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Drug Supply Chain Security Act by FDA: what do you need to know?

On June 30 this year, FDA published draft guidance for product identifier requirements under the Drug Supply Chain Security Act (DSCSA). This article is going to identify main areas of FDA DSCSA, look into delay of its enforcement and suggest solutions to make sure that your company is compliant before the deadline.

Product identifier requirements by FDA

As per draft guidance for pharma industry by FDA, manufacturers (as well as other supply chain stakeholders) are informed that they need to start including a product identifier on prescription drug cases and packages on November 27 this year. However, the FDA is delaying enforcement of those requirements until next year (November 2018) so that manufacturers have more time for implementation and prevention of supply chain disruptions.

How FDA defines product identifier?

According to FDA product identifier in pharmaceuticals need to have following attributes:

  • Provide a unique identity for separate prescription drug packages and cases
  • Allow all stakeholders to easily trace drug packages throughout their movement in the supply chain
  • Include drug’s LOT number
  • Include expiry date
  • Include national drug code (NDC)
  • Include a serial number (this will be different for each package/case)
  • Have a unique identifier that consist of LOT, expiration date, NDC and serial number that is recognized by both – human and machine

FDA points out that product identifier will help to recognize illegal products within the supply chain in a more sufficient manner.

Has the DSCSA law been delayed by FDA?

As discussed above, FDA is delaying enforcement of product identifier requirements until the next year. However, this does not imply that FDA DSCSA law has been postponed too – it will go into effect November 27, 2017 and non-compliance could still be penalized.

In simple words, deadline for compliance has not been changed, yet FDA will give pharma companies one extra year to overcome challenges related with product identifier, as serialization is a complex process.

What are the advantages of the delay then?

If non-compliance can still be penalized by FDA, are there any benefits of the delay? Yes - we listed couple below.

  • Incredible opportunity for those who haven’t installed a solution yet, as they can learn from the mistakes made by competitors
  • Good time to change service or solution for those who regret their decision
  • Perfect phase to walk through learnings and adjust working practices if needed for those who are already prepared for the compliance

What approach shall I take?

This year Pharma Packaging & Labeling West Coast will cover topics related with FDA DSCSA delay and help you to fully understand what is happening in the pharmaceutical industry and how to be compliant.

Whether you have already tried any serialization solutions or have no resolution yet – this year’s event will gather pharma experts and service providers to help you to select best innovation based on long term strategy. Get ready for FDA DSCSA and stay ahead of ever-increasing competition by joining your industry peers this November in Burlingame, California.