The legislation - the Drug Quality and Security Act – charges the US regulatory agency with the development of a means of tracing drug products throughout the supply chain to try and minimise the risk medicines are contaminated or that fake products make it to pharmacy shelves.
The new law – which was approved by the US House of Representatives in September and the Senate late last month – makes efforts of States like California to create track and trace redundant and prevents the development of differing rules across the country.
According to the FDA, all pharmaceutical firms will be required to add serial numbers to all packages in the next four years. These labels must be upgraded to electronic codes in the next ten years. Further details have not been announced.
Industry response
The new law has been welcomed by the drug industry. US industry organisation PhRMA said: “This Act will improve the security of the finished drug supply chain and reduce the impact of the patchwork of state laws related to the pedigree requirements for drug distribution.
A single system of track and trace in the US has also been well received by European drugmakers that supply the market.
in-Pharmatechnologist.com visited Sweden this week for a tour of Recipharm’s packaging facility located just outside the capital Stockholm. While the visit focused on the CDMO’s abilities to package drugs for shipment to markets worldwide, relief about the US track and trace decision was evident.
Site manager Ulf Hagström told us that: “We like many drugmakers were concerned that there would be many different systems in the US, but now with this new legislation all the States will have the same track and trace requirements which is a positive thing.”
Recipharm CEO Thomas Eldered, who accompanied in-Pharmatechnologist.com on the tour, also welcomed the laws as a good thing for customers making drugs for the US market but did point out that, although the rules will be harmonized across that country, the new track and trace system will be different to the one in place in Europe.
This was echoed by EFPIA director general Richard Bergström who told us that: "Europe is already well under way, ahead of the US, thanks to its development of a system [the European Stakeholder model] in which each medicine pack is checked when it is dispensed at the pharmacy, ensuring that the patient receives the genuine product.
"As we allow free flow of goods, all manufacturers, wholesalers and pharmacists must be linked to the system. In Europe these stakeholder have agreed to work together to implement a system that is safe, easy to use and cost-effective. The European experience can guide our US colleagues."
Compounding
The Drug Quality and Security Act also seeks to make clearer how compounding pharmacies – which produce drugs on site – are regulated.
Previously the rules governing compounding pharmacies were muddled. Drug manufacturing is of course regulated by the FDA. Pharmacies on the other hand, including those that compound drugs, were regulated at State level.
Under the laws large compounding pharmacies can register with the FDA and ask for operations to be inspected, however smaller firms will continue to be regulated by state boards. For those that do register the FDA will be able to track their products.