Learn about the DSCSA pilot project program.Browse answers to questions on product tracing requirements.Find more information through webinars on various requirements.Get involved with DSCSA issues through FDA’s public meetings.Read the law Drug Supply Chain Security Act.Verify Wholesale Drug Distributor Licenses.August 18, Updated: Notify FDA of Illegitimate Products.September 20, Updated: Product Tracing Requirements Frequently Asked Questions.September 23, Immediate-in-Effect Guidance Announced: Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry.December 7-8, Public Meeting (Virtual): The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023.consumers.Īdditionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers, and requires these entities report licensure and other information to FDA annually. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. This will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Sign up for email updates on the Drug Supply Chain Security Act. The law requires wholesale distributors and third-party logistics providers to report licensure and other information annually to FDA.
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