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Securing America’s Pharmaceutical Supply Chain Act
12/30/2022, 5:32 PM
Summary of Bill HR 3683
The main purpose of this legislation is to prevent counterfeit or substandard drugs from entering the US market by implementing stricter regulations and oversight measures. The bill requires pharmaceutical manufacturers, distributors, and other entities involved in the supply chain to establish and maintain systems for tracking and tracing prescription drugs.
Additionally, the Securing America's Pharmaceutical Supply Chain Act mandates the use of serialization technology to ensure the authenticity of prescription drugs throughout the supply chain. This technology allows for the unique identification and tracking of individual drug packages, making it easier to detect and prevent the distribution of counterfeit drugs. Furthermore, the bill requires the establishment of a national database to track and verify the authenticity of prescription drugs. This database will be accessible to authorized stakeholders, including regulators, law enforcement agencies, and healthcare providers, to help ensure the safety and integrity of the pharmaceutical supply chain. Overall, the Securing America's Pharmaceutical Supply Chain Act aims to protect consumers from the risks associated with counterfeit drugs and strengthen the security of the US pharmaceutical supply chain. The bill is currently being reviewed by Congress and may undergo further revisions before being enacted into law.
Congressional Summary of HR 3683
Securing America's Pharmaceutical Supply Chain Act
This bill allows an executive agency to purchase a drug approved or licensed by the Food and Drug Administration only if the drug is over 50% sourced, manufactured, and assembled in the United States.
This requirement may be waived (1) if the drug is not available in sufficient quantity or quality as over 50% sourced, manufactured, and assembled in the United States; or (2) during an emergency.
The U.S. Trade Representative (USTR) shall modify U.S. product coverage under all free trade agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of essential medicines and medical countermeasures. Subsequent to such modifications, the USTR shall make any necessary corresponding modifications of existing waivers and notify the Office of Management and Budget.
