Executive Order No. 14336. Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve

• Executive Order No.: 14336
• Published date: 19 August 2025
• Date: 13 August 2025
• Citation: 90 FR 40223
• Pages: 40223-40225
• Section: Presidential Documents
• Issuer: Executive Office of the President

Presidential Documents

40223

Federal Register / Vol. 90, No. 158 / Tuesday, August 19, 2025 / Presidential Documents

Executive Order 14336 of August 13, 2025

Ensuring American Pharmaceutical Supply Chain Resilience

by Filling the Strategic Active Pharmaceutical Ingredients Re-

serve

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 Counter-

measures, 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, some-

times adversary, nations in the world-wide supply of the Key Starting Mate-

rials 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 ensur-

ing 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

VerDate Sep<11>2014 15:48 Aug 18, 2025 Jkt 265001 PO 00000 Frm 00001 Fmt 4790 Sfmt 4790 E:\FR\FM\19AUE1.SGM 19AUE1

lotter on DSK11XQN23PROD with FR_PREZDOC1

40224

Federal Register / Vol. 90, No. 158 / Tuesday, August 19, 2025 / Presidential Documents

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.

VerDate Sep<11>2014 15:48 Aug 18, 2025 Jkt 265001 PO 00000 Frm 00002 Fmt 4790 Sfmt 4790 E:\FR\FM\19AUE1.SGM 19AUE1

lotter on DSK11XQN23PROD with FR_PREZDOC1

40225

Federal Register / Vol. 90, No. 158 / Tuesday, August 19, 2025 / Presidential Documents

(d) The costs for publication of this order shall be borne by the Department

of Health and Human Services.

THE WHITE HOUSE,

August 13, 2025.

[FR Doc. 2025–15823

Filed 8–18–25; 8:45 am]

Billing code 4150–28–P

VerDate Sep<11>2014 15:48 Aug 18, 2025 Jkt 265001 PO 00000 Frm 00003 Fmt 4790 Sfmt 4790 E:\FR\FM\19AUE1.SGM 19AUE1

Trump.EPS</GPH>

lotter on DSK11XQN23PROD with FR_PREZDOC1