The definition of a “pedigree” varies state by state. Under the Prescription Drug Marketing Act (PDMA), the law that established the standards for prescription drug distributor licenses, those distributors who are not authorized by the manufacturer to handle and sell their products must pass on an “identifying statement” to those who are the purchasers.
That statement identifies each prior sale, purchase or trade of the prescription drug. It is important to know that although the identifying statement and pedigree have become synonymous, the federal guidance and regulations implementing the official PDMA never use the word “pedigree.”
Each state is required to follow PDMA as a “baseline,” but can enact additional regulation or legislation as it sees fit. Some states have legally listed specific requirements for “pedigree,” but current definitions and the documentation required in order to meet the pedigree compliance standards are not uniform.
Some states have outlined specific paper-based requirements, while other states plan to implement electronic track-and-trace solutions that can further address security issues with modern technology.
HDMA is committed to achieving uniform pedigree requirements across the country that promote a safe and secure supply chain while maintaining effective and efficient distribution of prescription drugs.
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News
- HDMA Applauds Passage of Federal Traceability Legislation by House Energy and Commerce Committee -
May 15, 2013
- “Track-and-Trace Law Moves Forward in Congress” - Pharmaceutical & Medical Packaging News, May 6, 2013
- “Debate Heats Up Over U.S. Prescription Drug Tracking” - Reuters, April 25, 2013
- HDMA Statement on Federal Pharmaceutical Traceability Legislation -
April 25, 2013
- “Four Senators Push Bill to Improve Medicine Tracking in Pharmaceutical Supply Chain” – Philadelphia Inquirer, April 22, 2013
- “Industry Ready to Resurrect Track and Trace Negotiations” - FiercePharma Manufacturing, April 4, 2013
- “Safe Solution for Rx Supply Chain” - Politico, April 2, 2013
- “Pharmaceutical Distribution Security Alliance Applauds IOM Call for National Supply Chain Solution” - PDSA Press Release/BusinessWire, February 14, 2013
- HDMA's Elizabeth Gallenagh, Esq., Participates in On-Demand Video: "Regulations, Recalls, and Responsiveness: The Three R's of Traceability" - Consumer Goods Technology, July 17, 2012
- Ventimiglia: Protect Patients by Strengthening Supply Chain - Roll Call Opinion, May 7, 2012
- HDMA CEO Perspective: A Look Ahead to 2012 Priorities - January 17, 2012
- HDMA’s John M. Gray Highlights 2012 Industry Priorities in Jan. 2 Issue of Chain Drug Review - January 2, 2012
Testimony
Regulatory - Federal
Regulatory – State
Technical/Standards
Education
- 2012 Distribution Management Conference - March 13, 2012
Research
The Center for Healthcare Supply Chain Research
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Issue Contact: Liz Gallenagh (Government Affairs), Anita Ducca (Federal Regulatory Affairs), Kristen Freitas (Federal Affairs), Dan Bellingham (State Affairs), Perry Fri (Industry Relations), John Howells (Industry Relations) |
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