New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

“On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule.” Read the full article: Source: FDA Law Blog: New Draft Guidance Clarifies UDI Exceptions for Convenience Kits Go […]

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Prescription drug scheme: Miami Beach prescription drug supplier pleads guilty – South Florida Business Journal

“Prescription drug diversion compromises the integrity of America’s drug supply chain,” Principal Deputy Assistant Attorney General Benjamin Mizer said in a new release. “This Miami-based supplier sold tens of millions of dollars of illegally diverted drugs, which ended up on the shelves of pharmacies and in the medicine cabinets of American consumers.” Read the full […]

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FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review

“Users either can query the database when searching for a particular company here or download the entire data set as an Excel file from this page.  Although technically the law only requires a public wholesale distributor database, FDA determined that making the 3PL information public as well served the law’s goals, and it stated in a December […]

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3PL Acquisitions Expected to Increase – Pharmaceutical Processing

“They attributed the increase to growing pressure to expand services, increase geographic footprints and drive scale in specific markets. Consolidating firms will need to weather significant industry restructuring and navigate brand confusion in some markets, the report said. This year, meanwhile, respondents expected those large 2014 deals to lead to defensive acquisitions by other firms.” […]

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License Search for California Designated Representative-3PL

California Designated Representative Training for 3PL (third-party logistics providers) – Approved by the California State Board of Pharmacy The California Board of Pharmacy has enabled a license verification web page to: “License Search for California Designated Representative-3PL“ Source: California Board of Pharmacy License Search Go to DREprof.com: The Designated Representative and Exemptee Training Website California Designated […]

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Do Not Let Your Firm be the Headline for a Supply Chain Systems Failure | Supply Chain Matters

California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) – Approved by the California State Board of Pharmacy “Many years ago, I worked for a very insightful CIO who mastered communications to senior executive management. Often, when he received pressure regarding systems maintenance budgets associated with mission critical business systems such as order fulfillment, he […]

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