FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com

FDA Logo in blue“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 until December 8.”

Read the full article: via SecuringIndustry.com – FDA publishes Q&A on DSCSA provisions.

View the FDA’s draft guidance: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers – FDA Draft Guidance For Industry (PDF)


Go to DREprof.com: The Designated Representative and Exemptee Training Website

 

Wishful Thinking?! Both Work Experience AND Training Are Required

eLearning - Online TrainingThis 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 a training program that addresses key subjects/topics).

Work experience does not substitute for the training program, and the training program does not substitute for work experience.

References:

  1. Application For Home Medical Device Retailer Exemptee License – New And Renewal (CDPH Food & Drug Branch) – PDF  
  2. Designated Representative Requirements And Application (CA State Board of Pharmacy) – PDF

Go to DREprof.com: The Designated Representative and Exemptee Training Website