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 […]

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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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NASP and SPAARx merge to create unified specialty pharmacy association – DrugStoreNews

“The National Association of Specialty Pharmacy and the Specialty Pharmacy Association of America  announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy. “This is a historic moment in our industry — one in which our two organizations come together, recognizing the unique […]

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Federal government renews charges of illicit drug distribution involving FedEx – Pharmaceutical Commerce

“It has been the contention of DEA and the Dept. of Justice for several years that companies involved in shipping and delivering controlled substances must ensure that both providers and shipment recipients are authorized (licensed) to make or receive these shipments. In “normal” distribution, a licensed manufacturer of such drugs ships them to a licensed […]

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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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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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