Presidential DocumentExecutive Order 143362025-15823
Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve
Primary source
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Published
August 19, 2025
Signed
August 13, 2025
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 90 Issue 158 (Tuesday, August 19, 2025)</title>
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[Federal Register Volume 90, Number 158 (Tuesday, August 19, 2025)]
[Presidential Documents]
[Pages 40223-40225]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15823]
Presidential Documents
Federal Register / Vol. 90 , No. 158 / Tuesday, August 19, 2025 /
Presidential Documents
[[Page 40223]]
Executive Order 14336 of August 13, 2025
Ensuring American Pharmaceutical Supply Chain
Resilience by Filling the Strategic Active
Pharmaceutical Ingredients Reserve
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered:
Section 1. Purpose. During my first term, my
Administration acted to protect the health and security
of the American people by restoring capacity for
domestic production of essential pharmaceutical
products. Executive Order 13944 of August 6, 2020
(Combatting Public Health Emergencies and Strengthening
National Security by Ensuring Essential Medicines,
Medical Countermeasures, and Critical Inputs Are Made
in the United States), directed certain executive
departments and agencies (agencies) to consider a
variety of actions to increase their domestic
procurement of Essential Medicines, Medical
Countermeasures, and Critical Inputs, as defined in
section 7 of that order, and to identify supply chain
vulnerabilities. The Food and Drug Administration
published a list of Essential Medicines, Medical
Countermeasures, and Critical Inputs in October 2020.
The Office of the Assistant Secretary for Preparedness
and Response (ASPR) within the Department of Health and
Human Services later reduced the list to 86 essential
medicines.
Nearly two in five prescription finished drug products
are made in the United States, including many of the
essential medicines. However, when it comes to Active
Pharmaceutical Ingredients (APIs), the biologically
active components of finished drug products, only about
10 percent of the APIs by volume for the finished drug
products used in the United States are made here.
During my first term, my first Administration created a
Strategic Active Pharmaceutical Ingredients Reserve
(SAPIR) to stockpile APIs. Stockpiling APIs is
advantageous as APIs are generally lower-cost and have
longer shelf lives than the finished drug products they
make. Filling the SAPIR will also insulate the United
States from the concentration of foreign, sometimes
adversary, nations in the world-wide supply of the Key
Starting Materials used to make APIs. Moreover,
Government purchases of APIs to fill the SAPIR can
encourage more domestic production of APIs.
Unfortunately, the Biden Administration failed to
advance the goal of ensuring domestic sources for
essential medicines and their precursors despite
spending billions of dollars on efforts to secure
supply chains. Domestic production and procurement did
not increase and the SAPIR is nearly empty.
Sec. 2. Filling the SAPIR with APIs for the Most
Critical Medicines. (a) Within 30 days of the date of
this order, the ASPR shall develop a list, in
consultation with agencies with scientific expertise,
the Assistant to the President for Economic Policy
(APEP), and the Assistant to the President and Homeland
Security Advisor (APHSA), of approximately 26 drugs
that are especially critical to the health and security
interests of the Nation (the critical drugs) and an
accounting of existing, available funds that can be
utilized, consistent with statutory authorities, to
finance the preparation and opening of the SAPIR
repository and to obtain and maintain the 6-month
supply of APIs for the critical drugs referenced in
subsection (c) of this section shall be provided to the
Director of the Office of Management and Budget (OMB).
The OMB shall provide assistance to the Secretary
[[Page 40224]]
of Health and Human Services to facilitate the
repurposing of available funds, consistent with law.
(b) Within 120 days of the date of this order and
subject to the availability of funds identified
pursuant to subsection (a) of this section, the ASPR
shall, in coordination with such other agencies as are
necessary, take all measures to ready the existing
SAPIR repository so that it can begin receiving and
maintaining APIs.
(c) Subject to the availability of funds identified
pursuant to subsection (a) of this section, the ASPR
shall obtain a 6-month supply of the APIs needed to
make the critical drugs to fill the SAPIR, with a
preference for obtaining domestically manufactured APIs
if possible. The ASPR shall place such APIs within the
SAPIR repository no later than 30 days after the
repository is certified by the ASPR as ready to receive
and maintain APIs.
Sec. 3. Ensuring SAPIR Resilience. (a) Within 90 days
of the date of this order, the ASPR shall provide the
APHSA, the APEP, and the OMB with an update to the
ASPR's 2022 list of 86 essential medicines and medical
countermeasures, along with a plan to:
(i) obtain from domestic manufacturers, where possible;
(ii) store; and
(iii) maintain a 6-month supply of APIs for drugs on the updated essential
medicines list if they have not already been addressed in the list of
critical drugs identified pursuant to section 2(a) of this order.
(b) The plan provided pursuant to subsection (a) of
this section shall include a proposal and cost estimate
for opening a second SAPIR repository in the United
States within 1 year of the date of this order.
Sec. 4. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
[[Page 40225]]
(d) The costs for publication of this order shall
be borne by the Department of Health and Human
Services.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
August 13, 2025.
[FR Doc. 2025-15823
Filed 8-18-25; 8:45 am]
Billing code 4150-28-P
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</html>Indexed from Federal Register on August 19, 2025.
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