SERIALIZATION & BEYOND...

On October 24, 2018, FDA issued the following guidance document: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (Draft Guidance).

Manufacturer Serialization Readiness Survey Results toward DSCSA Implementation, and Verification Router (VRS) Service

As part of HDA’s VRS task force, Adents successfully completed end-to-end testing for Verification Request routing including Look-up Directory synchronization. Adents VRS, developed in partnership with Microsoft, is the unique solution currently tested by 4 of the top 5 largest Pharma wholesalers in the US.

The FDA has issued one draft and two final DSCSA guidance documents

At Adents, we consider blockchain to be the best long-term technology for a Verification Router Service to meet the US DSCSA requirements, but we understand that it is not a quick and easy path to navigate.

Did you know that on average, 60 million pharmaceutical saleable product returns, equaling $7-8 billion dollars, occur each year in the US market? This year, the establishment of shared standards for sales stream reintegration has become vital for the pharmaceutical industry.

The US organization Healthcare Distribution Alliance (HDA) has built a central product master data repository called HDA Origin.

“Grandfathering policy for packages and homogenous cases of product without a product identifier” is an FDA guidance document published in November 2017.

The US Food and Drug Administration (FDA) seems to be willing to give the pharmaceutical industry an additional grace period concerning the DSCSA.

FDA does not intend to take action against manufacturers who are not fully serialized by November 2017.

The US Food and Drug Administration (FDA) has published guidance documents to help MAHs and CMOs navigate the Drug Supply Chain Security Act (DSCSA)

While the challenges of DSCSA compliance are undeniable, the right serialization and traceability solution can offer a multitude of benefits.

Even though the deadline for DSCSA compliance is only 6 months away, there is still some uncertainty as to who exactly will be concerned when by its requirements.

The Drug Supply Chain Security Act (DSCSA) will require many changes for your business and some of them will be highly complex. Change equates to risk. The greater the impact, the higher the level of risk.

If you cater for the American market, you need to start putting together a serialization implementation strategy now if you want to be compliant and operational in time with the DSCSA requirements.

When serializing your products, you need to double-check the quality of your printed codes to ensure your supply chain can read them.

It is pretty clear that serialization at unit level is mandatory from November 2017 under the Drug Supply Chain Security Act (DSCSA). But what about other packaging levels?