

After that date, pharmaceutical manufacturers, wholesale distributors, third-part logistics (3PL) companies and pharmacy dispensers will have to ship, receive and manage serialised medicines, connecting with trading partners via GS1 Electronic Product Code Information Services (EPCIS) to provide complete track-and-trace aggregation.

Among the lessons learned in the pilot programme was the demonstration that interoperability could be achieved in a number of different ways, either into one platform centralised or decentralised across multiple, and ways in which trading partners can balance supply chain transparency with data security.

It also reinforced the need for standardised processes for handling and sharing data, but also pointed to the potential for standardisation in areas not covered by law, such as handling exceptions like overages of clerical errors in documentation – which has emerged as a major challenge facing the industry.

Changes to some business and operational procedures are inevitable, technical obstacles are likely, and businesses must allow sufficient time to onboard their suppliers and customers, says the document.

Readiness in question

There are still concerns that some parts of the supply chain will struggle to meet the deadline, particularly distributors which will have to connect to a broad array of manufacturers and dispensers, and an underbelly of smaller trading partners who may be either unaware of the requirement or simply too late to reach compliance in time.

The Healthcare Distribution Alliance (HDA) and the American Pharmacists Association (APA) have both asked for enforcement discretion from the FDA after November 27, to give late adopters more time to get up and running and avoid the risk of medicine shortages.

While the APA is seeking a blanket enforcement holiday, the HDA would like it to be focused, granted only to specific products, to avoid a situation where noncompliant companies simply drag their heels again.