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Serialization & Track-and-Trace: Page 61

Adherence/Delivery
Your Top 10 Healthcare Packaging stories from 2013
Serialization stories dominated the list among Healthcare Packaging online readers, but the top-read story of the year revealed some dirty deeds.
December 19, 2013
Author Katherine Eban’s (shown here) book “Dangerous Doses,” exposed the dark side of America’s pharmaceutical trade. Here, the investigative journalist looked at the epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans.
Materials
Global compliance: Flexibility is the key
To accomplish the successful deployment of a global serialization program, flexibility is the key.
December 19, 2013
Materials
GS1 standards involved in serialization
With so many players in the supply chain poised to exchange data, it’s important that the industry coalesce around a common set of standards to ensure interoperability and scalability of integrations.
December 18, 2013
Pharmaceuticals
Serial number management, certifications, and pedigree reporting
Serial number management is a set of functions that will allow you to securely and accurately control and keep track of the serial numbers you apply to your pharmaceutical or biologic products.
December 16, 2013
Pharmaceuticals
The business case for serialization
While the e-pedigree regulations in Turkey and California may have been your catalyst for serialization, completed projects reveal a wealth of business benefits—some anticipated, some surprises!
December 15, 2013
Pharmaceuticals
DQSA would replace the patchwork
In the fall of 2013, the U.S. House of Representatives passed the Drug Quality and Security Act (DQSA), a bill that would regulate compounding pharmacies and would impose a phased-in nationwide serialization and e-pedigree regulation.
December 14, 2013
Pharmaceuticals
Not just ‘why,’ but ‘how’
Miracles still happen. In the fall of 2013, the U.S. House of Representatives and Senate passed the Drug Quality and Security Act (DQSA), a bill that will regulate compounding pharmacies and would impose a phased-in nationwide serialization and e-pedigree regulation.
December 11, 2013
Pharmaceuticals
Pharmapack Europe 2014 focuses on innovation
Feb. 12-13 event, now at the Porte de Versailles, will concentrate on packaging and delivery systems for medications and healthcare products.
December 10, 2013
Pharmapack Europe 2014, will be held Feb. 12-13 at the Porte de Versailles, will concentrate on packaging and delivery systems for medications and healthcare products.
Pharmaceuticals
H.R. 3204 bill signed into law
Establishes national track-and-trace/serialization system and brings more federal oversight to large-volume compounding pharmacies that custom-mix medications in bulk.
December 2, 2013
President Obama recently signed into law H.R. 3204, which establishes national track-and-trace/serialization system and brings more federal oversight to large-volume compounding pharmacies that custom-mix medications in bulk.
Pharmaceuticals
GS1, UPS hail Senate passage of H.R. 3204
Industry leaders praise bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
November 19, 2013
Industry leaders praise Senate passage of H.R. 3204 bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
Traceability/Serialization
Drug Quality and Security Act passes Senate
U.S. Senate passes H.R. 3204 and sends it to President Obama. Bill would preempt all current serialization and pedigree laws, have impact on compounding.
November 18, 2013
U.S. Senate passes H.R. 3204 and sends it to President Obama. Bill would preempt all current serialization and pedigree laws, have impact on compounding.
Pharmaceuticals
UDI and the approaching end of the NDC
FDA’s definition of UDI and its mandate should bring the same benefits to medical devices over the coming years that the National Drug Code has to standardization in its market.
November 8, 2013
Dirk Rodgers
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Page 61 of 68
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Top Stories
Under the TIA/MWF petition, a single QR code could stand in for the printed compliance leaflets that ship with smartphones today, linking to a regulatory page manufacturers could update after products reach store shelves. For phones, the device itself provides an offline backup. OTC and pharma brands considering the same swap for package inserts have no such fallback.
Labeling/Printing
Telecom Asks FCC to Let On-pack 2D Codes Replace Printed Regs
Telecom groups want the FCC to let a QR code replace printed regulatory text on device cartons, an idea the agency shelved in 2017. The questions it raises, from code standards to the 1 in 11 U.S. adults without a smartphone, may inform or shape how OTC, pharma, and CPG brands move leaflets and on-pack text online.
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How Demand for Contract Manufacturing is Driving the Pharmaceutical Manufacturing Market Forecast
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Consumers Want Sustainable Health Packaging, but Not at the Expense of Quality
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Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
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Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
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