Trump & Sanders’ reimportation proposals a risk, AmerisourceBergen – in-Pharma Technologist

” “How a wholesaler could potentially procure drugs, whether they’re in Canada, Europe and get those back to the US and get those into the supply channel efficiently and effectively I think is quite cumbersome,” said CFO Tim Guttman. “It’s not efficient and there are risks.” VP Barbara Brungess added despite the impracticalities and legal hurdles to overturn, the primary concern is safety.”

Read the full article:  Source: Trump & Sanders’ reimportation proposals a risk, AmerisourceBergen – in-Pharma Technologist.com


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Experts warn pharma to take precautions against Thanksgiving thefts

“drug companies still need to take precautions when normal operations are disrupted Shepard said, explaining that: “Thanksgiving has the highest number of cargo thefts compared to all holidays.”

“Fridays, Saturdays and Sundays are when most cargo thefts occur and most thefts occur with parked vehicles.””

Read the full artice: Source: Experts warn pharma to take precautions against Thanksgiving thefts


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Training Certification Class for Designated Representative and Exemptee license applicants

How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’ – The Washington Post

“For 10 years, the government waged a behind-the-scenes war against pharmaceutical companies that hardly anyone knows: wholesale distributors of prescription narcotics that ship drugs from manufacturers to consumers.”

Read the full article:  Source: How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing their job’ – The Washington Post


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The Forwarder Awakens: Amazon receives NVOCC | Air Cargo World

“Many in the industry had speculated that Amazon was making the investments in logistics networking merely to avoid future delays in shipping goods during peak season, as the e-tailer had experienced before with integrator such as FedEx and UPS. But the NVOCC license suggests that Amazon is interested in becoming a permanent player in the 3PL market.”

Read the full article: Source: The Forwarder Awakens: Amazon receives NVOCC | Air Cargo World


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2015 DR 3PL Tr

 

New Draft Guidance Clarifies UDI Exceptions for Convenience Kits – FDA Law Blog

Hands holding a pen, above some papers“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


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

Prescription vial spilling out drug capsules

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


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

FDA letters on building blocks

“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 2014 policy document that: “The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.””

Read the full article: Source: FDA Releases First Wholesaler and 3PL Facility Licensure Data to the Public | The National Law Review


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NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors – Drug Channels

Graphic of different kinds of medicines

“This year’s report—our sixth edition—has been updated, revised, reorganized, and expanded. It contains the latest industry and financial data, along with detailed information about the strategies and market positions of the largest public companies: AmerisourceBergen, McKesson, and Cardinal Health. It also includes many new elements.”

Read the full article: Source: Drug Channels: NEW: 2015-16 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors


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With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers – FDA Law Blog

“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November 1, 2015.”

Gavel, law books, and a scaleRead the full article via: Source: FDA Law Blog: With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers

You might also be interested in the FDA guidance:

DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy Guidance for Industry – FDA (PDF)


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New CA Licenses Required For Third-Party Logistics Providers (3PLs)

Wood gavel on stack of red law booksThis announcement was just sent by the California Board of Pharmacy:

“Companies that do not own, but receive, store and ship prescription drugs and prescription devices into or within California need to obtain a third-party logistics provider (3PL) license immediately with the California State Board of Pharmacy.

Formerly, these entities were licensed as wholesalers or nonresident wholesalers by the Board of Pharmacy, but with passage of federal legislation in November 2013 and Assembly Bill 2605 (Bonilla) in 2014, entities that were previously licensed by the board as wholesalers need to obtain a different license as a third-party logistics provider as well as designate a responsible manager and secure licensure of specialized employees who will serve as designated representatives – 3PLs.

Wholesalers that operate as 3PLs need to work with the board to achieve compliance and become properly licensed.

To view the legislation, go to: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml

For a 3PL application, go to: http://www.pharmacy.ca.gov/applicants/index.shtml

For more information, call the Board of Pharmacy at: (916) 574-7900.”

You might also be interested in:

Link to AB-2605 Pharmacy: third-party logistics providers.(2013-2014)


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