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 […]

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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 […]

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Free Tips – Florida Designated Representative (CDR) Exam Prep

Florida Certified Designated Representative – CDR Exam Prep Course Simply studying for the Florida Certified Designated Representative (CDR) examination isn’t enough! Many candidates only study the exam subjects and content, then take what’s considered a difficult exam. Some of these same candidates don’t pass the exam. As you prepare for the examination, you have to […]

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Florida Certified Designated Representative (CDR) Exam Prep

California Designated Representative Training Courses (approved by the California State Board of Pharmacy) – Available around-the-clock 24 x 7 Florida Certified Designated Representative CDR Exam Prep Course The Designated Representative Institute Updated April 10, 2018 The Florida DBPR website has been redesigned.  Here’s how to get the most current version of the Florida CDR Candidate Information […]

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CA Home Medical Device Retailer (HMDR) FAQs

“The Home Medical Device Retailer (HMDR) licensing program is administered as part of the Medical Device Safety Section and is governed by law found in the California Sherman Food, Drug and Cosmetic Law.  The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. …  Also found below is a link to […]

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FDA Law Blog: And So It Begins: FDA Issues First DSCSA Guidance

The FDA just published:  Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF) William Koustas (FDA Law Blog) writes, “The DSCSA tasked FDA with addressing three issues in this guidance: (1) identifying scenarios that could increase the risk of suspect product entering the supply chain; (2) recommending […]

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