Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk. As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.)
Signed by President Obama in 2013; with a 10 year implementation plan in place larger drug manufacturers have already begun traceability and serialization process improvements. While there have only been guidance deadlines issues so far we are approaching our first FDA meeting to get feedback on its track and trace requirements.
Ensuring patients are receiving authentic, uncontaminated drugs is the FDA’s and drug manufacturers number one priority. While we still have until 2024 until full compliance is mandatory, manufacturers and regulatory bodies are working hard to meet these standards.
Look forward to more updates and news on the DSCSA from Pragmatyxs.