Pharmaceutical Work Group
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The Pharma Work Group was formed to assist with the implementation of auto ID in regulated environments such as the drug supply chain. The work group is comprised of veterans of the industry, each with several decades of experience. Some of the committee members have been involved in the auto ID industry since its infancy; all are current practitioners in one aspect or the other.
The work group constructed a news release on Asset Tracking Technologies Solving COVID-19 Vaccine Challenges accompanied with the Digital Supply Chain Whitepaper to assist organizations in understanding how AIDC technologies and standards are being used to ensure traceability for all pharmaceuticals especially during COVID times. |
Goals
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About the Drug Chain Security Act
The Drug Quality and Security Act (DQSA) was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DQSCA), outlines the steps to build an electronic system to identify and trace prescription drugs. This includes both prescription pharmaceuticals and biologicals (such as blood and parenteral drugs) distributed in the United States. These are collectively called drugs here. The DQSCA goals are to:
The FDA is developing a schedule for implementing the law’s requirements. Among key provisions implemented over the next 10 years are requirements for:
As the first of several guidances and regulations that the FDA plans to issue and implement, the “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification (SNI) for Prescription Drug Packages” document indicates standards that must be developed for identification, validation, authentication, and tracking and tracing of prescription drugs. In this document, the FDA recommends specifically that the SNI for most prescription pharmaceutical packages should be a serialized National Drug Code (sNDC) corresponding to the specific drug product NDC combined with a unique serial number, generated by the manufacturer or repackager for each individual unit of sale package and applied to each new package in both human-readable and machine-readable forms.
The Drug Quality and Security Act (DQSA) was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DQSCA), outlines the steps to build an electronic system to identify and trace prescription drugs. This includes both prescription pharmaceuticals and biologicals (such as blood and parenteral drugs) distributed in the United States. These are collectively called drugs here. The DQSCA goals are to:
- Enable verification of the legitimacy of the drug Product Identifier down to the unit of sale package level
- Enhance detection and of suspect or counterfeit products in the drug supply chain and provide a formal notification system
- Improve the efficiency of drug recalls of drug products
The FDA is developing a schedule for implementing the law’s requirements. Among key provisions implemented over the next 10 years are requirements for:
- Product identification. Drug manufacturers and repackagers are to put a unique Product Identifier on prescription drug packages, using AIDC (ex: a serialized bar code using SNI, see description below)
- Product tracing. Drug manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain are to track the chain of custody of drugs sold in the U.S.
- Product verification. Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) are to establish systems and processes to be able to verify the serialized Product Identifier on unit of sale prescription drug packages.
- Detection and notification. Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) are to quarantine and identify drugs that are suspect.(counterfeit, unapproved, or potentially dangerous) and to notify FDA and other stakeholders
As the first of several guidances and regulations that the FDA plans to issue and implement, the “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification (SNI) for Prescription Drug Packages” document indicates standards that must be developed for identification, validation, authentication, and tracking and tracing of prescription drugs. In this document, the FDA recommends specifically that the SNI for most prescription pharmaceutical packages should be a serialized National Drug Code (sNDC) corresponding to the specific drug product NDC combined with a unique serial number, generated by the manufacturer or repackager for each individual unit of sale package and applied to each new package in both human-readable and machine-readable forms.