WASHINGTON, D.C. — The federal government is examining U.S. production capacity and foreign sourcing dependencies for chemicals used to manufacture medicines, an assessment intended to identify supply chain vulnerabilities and guide future investments in domestic pharmaceutical manufacturing, according to the Department of Health and Human Services.
The Administration for Strategic Preparedness and Response (ASPR) is conducting the review with the Commerce Department’s Bureau of Industry and Security (BIS) and the Department of War’s Office of the Assistant Secretary of War for Health Affairs.
The assessment targets key starting materials, or KSMs, the chemical precursors and intermediates used to manufacture active pharmaceutical ingredients. Those ingredients provide medicines with their therapeutic effects.
Federal officials are seeking to determine where domestic manufacturing capacity is insufficient and where reliance on foreign suppliers or individual sources could threaten the availability of essential medicines.
BIS will conduct a one-time survey of U.S. pharmaceutical manufacturers, chemical suppliers, distributors, purchasers and customers under Section 705 of the Defense Production Act of 1950.
The survey will examine production capabilities, sourcing practices, customer relationships, supply chain disruptions, workforce conditions and research and development.
The findings will inform federal funding strategies and recommendations for strengthening domestic production and pharmaceutical supply chain security.
“A clearer picture of the KSM industrial base will help us identify gaps in manufacturing capacity and dependencies that could disrupt the production of essential medicines,” Arlene Joyner, deputy assistant secretary of ASPR’s Center of Industrial Base Management and Supply Chain, explained.
The assessment extends a previous BIS survey of the active pharmaceutical ingredient industrial base, conducted with ASPR and completed earlier in 2026.
That review examined pharmaceutical manufacturers’ production capabilities, sourcing and supply chain disruptions. The new effort moves further upstream to evaluate the chemical materials and suppliers on which those manufacturers depend.
The agencies plan to compile their findings into a report assessing domestic production capacity, supply chain vulnerabilities and the industry’s ability to respond to public health emergencies.
“Ensuring access to essential medicines starts with the materials needed to make them,” ASPR Principal Deputy Assistant Secretary Sean Kaufman stated. He described the assessment as a means of identifying vulnerabilities and informing domestic manufacturing policy.
The initiative follows federal investments in domestic production of pharmaceutical starting materials.
ASPR’s industrial base management center has supported Manus Bio in producing shikimic acid at its Augusta, Georgia, facility. The chemical is used to manufacture oseltamivir, an antiviral medicine for influenza.
The center has also supported Antheia Inc. in expanding production of thebaine at its Menlo Park, California, facility.
Thebaine is a starting material used in the manufacture of medicines for pain management, alcohol use disorder and opioid overdose reversal.
Both projects are intended to increase domestic availability of materials used in pharmaceutical production.
The assessment also supports President Donald Trump’s Executive Order 14336, which addresses pharmaceutical supply chain resilience through the Strategic Active Pharmaceutical Ingredients Reserve.
The federal review will provide a basis for identifying manufacturing gaps and directing future investment toward materials considered important to medicine availability and emergency preparedness.
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