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Reportlinker Adds Anti-Counterfeiting Packaging Technologies in the Global Pharmaceutical and Food Industries
Date:12/14/2010

ty with International Standards 181

Coding and Identification of Drug Products in Europe 181

GS1 U.S. 2015 Readiness Program: Visibility/Traceability for Healthcare Applications—Product Recalls, Serialization, and Drug Pedigree 182

GS1 Healthcare Industry Sunrise Dates 183

GS1 Canada's Pharmacy Sector Engagement 184

Global RFID Interoperability Forum for Standards 184

U.S. DRUG PEDIGREE REQUIREMENTS: THE PRESCRIPTION DRUG MARKETING ACT 185

FDA Risk-Based Enforcement of Pedigree Requirement, 2006 to 2007 186

FDA Guidance for Industry on PDMA Requirements 186

Who Should Maintain a Written Agreement? 186

What Information About the ADR Must a Manufacturer Make Available on the List? 186

How Often Should Manufacturers Update Their ADR Lists? 187

Is Placing the ADR List on the Manufacturer's Website Adequate to Meet the Provision of Making the List Available on Request to the Public? 187

What Information Does a Manufacturer Have to Provide to a Wholesaler to Enable that Wholesaler to Comply with the PDMA? 187

What Information Does an ADR Have to Provide to a Non-ADR to Enable that Non-ADR to Comply with the PDMA (e.g., to pass a pedigree that lists all prior transactions back to the manufacturer)? 187

Are Contract Manufacturers Considered Manufacturers Under the PDMA? 188

Is a Repackager or Relabeler Exempt from Providing a Pedigree? 188

Is a Pedigree Required if an Exclusive Distribution Agreement Exists? 188

What are the Recordkeeping Requirements for Pedigree Recipients? 188

Is a Pedigree Required for the Distribution of Drug Samples? 188

Can Paper or Electronic Pedigrees be Used? 189

Is RFID the Only Way to Achieve an Electronic Pedigree? 189

State Initiatives Targeting Wholesale Distributor Licensing 189

California State Pedigree Law 190

California Law Requirements 190

Drug Pedigree 191'/>"/>

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