Effective Date: 10/01/2026 (See HHSAR CD 2026-22)
Subpart 325.70 – Restrictions on Foreign Acquisition of Covered PPE
325.7000 Scope of subpart.
325.7001 Definitions.
325.7002 Policy.
325.7003 Exceptions.
325.7004 Solicitation provision and contract clause.
Subpart 325.70 – Restrictions on Foreign Acquisition of Covered PPE
325.7000 Scope of subpart.
This subpart—
(a) Implements section 70953 of the Make PPE in America Act (Pub. L. 117-58, Div. G, Title IX, Subtitle C (Nov. 15, 2021)) requirements that limit buying covered personal protective equipment (PPE) from foreign sources.
(b) Applies to solicitations, contracts, and Government Purchase Card (GPC) transactions at any dollar value.
325.7001 Definitions.
As used in this subpart—
Component means as defined in FAR 25.003.
Covered personal protective equipment (PPE) means surgical masks, respirator masks, powered air purifying respirators (and required filters), face shields, protective eyewear, gloves, gowns (disposable or reusable), head and foot coverings, and other gear or clothing that protects people from transmission of disease.
Domestic PPE end product means a covered PPE, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.
Foreign-assembled domestic PPE end product means a covered PPE that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States.
Foreign PPE end product means a covered PPE that is other than a domestic PPE end product or foreign-assembled domestic PPE end product.
Wholly foreign PPE end product means a foreign PPE end product that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced outside the United States.
325.7002 Policy.
Unless an exception at 325.7003 applies—
(a) HHS acquisition officials, contracting officers, and authorized GPC cardholders must buy only domestic PPE end products.
(b) Any contract for covered PPE must have a base period of performance of at least two years, plus any option periods.
(c) The GPC can only be used to purchase covered PPE if the covered PPE is part of a contract, or other authorized acquisition instrument that complies with this subpart. Standalone purchases of covered PPE on the GPC are not allowed.
325.7003 Exceptions.
When one of the following exceptions applies, the contracting officer may acquire covered PPE without regard to the restrictions in 325.7002(a) and (b):
(a) Emergency needs. When the HHS Secretary—
(1) Maximizes sources for foreign-assembled domestic PPE end products; and
(2) Certifies every 120 days that alternative procedures are needed to meet urgent public health needs.
(b) Nonavailability or unreasonable cost. When—
(1) A covered PPE item or component includes a material on the FAR 25.104 list with a nonavailability determination; or
(2) The HHS Secretary determines that domestic PPE end products are not available in sufficient quantity and quality at U.S. market prices and certifies every 120 days that the exception is necessary to respond to a public health emergency.
325.7004 Solicitation provision and contract clause.
(a) Insert the clause at 352.225-70, Made in America – Covered Personal Protective Equipment, in solicitations, orders, and contracts, regardless of dollar value, when procuring covered PPE.
(b) Insert the provision at 352.225-71, Made in America Certificate – Covered Personal Protective Equipment, in solicitations containing the clause at 352.225-70.