DSCSA Serialization Mandates Take Effect, Transforming U.S. Drug Supply Chain Security

The DSCSA serialization mandates have gone into effect in November 2023, transforming the U.S. drug supply chain's security. Stakeholders face challenges in implementing the new requirements, including unit-level serialization and documentation. Non-compliance carries severe penalties. The industry is working to upgrade technology and processes to meet the deadline. Patient safety and drug integrity are at stake in this critical period of adjustment.

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DSCSA Serialization Mandates FAQs

Frequently Asked Questions (FAQs) - DSCSA Serialization Mandates

Q1: What are the DSCSA Serialization Mandates?

A1: The DSCSA Serialization Mandates require that all levels of the pharmaceutical supply chain, including manufacturers, repackagers, wholesale distributors, and dispensaries, implement systems to electronically trace prescription drugs as they move through the supply chain. This involves assigning a unique serial number to each package and case of medication.

Q2: When did the DSCSA Serialization Mandates take effect?

A2: Elements of the DSCSA Serialization Mandates have been phased in over several years, starting from the enactment of the DSCSA in 2013. The full serialization requirements are expected to be implemented by 2023.

Q3: Why were the DSCSA Serialization Mandates introduced?

A3: The mandates were established to enhance supply chain security for pharmaceuticals in the United States by enabling more precise tracking and tracing of prescription drugs to combat the proliferation of counterfeit, stolen, contaminated, or otherwise harmful drugs.

Q4: How are companies expected to serialize drug packages?

A4: Companies are expected to serialize drug packages using a unique identifier, such as an alphanumeric serial number, and to ensure that this information is captured in a 2D data matrix barcode on the drug packaging.

Q5: What are the consequences of noncompliance with the DSCSA Serialization Mandates?

A5: Noncompliance with the DSCSA can result in various regulatory actions by the FDA, including fines, recalls, or even criminal charges in cases of intentional violation.

Q6: How will the Serialization Mandates impact the pharmaceutical supply chain?

A6: The mandates are expected to transform the pharmaceutical supply chain by improving transparency and accountability, helping stakeholders quickly identify and respond to issues with drugs, reduce counterfeit drugs, and facilitate more effective recalls if necessary.