ASPR 86 Essential Medicines: OMB Wants Idle Capacity Declared by 26 October

The Office of Management and Budget opened a request for information on domestic and near-shore manufacturing of the ASPR 86 essential medicines. It seeks responses from the companies that already own the plants. The notice appeared in the Federal Register on 25 September 2026 as document 2026-19646 (91 FR 60983). It directs pharmaceutical, chemical, and petrochemical manufacturers to report unused capacity and planned new capacity for finished dose forms (FDF), active pharmaceutical ingredients (API), and key starting materials (KSM) tied to the ASPR 86 list.

Responses must reach regulations.gov by 26 October 2026. OMB will not accept mailed paper submissions. Electronic filings received after the deadline may not be considered.

Why the government is asking

The notice frames domestic supply of essential medicines as a national security issue. Its goal is to secure production of the ASPR 86 medicines and their precursors inside the United States or at near-shore locations within eighteen months and to cut dependence on output from foreign entities of concern. OMB states that most essential medicine APIs are not produced domestically, which leaves the country exposed to foreign supply disruptions, and that a majority of the key starting materials needed for generic medicines are not manufactured in the United States either.

Participation is open to any entity that is not a Foreign Entity of Concern. The notice defines an FEOC as a person owned by, controlled by, or subject to the jurisdiction or direction of the government of China, Russia, Iran, or North Korea.

What the ASPR 86 essential medicines list covers

The ASPR 86 list of essential medicines is attached to the RFI. OMB also requests equivalent information on two antibiotics that are not on the list, amoxicillin and ciprofloxacin, because of potential supply chain vulnerabilities. Schedule 2 controlled substances and branded drugs on the ASPR 86 list are not priorities for this request.

Idle capacity versus new capacity

OMB splits the submission into two question sets and asks respondents to break their answers out by FDF, API, and KSM. A short entity overview asks for the legal entity name, headquarters location, and the unique entity identifier if the company is registered in the System for Award Management.

The two technical question sets cover the same ground and differ on facility status and timing:

What OMB asks for	Idle capacity	New capacity
Identifier	Molecule name, description, national drug code	Molecule name, description, national drug code
Manufacturing site	Location of the existing site	Location of the existing or planned site
Facility status	Not asked	Existing, brownfield or greenfield, and whether funding for construction or renovation is secured
Capacity	Current production, unused capacity, timeline to reach full operational capacity	Level of planned production
Demand and price	Price per unit needed to operate at full capacity	Demand level and projected cost per unit needed to sustain long-term domestic viability
Regulatory compliance	Current FDA registration status for each molecule and national drug code	Current FDA registration status
Technical capabilities	Confirmation of FDF, API and KSM synthesis or formulation capabilities	Same
Sourcing strategies	Supply chain mapping for upstream inputs, including countries of origin	Same
Financing	Debt, equity, offtake contract or other, and the reason for it, such as restart cost or additional labor	Same, for establishing new production
Cost considerations	Industry perspectives on key cost drivers	Industry perspectives on key cost drivers

Source: Federal Register 91 FR 60983, section 5.

What it means for suppliers

The RFI offers something back. Historical federal spend data and an API and KSM map are the inputs a manufacturer needs before quoting a unit price for full capacity, and OMB is asking for those quotes in writing with a deadline attached. A company that answers is, in effect, pricing the molecules the government wants onshore. That is a different exercise from the phased tariffs used to encourage reshoring of generic drug production, which act on imports rather than on capacity.

The request lands while drug shortages persist at major US cancer centres, and OMB’s questionnaire is narrower than the market. It covers 86 listed molecules plus amoxicillin and ciprofloxacin, not the whole generic catalogue.

The spend data and supply chain mapping OMB promises address the visibility gap that medicine shortages management depends on, where a complete picture of upstream inputs is hard to assemble.

Suppliers outside the United States will read the notice for its method as much as its content. South Africa has run into the same arithmetic, with pharmaceutical localisation under pressure from cheaper imports, and the question there is the one OMB is now putting to US firms in writing: who keeps capacity alive, and at what unit price. Aspen Pharmacare’s manufacturing rebound is the local version of that bet.

Source: Request for Information; Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List, 91 FR 60983 (25 September 2026). Official PDF: govinfo 2026-19646.