A new Legislation in the USA gives more Power to the FDA in the Fight against Counterfeits

In the USA, President Obama signed into law the "Drug Quality and Security" (H.R.3204 - Drug Quality and Security Act) at the end of November 2013. This act gives much more authority to the FDA to build a system for the traceability of medicinal products (supply chain integrity). This traceability system should include all information down to the package level.

Beside the modified requirements with regard to "pharmacy compounders", the new act also presents a plan on how to implement a unified standard which should lead to an electronic system over a 10-year period ensuring the traceability of each single medicinal product all over the country. According to this, serialisation of all medicinal products is planned.

Wholesale drug distributors are expressly involved. For them, the FDA will manage a public database.

In February 2014, the FDA published a timetable for the implementation of the new Act.  You will find more in the "Drug Supply Chain Security Act (DSCSA) Implementation Plan".

According to this plan, all the measures for the implementation should be in place within a decade.

Conference Recommendations

Go back

GMP Conferences by Topics