“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 […]
Tag: CDR
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 […]
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 […]
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 […]
Your Florida CDR just quit. What do you do?
“My company is a prescription drug wholesale distributor (in-state or out-of-state). Our Certified Designated Representative (CDR) just quit. What do we do? Notify the department within 10 business days from the CDR’s separation. Your company may continue to distribute prescription drugs in or into Florida during that 10-business day-period. After that period expires, however, your company must either (a) […]