Drug Supply Chain Security Act (DSCSA): Countdown to Compliance
The pharmaceutical industry is facing an epidemic. Counterfeit drugs make up 10% of the drug market worldwide.1 Drug thefts amount to well over US$1 billion annually.2 In response to these pressures, the Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), is now in countdown mode: manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers are required to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
It is important to understand that the deadline for compliance with DSCSA serialization requirements was November 27, 2017. While the FDA has chosen to delay enforcement of these requirements until November 27, 2018, all affected organizations should already be complying with the DSCSA guidance. The delay simply gives organizations a grace period to come up to speed on DSCSA.
The grace period was welcomed by many, as DSCSA requires the following per the FDA website:
- Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
- Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
- Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
- Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
- Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA within 48 hours and other stakeholders if an illegitimate drug is found.
To summarize these mandates in a single word, DSCSA is about data: collecting it, securing it, and transmitting it through every step of the supply chain.
Unisys is already prepared for DSCSA – and is actively helping impacted organizations worldwide to electronically transmit transaction information, histories, and statements. The tight timelines for reporting exceptions set by the FDA impact all members of the supply chain. PharmaTrack™ from Unisys secures and illuminates the entire pharmaceutical supply chain, providing end-to-end supply chain oversight in real time. The system quickly and easily identifies product authentication issues anywhere along the supply chain, and facilitates investigation and remediation. In addition, PharmaTrack provides supply chain agents with the ability to help prove that the pharmaceuticals they accepted and subsequently handed off to the next agent were not compromised on their watch and enables agents to meet the FDA reporting guidelines without undue burden.
All data tracked and transmitted by PharmaTrack is protected with Unisys Stealth®, a security portfolio that uses software-based cryptography and microsegmentation to prevent unauthorized access to sensitive information and make endpoints invisible to unauthorized users.
As a respected name in the healthcare and transportation industries, Unisys has years of experience delivering value to pharmaceutical organizations. Ultimately, PharmaTrack benefits every stakeholder in the pharmaceutical supply chain by getting medications from manufacturers to patients without disruption or hazardous consequences. We stand ready to help organizations come into compliance with DSCSA and so protect the lives and well-being of the patients they serve.
2 Freight Watch International, http://www.iosrjournals.org/iosr-jce/papers/Vol19-issue2/Version-4/P1902048388.pdf