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 […]
Tag: training
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 […]
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 […]
Industry groups take issue with guidance on outsourcing facilities
“GPhA says compounders and outsourcing facilities should abide by the same inspection criteria as other drug manufacturers. “Drug manufacturers with U.S-based facilities are required to be inspected by FDA at least every 24 months,” GPhA says. “Compounders producing sterile products should be held to similar standards.” Similarly, BIO disagrees with FDA’s proposed alternative approaches for […]
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 […]