Secure Drug Supply Chain Act of 2026

(C)

(i) The annual report required under subparagraph (A) shall include the information described in clause (ii) with respect to drugs, in accordance with the following:

(I) In the 1-year period beginning on the effective date of the final regulations described in section 4(c) of the Secure Drug Supply Chain Act of 2026, the information described in clause (ii) shall be included in the report under subparagraph (A) with respect to any drug that—

(aa) is included on the Essential Medicines List maintained by the Food and Drug Administration pursuant to Executive Order 13944 (85 Fed. Reg. 49929); and

(bb) is a drug for which any active pharmaceutical ingredient, key starting material, or acquired intermediate is sourced from the People's Republic of China or another foreign country of concern.

(II) Beginning on the day after the last day of the 1-year period described in subclause (I), the information described in clause (ii) shall be included in the report under subparagraph (A) if it is a drug for which any active pharmaceutical ingredient, key starting material, or acquired intermediate is sourced from the People's Republic of China or another foreign country of concern.

(ii) The information described in this clause is the following, as applicable:

(I) The identity of each active pharmaceutical ingredient, key starting material, and acquired intermediate used by the registrant to manufacture the listed drug.

(II) The total amount of each such active pharmaceutical ingredient, key starting material, and acquired intermediate used by the registrant to manufacture the listed drug during the reporting period, expressed in such units as the Secretary shall specify.

(III) The country of origin of each such active pharmaceutical ingredient, key starting material, and acquired intermediate, including the name, address, and unique facility identifier (as applicable) of each establishment at which such active pharmaceutical ingredient, key starting material, or acquired intermediate was manufactured.

(iii) Information reported under this subparagraph shall include the country of origin without regard to any distribution or shipment through a country other than the country of origin.

(iv) A person required to report information under this subparagraph shall maintain such records and supporting documentation as the Secretary shall require to verify the accuracy and completeness of information submitted under this paragraph, for a period of not less than 5 years, and shall make such records available to the Secretary upon request.

(D) Not later than 18 months after the 1-year period described in subparagraph (C)(i)(I) ends, and annually thereafter, the Secretary shall, based on the reports submitted under subparagraph (A), issue a confidential report to Congress that—

(i) analyzes United States vulnerabilities arising from dependence on active pharmaceutical ingredients and key starting materials sourced from the People's Republic of China or other foreign countries of concern, including any such ingredients or materials with origins in the People's Republic of China or another foreign country of concern that are sourced through third countries;

(ii) identifies the proportion of drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the United States that depend on active pharmaceutical ingredients and key starting materials sourced from the People's Republic of China or other foreign countries of concern, disaggregated by country of origin to the extent practicable;

(iii) determines specific supply chain vulnerabilities, including drug classes or therapeutic categories for which dependence on active pharmaceutical ingredients and key starting materials sourced from the People's Republic of China or another foreign country of concern, poses a risk to public health or national security; and

(iv) tracks trends over time in dependence on active pharmaceutical ingredients and key starting materials sourced from the People's Republic of China or another foreign country of concern, including anonymized aggregate data reflecting increases or decreases in such dependence.

(E) In this paragraph:

(i) The term acquired intermediate means a material produced during steps in the manufacture of an active pharmaceutical ingredient that undergoes further molecular change or purification before it becomes an active pharmaceutical ingredient and is manufactured at an establishment other than the establishment at which the active pharmaceutical ingredient is manufactured.

(ii) The term country of origin means, with respect to an active pharmaceutical ingredient, key starting material, or acquired intermediate, each country in which such ingredient, intermediate, or material was manufactured into its chemical identity through chemical synthesis, fermentation, extraction, purification, or other manufacturing process including each country at which such active pharmaceutical ingredient, key starting material, or acquired intermediate was repackaged, relabeled, finished, blended, or tested.

(iii) The term foreign country of concern has the meaning given such term in section 10612(a) of the Research and Development, Competition, and Innovation Act.