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The 1st May, 2015 deadline for securing compliance with the DSCSA data transaction exchange requirements has begun. Most recently, the results of 2015 US Pharma Traceability Survey carried out by RxTrace, an independent consultancy, were made public. The findings of the survey are an important step towards quantifying the overall industry progress towards serialization and DSCSA compliance. Here’s a wrap up of the most noteworthy findings from the survey.
The first significant finding from the survey indicates that majority of the companies believe they possess a thorough understanding of the transaction data-exchange requirements laid down by the FDA in the Drug Supply Chain Security Act. To be precise, around 77% of the respondents claim to have read enough or all of the DSCSA to know what their company needs to do to meet the compliance requirements. That still leaves behind around 23% of the participants who either still need to learn more or are totally unaware of the new Federal requirements that are all set to have an impact on how their companies operate.
The second important finding states that around 40% of the companies involved in the survey consider themselves adequately prepared for meeting the requirements laid down in the DSCSA. On the other hand, 24% of respondents represented companies that just may or would not be able to meet the transaction data exchange requirements within the stipulated timeframe.
Another important inference from the survey is the time period spent by companies in preparing for securing compliance with the DSCSA. A whopping 22% of the participants reported to have started working on securing compliance in the last six months, whereas 16% of the partakers said they’ve just started working or, worst, are yet to start preparing for the requirements of the DSCSA.
Yet another deduction from the survey is that manufacturers and packagers that are yet to add serialization capabilities have an impractical idea of the time it takes to cultivate and deploy the required compliance updates to their operations. Furthermore, around 35% of the respondents reported to have not begun on adding components necessary to serialize the drugs they manufacture or repackage.
As to what is it that has held companies from starting to work towards serialization:
lack of understanding of the FDA guidance,
being a newer company,
and expecting a further delay in the serialization deadline have been reported as the main reasons.
Also, only a small percentage of the respondents felt that only a small percentage of those calling the shots in their respective companies clearly understood the DSCSA and the relevant FDA guidelines.
The results paint a gloomy picture. There is an excess of technical challenges manufacturers, re-packagers and wholesalers are facing as they choose the best serialization solution for their companies. Remember, if you are a wholesaler or a dispenser, the serialization data will come from the manufacturer. It’s important to have a ready system in place that can easily receive this data and display it in a clear concise way to be optimized to meet your supply chain work flow. Delivering this feature solution might sure be difficult, but it is by no means impossible.