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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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) […]

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The Differences Between The DSCSA, FDA Rules and Guidance – RxTrace

How To Approach, Read, and Interpret the DSCSA Another great educational snippet from Dirk Rodgers (RxTrace). Follow the link below to read his full article. “So let’s apply that to the exchange of Transaction Information TI, Transaction History TI, and Transaction Statements TS that all U.S. pharma supply chain trading partners must do beginning on […]

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FDA DSCSA Workshop – Meeting Materials

Follow the link below to the FDA webpage of all related meeting materials and notices: “[This FDA public workshop, May 8-9, 2014, was] intended to gather information, current practices, research and ideas on the standards for the exchange of transaction information, transaction history and transaction statements, in paper or electronic format, for each transfer of […]

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Apply for a Designated Representative License – CA Board of Pharmacy

Follow the link below to find and download the application form that you need, including Designated Representative, and Wholesaler applications: “Apply for a License – Please select the license type you wish to apply for to download the application and instructions.” – via CA Board of Pharmacy – Apply for a License. Go to DREprof.com: The […]

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