July 12, 2024
FDA Announces Small Dispenser Exemption
On July 12th, 2024, the FDA announced an exemption for small dispensers from the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. However, the FDA will not extend further enforcement discretion for other parts of the supply chain. Trading partners who are not prepared […]
March 8, 2024
How Ozempic Counterfeits Demonstrate the Urgent Need for a Secure Supply Chain
When demands soars for prescription pharmaceuticals and supply falls short, drug pirates get to work. The bad actors manufacture and package fake drugs to look just like the legitimate brand-name medication. And many times, these counterfeits make their way into legitimate supply chains. Counterfeit versions of Novo Nordisk’s diabetes drug Ozempic pose severe risks to […]
January 12, 2024
FDA Allows Florida to Import Prescription Drugs from Canada to Alleviate High Prices
Florida marks a milestone as the FDA authorizes the state to import prescription drugs from Canada to alleviate high drug prices. This decision, resulting from bipartisan discussions and executive orders, grants Florida a two-year period to implement its drug importation program, potentially saving the state up to $183 million in the first year. However, obstacles […]
January 11, 2024
The Importance of Anti-Counterfeiting Solutions
Published January 11th, 2024 The global pharmaceutical industry faces a significant challenge with counterfeit medicines, estimated to be one in 10 medical products in low- and middle-income countries, leading to a $30.5 billion spending on substandard drugs. Counterfeit medicines, often indistinguishable from genuine ones, pose severe risks, including toxic ingredients that can be life-threatening. The […]
August 28, 2023
FDA: Additional Time to Refine Systems and Processes for Interoperable Electronic Tracing
Effective August 25, 2023: FDA issues new compliance policies to help supply chain stakeholders attain enhanced traceability under DSCSA. FDA recognizes that additional time beyond November 27, 2023 is necessary to “stabilize and be fully interoperable for accurate, secure, and timely electronic data exchange.” FDA is issuing this compliance policy to provide additional time, beyond […]
