Enforcement Sanctions of DSCSA Postponed: Opportunity to Look Beyond Compliance

Adents was the first to report on the fact that the US Food and Drug Administration (FDA) seems to be willing to give the pharmaceutical industry an additional grace period concerning the implementation of some of the Drug Supply Chain Security Act (DSCSA) mandates and to issue expert advice on the subject.

In light of the fact that a large majority of American drug manufacturers still hasn’t even started to implement a viable serialization solution, the Federal Drug Agency seems to have listened to industry concerns and has recently published a new draft Guidance document on “Product Identifier Requirements Under the Drug Supply Chain Security Act”.

The newly published document implicitly gives pharmaceutical companies and CMOs an additional year to implement serialization for prescription drugs. While the official deadline of November 2017 is maintained, the Guidance document says that the “FDA does not intend to take action against manufacturers who do not, prior to November 27, 2018, affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce as required by section 582(b)(2)(A) of the FD&C Act.” This means that you still should have an operational serialization solution in place by November 2017. However, penalties will not be applied before November 2018 if you can’t meet the legal deadline.* The fact that the document has only been published as a draft however means that changes are still possible!

A delay in the enforcement date will provide invaluable time for pharmaceutical companies and contract manufacturers to look beyond short-term compliance needs and consider long-term solution viability. Take the time to think about what your serialization solution should provide to make the investment worthwhile and do not just opt for the quickest to implement short-term solution.

A flexible, hardware-agnostic serialization solution with strong Level 3 applications that offers central configuration of current and future regulation parameters provides for adaptability as well as scalability. Furthermore, central configuration will speed up changeovers and minimize risk of human error at line level.

However, now that you have a bit more time to make an informed decision, you should envisage a solution that takes your serialization data to the next level. With a Cloud-based Level 4 track&trace solution that helps you keep control of your serialization data across all your sites, allows connectivity with authorities as well as partners (3PLs, CMOs or pharmaceutical companies) and comes with strong data analysis capabilities. Thus, you can turn your serialization data into vital business information to improve processes, communication with customers and patients, optimize your supply chain and more.

For further insight, have a look at our related news article. Should you wish to discuss the way forward towards serialization compliance, please get in touch with us here.  We are happy to help!

*For detailed information, we urge you to consult the original guidance document published by the FDA.