November 26th was supposed to be the start of the new serialization policy under DSCSA. But last June 30th, FDA issued a draft guidance for the industry & product identifier requirements. DSCSA – drug supply chain and security act to apply to all companies. On that day FDA delayed enforcement of those requirements until November 2018 to provide additional time to manufacturers and prevent from potential disruptions. Indeed, it appeared that many SME’s were not ready. So yes, you still have an additional year to comply.
In Europe, serialization deadline is fixed for February 2019 and countries like Belgium already fixed a timeline for implementation. In that context, should global organizations set standards in place for a global compliance? The answer is mostly yes.
A product identifier?
- Is a unique identity for individual prescription drug packages and cases. It will allow partners along the value chain to trace drug packages.
- Includes: product lot number, expiration date, national drug code, serial number. Each package has its own serial number. This unique identifier will allow to detect illegitimate products within the supply chain.
Learn from the Turkey case
Turkey has been one of the pioneers in implementing drug traceability. Getting a feedback on their experience is valuable as state representants do estimate today that gains for the country is worth billions of dollars.
Benefits from serialization are safer medicines, prevention of resale, expedition of recalling, prevention of drug shortages, quality data for insurances, enables pharmacovigilance and strategic planning.