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: designated representative
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 […]
It’s Holiday Season. Complete Designated Rep & Exemptee Training Before Year End!
The holidays are coming! Don’t let your Exemptee training or Designated Representative training hang over your head going into November and December. Just get it done now, before: the kids get out of school you find yourself cooking in the kitchen shopping for the holidays Go to DREprof.com: The Designated Representative and Exemptee Training Website CA […]
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 […]
Wishful Thinking?! Both Work Experience AND Training Are Required
This topic is coming up a lot lately. There appears to be confusion about whether work experience satisfies the training program requirement, or vice versa. In a nutshell, if you are applying for a California Designated Representative or Exemptee License, you’ll have to meet both the work experience requirement, and the training program requirement (i.e., completing […]