Become familiar with the law There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for […]
Tag: Supply chain
Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce
“HDMA’s 2014-15 Factbook updates member financial, operational performance. The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was […]
FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference
“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect. Dr. Connie Jung, Acting Associate Director for Policy and Communications for […]
FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com
“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines. The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment […]
FDA Says > Know Your Source: Protecting Patients from Unsafe Drugs
“Beware of Rogue Wholesale Drug Distributors Wholesale drug distributors are a link between manufacturers and health care professionals. Their role is to ensure prescription medications are delivered safely and efficiently to thousands of health care practitioners and pharmacies nationwide every day. While the U.S. health care supply chain is one of the most secure and […]
HDMA – Issues in Distribution: Pharmaceutical Traceability and the Drug Supply Chain Security Act
“The Drug Supply Chain Security Act (DSCSA, or Title II of the Drug Quality and Security Act) was enacted on November 27, 2013. The act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. The law will transform how the domestic supply […]