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Serialization

Industry leaders praise Senate passage of H.R. 3204 bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
News
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GS1, UPS hail Senate passage of H.R. 3204

Industry leaders praise bill with enhanced track-and-trace initiatives for the pharmaceutical supply chain.
E-BOOK SPECIAL REPORT
42 Best Package Designs
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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.
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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.
What does the recently ended government shutdown mean for the healthcare community?
Column/Opinion
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The healthcare community and the government shutdown

What’s the impact from the just-ended shutdown for makers of pharmaceuticals, biologics, and medical devices? Give us your opinion.
TRAXSECURE UNALTERED. The TraxSecur™ security feature is printed, without a requirement for any special inks, as a background that looks similar to those seen on security paper, except that it is created as a unique “instance” relating to a single time and place, which inextricably links an individual package to its unique corresponding track-and-trace information; this is Serialized Security™.
Feature Article
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Update on serialization and unique device identification regulatory developments

Key regulatory developments could preempt California e-pedigree and provide clarity for manufacturers and packagers of pharmaceuticals, biologics, and medical devices.
When implementing serialization, it’s important to consider handling partial containers.
Column/Opinion
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Serialization readiness: What about my partial containers?

When implementing serialization, it’s important to consider handling partial containers.
The U.S. House passed a track-and-trace and compounding bill.
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U.S. House passes track-and-trace bill

H.R. 3204 now awaits Senate approval. If passed into law, the new bicameral bill would preempt California e-pedigree and give industry more time to comply.
Track and trace/serialization for bottles
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Track and trace/serialization for bottles

Marchesini Group's NERI RE202 1T 1C automatic rotary labeling machine applies self-adhesive or glued labels; can be equipped with one to two label dispensing heads. Designed to position and label oval, shaped, or cylindrical containers.
Fully integrated turnkey serialization retrofit for existing packaging line
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Fully integrated turnkey serialization retrofit for existing packaging line

Acsis' Serialization in a Box solution allows for management of serialized and non-serialized product simultaneously through the bundle to the case and all the way out through packaging and distribution.
UPS survey shows supply chain issues in North America.
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UPS survey finds global healthcare executives driving supply chain transformation to reach new markets

Investments planned in areas such as technology amid growing concerns over product protection, global regulatory environment.
Figure 1. Manufacturer A is probably acting as a contract manufacturer/packager on behalf of the NDA holder, manufacturer B.
Column/Opinion
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Working with CMOs under California e-pedigree

For different products, manufacturers may fill the role of an exclusive distributor, a contract manufacturing organization, or a repackager. Each of these would be treated differently under the California law with respect to pedigree origination and updating.

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