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How US Drug Supply Chain Security Act Impacts Comparator Sourcing


By: Jürgen Karg March 08 2017

Tags: Comparator, Global Distribution

US Drug Supply Chain Security

In a recent audit a new supplier was not qualified as compliant according to the Drug Supply Chain Security Act (DSCSA). This provider was declined by Fisher Clinical Services as a new supplier of comparator drugs (subsequently named reference drugs) for clinical trials. I would like to dedicate my blog today to “the positive impact of the DSCSA on clinical trials”.

Let me explain first, what the new regulation is and how it impacts clinical trials.

The Drug Supply Chain Security Act (DSCSA) has been effective since May 1st 2015. Under the DSCSA, manufacturers, wholesalers, drug distributors, re-packagers, and many dispensers in the drug supply chain must keep and disclose information about a DSCSA product whenever a change of ownership occurs in the US market.

The new law applies to certain Food and Drug Administration (FDA) approved or licensed prescriptive drugs and biologics. You can find a list of the types of products that are exempt from DSCSA requirements here -

The new act is restricted to human drugs in finished dosage form that are sourced, delivered and sold in the US market. Consequently the regulations are not applied in cases where the reference drug is imported or exported to or from the US. Among other products, investigational products (IMP) are officially exempt from this act. However, reference drugs are affected by this act, because the reference drug, the rescue drug, and co-medication are commercially available drugs at the point of purchase.

In order to be compliant, the complete industry had to adapt as of May 2015. I personally believe that the effort for adapting to the new requirements was smaller than expected for the whole industry. Besides the initial adjustment of the internal Standard Operating Processes, the additional workload for sourcing through the originator is now insignificant from a QA point of view. This is because it was already a very common service to deliver the pedigree together with the reference drug.

However, the impact of the DSCSA on sourcing through the open market is much higher as some suppliers fear they will be sidestepped. Indeed a small number of suppliers have been reluctant to provide the more detailed information according to the new regulation. But if a single party in the supply chain cannot provide a stepwise pedigree and they sell a drug into the network, they are not complying with the DSCSA. In summary, reassure that your supplier is compliant in order to be compliant yourself.

In my opinion this new act will help increase the safety of the supply chain by revealing the history of drug sales, reduce the number of handoffs and reduce the risk of counterfeits in the network. I am sure that this has a positive impact on patient safety within the commercial marketplace and also within the clinical supply chain. This is sure to become evident in upcoming statistics. Fisher Clinical Services has provided full transparency on the supply chain back to the manufacturer in accordance with the DSCSA since day one of the introduction of this new law. Personally, I am convinced that a positive side effect of this new act will be the reduction of intermediaries per transaction. Minimizing hand-offs helps maintain product integrity and can often result in cost and performance efficiencies. “The shorter the better” is not only true for the route of supply but also for blog articles. I will stop writing now!

You can check out this other blog that may be of interest to you:

Procurement of reference drugs – Russian Roulette in the Clinical Supply Chain