BioCare today released a white paper on the Drug Supply Chain Security Act (DSCSA) and how companies can prepare for compliance with the U.S. Food and Drug Administration’s (FDA) requirements to ensure all medications are genuine, uncontaminated, and uncompromised. The DSCSA final phase includes the enforcement of exchanging serialized data at the package level and kicks in on November 27, 2024.
“In the world of healthcare, BioCare understands that the rules and regulations set forth to protect the pharmaceutical supply chain and ultimately the patients are not just mere guidelines but critical safeguards for their well-being,” said Peggy Yena, Vice President of Quality & Regulatory Affairs at BioCare. “Our commitment to our customers includes guiding them through the complex landscape of federal regulations at every level of operations, allowing them to focus on the safety and care of those who depend on us.”
As the intermediary between pharmaceutical manufacturers and healthcare providers, BioCare plays a vital role to ensuring the integrity and safety of the pharmaceutical supply chain. Their internal DSCSA team of IT, Quality, and Regulatory has spent the last several years educating themselves on the new regulations in order to provide its partners with all the necessary regulatory, compliance, and technical insight they need. This includes offering practical advice on serialization, tracing, and verification processes, as well as facilitating communication with regulatory agencies.
Comprised of BioCareSD and LogiCare3PL, BioCare has delivered therapies to patients with ultra-rare, rare, and orphan diseases for the last four decades through trusted partnerships with manufacturers and healthcare providers. By acting as a knowledgeable and supportive bridge between the manufacturers and customer healthcare entities, BioCare effectively enhances compliance and contributes to the overall safety and trustworthiness of the pharmaceutical supply chain.
BioCare’s white paper addresses the history of DSCSA, its goals, requirements, and the necessary steps and approaches for companies of all sizes including manufacturers and site locations to move towards compliance. A copy of the BioCare white paper, “The Drug Supply Chain Security Act (DSCSA) & How Companies Can Prepare for Compliance, is available here.