US Drug Ingredients Supply Chain Study

The Commerce Department’s Bureau of Industry and Security and the Department of Health and Human Services’ Administration for Strategic Preparedness and Response announced Tuesday that they are conducting a comprehensive assessment of the US Active Pharmaceutical Ingredient industrial base to gain an understanding of the supply chain network.

The resulting information will allow the federal government to more accurately plan and develop funding strategies to help ensure the availability and security of the API supply chain and to raise awareness of current limited domestic manufacturing capabilities, among other potential issues, according to BIS.

In support of the assessment, BIS will survey hundreds of US API manufacturers, distributors, suppliers and customers using the BIS’s survey collection authority under section 705 of the Defense Production Act of 1950, as amended. BIS will deploy the API Industrial Base Survey to industry in winter 2024.

“Ensuring the health and competitiveness of the API industry is vital to U.S. public health security,” Assistant Secretary of Commerce for Export Administration Thea Rozman Kendler commented. “When completed, the API assessment will provide the US government with valuable insights needed to safeguard the supply of essential medicines upon which millions of Americans depend.”

The joint effort will identify interdependencies between respondents, suppliers, customers and US government agencies while also benchmarking performance across multiple tiers of the API industry.
“The United States needs resilient, diverse, and secure supply chains to ensure our economic prosperity and national security. Using this authority to survey the API industry will allow us to better understand this critical facet of our medical critical infrastructure,” according to the release.

[BIS Release]