Serialization

California BoP Modifies First Proposed E-Pedigree Regs in Response to Public Comment

During its public board meeting on December 13, the California State Board of Pharmacy discussed written and oral comments provided in response to the first proposed regulations needed to implement the state’s electronic drug pedigree provisions.

AndersonBrecon Cited For Serialization Technology

AndersonBrecon announced it has become the first company to secure two awards in the same year at this year’s European Outsourcing Awards Madrid, Spain.

Serialization Addressed At Omega Design-Hosted IoPP Meeting

Omega Design Corporation,  a global provider of packaging machinery and serialization solutions, and bottle unscrambling technology , hosted the Fall meeting of the Institute of Packaging Professionals’ (IoPP) Drug and Pharmaceutical Packaging Committee from September 23-25, 2012 at its Exton, PA facility.

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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