OPTEL details the law on the security of the drug supply chain
Drug counterfeiting is a long-standing global problem, and the USA perhaps has the worst of it. According to the PSI (Pharma Security Institute), cases of drug counterfeiting, theft, and illegal diversion rose to an all-time high of 4,405 worldwide in 2019, twice the number reported in 2014. North America saw the largest number of seizures (1,750) due to counterfeit drugs in the year, followed by Asia.
To combat this growing problem and to reinforce the security of the drug distribution chain, the FDA introduced the Drug Supply Chain Security Act (DSCSA). Signed by then President Obama on November 27, 2013, the law follows a 10-year, phased implementation plan with yearly compliance deadlines. Some costly and challenging deadlines are already behind us. However, the most complicated ones are yet to arrive.
If you’re part in the pharmaceutical industry, an understanding of this critical law and its implications is essential to gauge your organization’s DSCSA readiness.
We present a complete guide to DSCSA, crucial timelines, and the mandated requirements.
WHAT IS THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)?
In 2004, the State of California took the first steps towards making prescription drugs safe for patients, with serialization being at the center of these efforts. All pharmaceutical manufacturers and suppliers in the state were required to serialize individual packages and provide electronic proof of origin for every product that traveled through the supply chain.
The idea behind this initiative was to make it easy to detect forgeries and initiate recalls if need be.
Witnessing the success of the method in California, the FDA filed for a nationwide solution against drug counterfeiting in the form of the Drug Supply Chain Security Act (DSCSA).
Essentially, the law outlines vital requirements towards building a complete electronic system for tracking and identifying prescription drugs on sale in the US. The law envisions:
- Interoperable, electronic exchange of Transactional Statements and Transactional Information between members of a pharmaceutical supply chain
- Interoperable tracing of Transactional Statements and Transactional Information back to the manufacturer for each unit sold
- Interoperable verification of the Product Identifier, including the serial number, lot number, GTIN/NDC, and expiration date
The focus here is interoperability. DSCSA strives to provide a smooth, secure, and confidential data flow amongst trading partners.
WHY IS DSCSA IMPORTANT FOR YOU TO UNDERSTAND?
Ready or not, the DSCSA will be in full force come November 2023. Though it may seem like a typical compliance requirement, it can save the Pharmaceutical industry significant time and resources. How? With easily accessible data, tracking packages across the supply chain becomes easy, allowing a secure, trustworthy, and efficient distribution.
Although the FDA has suspended prosecution for those who don’t abide by the DSCSA requirements, it can crackdown on defaulters at the end of the suspension.
So, it’s important to review your organization’s progress regarding compliance and take the necessary steps.
Non-compliance can lead to fines, suspension of your license, or in the worst of cases, imprisonment or civil penalties.