TLDR DSCSA | December 2024 🎄
The most interesting DSCSA stories and news for the month of December.
🏢 Industry
Did Industry Fumble the DSCSA Deadline?
⚡TLDR: Despite years of preparation, FDA enforcement of the DSCSA has been delayed again, revealing significant gaps in data interoperability and readiness across the industry. While 99% of drug shipments carry barcodes, missing or mismatched data remains a bottleneck, forcing the supply chain to rely on manual "exceptions handling" processes. Experts urge stakeholders to resolve these data gaps now to avoid further delays and ensure uninterrupted product flow.
Giant Companies Took Secret Payments to Allow Free Flow of Opioids
⚡TLDR: A New York Times investigation reveals that major pharmacy benefit managers (PBMs) accepted billions in payments from opioid manufacturers, like Purdue Pharma, to avoid imposing restrictions on painkiller prescriptions, fueling the opioid crisis. These "pay-to-play" deals prioritized financial incentives over safety measures, enabling unrestricted access to drugs like OxyContin. While PBMs eventually implemented safeguards, internal emails exposed how rebates often trumped concerns about patient safety, illustrating how profit motives can compromise public health.
Breaking Down the Drug Supply Chain Security Act (DSCSA)
⚡TLDR: The Drug Supply Chain Security Act (DSCSA) mandates pharmaceutical manufacturers, wholesalers, and pharmacies to serialize and trace drugs at the package level to prevent counterfeit products. Failure to comply risks quarantining products, disrupting supply chains, and halting sales.
⚕️Pharmacy
Troubleshooting Steps Needed Now for 2025 Supply Chain Enforcement
⚡TLDR: With the FDA extending DSCSA enforcement to November 2025, health systems and pharmacies must use this time to test and troubleshoot their compliance workflows. Experts recommend running simulations for handling suspect products, ensuring Standard Operating Procedures (SOPs) work in practice, and designating a DSCSA response team for investigations. A failure to respond to inquiries within two business days can lead to regulatory action—documenting investigations thoroughly for up to six years is key to proving compliance.
LSPedia and Omnicell Collaborate for Hospitals and Health Systems
⚡TLDR: LSPedia and Omnicell are partnering to enhance DSCSA compliance for hospitals and health systems by integrating LSPedia’s OneScan® platform with Omnicell’s Central Pharmacy Manager. This solution automates serialization and traceability, streamlining workflows while mitigating risks of counterfeit drugs. Health systems using this technology gain improved operational efficiency and enhanced patient safety through end-to-end visibility.
🚚 Distributors
How Cencora supports compliance
⚡TLDR: Cencora is helping manufacturers and distributors meet DSCSA requirements by resolving data quality issues and ensuring smooth serialization processes. With over 90% of data captured but not always clean, Cencora urges trading partners to use this interim period to refine systems, correct duplicate Global Location Numbers (GLNs), and establish robust SOPs. Their advice: test, validate, and eliminate gaps now to prevent disruptions in 2025.