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Title: MedTrax Inc Highlights Urgent DSCSA Compliance Needs Ahead of FDA Enforcement

United States, 1st Jul 2025 - It was a day like any other for a mid-sized pharmacy when a notification from the FDA arrived, an official penalty for non-compliance with the Drug Supply Chain Security Act (DSCSA). The fine, though financially significant, was the least of their concerns. What followed was the suspension of their license to operate, creating chaos for both staff and customers. With the looming deadlines of DSCSA legislation, many pharmacies found themselves unprepared to meet the extensive compliance requirements.The Drug Supply Chain Security Act (DSCSA) is a critical law aimed at protecting Americans from unsafe, counterfeit, or misbranded medications by establishing a transparent, secure, and traceable drug supply chain. While the law’s intent is straightforward, the full enforcement of the DSCSA is set to take effect this November, leaving many pharmacies scrambling to meet the legal obligations.Decoding the DSCSA: Background and ObligationsEnacted in 2013, the DSCSA requires manufacturers, wholesalers, and dispensers to securely transmit and maintain electronic pedigrees (proof of origin) for all drugs in the supply chain. The goal is to ensure that all medications are traceable, from manufacturer to patient. However, the specifics of the law’s implementation have created significant challenges for many pharmacies, particularly with the upcoming deadlines for full enforcement.Pharmacies must maintain an unalterable, tamper-proof record of medication history, but many remain unaware of the complexities and potential penalties for non-compliance. As enforcement ramps up, the risks of failing to meet these standards are significant, including hefty fines, loss of licensure, and even criminal charges.Complexity Overload: Key Challenges in Pharmacy Compli...

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