What is the future of drug traceability?
by Maureen Perroni, on April 1, 2016
As it is implemented over the next decade, the Drug Supply Chain Security Act (DSCSA) will, piece-by-piece, create a track-and-trace system for pharmaceutical drugs distributed in the United States.As it is implemented over the next decade, the Drug Supply Chain Security Act (DSCSA) will, piece-by-piece, create a track-and-trace system for pharmaceutical drugs distributed in the United States. When completed, this system will make it possible to verify the legitimacy of every drug package in the supply chain, while recalling illegitimate products.
The new rules will present a challenge for pharmaceutical distributors, especially smaller operations. To avoid being put in a costly situation, they will need to streamline their processes while complying with the regulation.
The specific processes in question depend on which areas need to be upgraded to be in compliance. The DSCSA requires a number of different actions from distributors. They will have to know where each drug is received and sold, who it is sold to, and how much of its shelf life remains at the time of sale. They will also have to report each sale using a nationwide coding system.
Creating and updating labels and keeping records manually can lead to numerous errors and inefficiencies. An Enterprise Labeling Solution replaces error-prone manual efforts with a centralized, automated system. This allows for greater flexibility in the face of labeling change requests — an all-too-present reality during a decade-long regulatory rollout.
At the moment, the pharmaceutical industry is only required to comply with lot-level traceability rules. Product serialization will go into effect in 2017, and a fully electronic traceability system will become active in 2023. There will be many steady changes to pharmaceutical labeling rules along the way, and Enterprise Labeling will make them easier to deal with.
For more information on Pharma labeling download our customer webinar with Ferring Pharmaceutical.