Issue link: https://www.e-digitaleditions.com/i/977310
12 May 2018 Tablets & Capsules T To minimize potential disruptions to the US prescrip- tion drug supply, the FDA announced last summer that it would delay DSCSA enforcement until November 2018 [1]. On March 12, the European Medicines Verification Organization (EMVO), which operates the European hub, where pharmaceutical companies must report serialization data under the FMD, announced that 500 of the approxi- mately 2,500 pharmaceutical companies in the EU had begun the onboarding process [2]. While encouraged by the milestone, the EMVO noted in the announcement that the onboarding figures were "still far behind schedule." Recently, Tablets & Capsules spoke with several indus- try professionals about how well-prepared pharmaceuti- cal companies and CMOs are to comply with DSCSA and FMD serialization requirements. Serialization remains a major topic in pharmaceutical packag- ing. In this article, we discuss the industry's readiness for the new and upcoming serialization regulations in the US and Europe. he US Drug Supply Chain Security Act (DSCSA) offi- cially went into effect last November, and the European Union's Falsified Medicines Directive (FMD) goes into effect in February 2019. While these regulations will help to ensure the integrity of drug products sold in their respective markets, preparing to comply with the laws has been a challenge for pharmaceutical companies and contract manufacturers and packagers. Serialization ready? Nate Todd Editor packaging