Serialization

California Staggering Its E-Pedigree Regulations

As the California State Board of Pharmacy (CA BoP) begins initiating the adoption of regulations to implement the state’s electronic drug pedigree law, recent cases of fraud and diversion are coming to light, perhaps offering renewed justification for the law.

In July, dozens of people were charged in New York City for diverting and trafficking prescription drugs for treating HIV that were paid for by Medicaid, in some cases twice. Diverters reportedly purchased prescribed drugs from Medicaid beneficiaries, removed patient labeling from bottles, and added counterfeit labels as needed to redistribute the drugs back in the supply chain. According to a press release issued by the U.S.

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California Needs Stakeholder Input in Order to Permit Inference

With several drug manufacturers already employing 2-D bar coding as they prepare to meet California’s electronic pedigree rule, inference will be key to achieving both supply-chain efficiency and regulatory compliance.

Inference refers to inferring “the contents of a case, pallet, or other aggregate of individual units, packages, or containers of dangerous drugs, from a unique identifier associated with the case, pallet, or other aggregate, without opening each case, pallet, or other aggregate or otherwise individually validating each unit,” according to the California State Board of Pharmacy (CA BoP).

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Health Systems Group Seeks GS1 Standards

Speakers at GS1 Connect in June shared several business reasons to standardize product identification. Health systems representatives spoke of efficiencies that standardized identification could bring in product and patient identification and tracking as well as improvements in billing, ordering, and inventory. Many spoke of the need for standards, such as the GS1 family of standards.

Seidenader to Showcase Inspection and Serialization Capabilities at ACHEMA

At ACHEMA 2012, Seidenader Maschinenbau GmbH will showcase a new inspection station that measures and evaluates stress birefringence in containers, which can help identify specific prestages of crack formation, the company reports. The station will be integrated into a Seidenader MS inspection machine for vials with a throughput of up to 24,000 containers/hour. Another system will be shown for inspecting up to 36,000 syringes per hour for particles or cosmetic defects. Feeding and orientation of the syringes is provided by a Seidenader SyWalker.

GS1 Healthcare US Names New Leader

GS1 US has appointed Siobhan O’Bara as vice president, healthcare. O’Bara is now responsible for setting strategy and ensuring achievement of operating results for GS1 Healthcare US, including supporting GS1 Standards implementation initiatives
across the U.S. healthcare industry, the standards organization reported in a press release. 

Mettler-Toledo Hi-Speed Adds Serialization Sales Expert

Janice Wortham has joined Mettler-Toledo Hi-Speed as Regional Sales Manager for Pharmaceutical Sales, bringing more than 12 years of experience in packaging machinery sales. Working in the past with Waukesha Cherry-Burrell and Cozzoli Machine Co., Wortham has focused since 2004 on serialization, track and trace, and vision inspection solutions sales for the pharmaceutical industry, working with Systech International and Seidenader Vision.

India Plans For Bar Codes

The country looks to protect its brands with a requirement for serialized coding on exported packaging.
Although Indian government deadlines were recently deferred for meeting a bar coding mandate, drug manufacturers in the country still have only months to implement serialization solutions.
“Because the regulation just came out in June, companies have been in a mad rush to evaluate technology and make a decision.
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Combating Counterfeits

The pharma industry is working toward establishing the ideal anticounterfeiting system, combining authentication tools and track-and-trace capabilities to serialize at the unit level, for every drug.

By Marie Redding
Freelance Writer

It’s increasingly difficult—even for the experts—to tell the difference between a counterfeit drug and the real thing. Consumers feel they have no sure way of knowing if they’re getting duped. They may even ingest a harmful ingredient a counterfeiter has used to make a fake pill—like highway paint, floor wax, and boric acid—according to a CBS news report.

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New Virtual Conference Focused on Track & Trace Solutions for the Pharma Sector

Now in our archives is our exclusive virtual conference event that examines one of the key issues facing the Pharma and BioPharma supply chain, counterfeit drugs. Titled ‘Pharmaceutical Track & Trace and Authentication: The Fight against Fake Drugs’, the event is presented by UBM brands Pharmaceutical & Medical Packaging News, Tracking & Tracing Pharmaceutical Products, InnoPack, and Pharmapack in association with CPhI Conferences. The online format features two supplier webinars, two “exhibition halls” and a lineup of featured speakers.

Standing Together to Meet Global Serialization Rules

Three companies unite to provide a powerful stand-alone platform.

A new system launched in Brazil at FCE Pharma is designed to offer a stand-alone solution to support different approaches to pharmaceutical product serialization. VisioCIT can handle either labeling or direct coding, reports Christoph Lehmann, director of Uhlmann VisioTec GmbH (www.visiotecamerica.com), which can position companies to meet Brazil’s pending rules as well as others around the world.

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