S. 5043
Secure Drug Supply Chain Act of 2026
Sponsor: Ted Budd
2 cosponsors
Official summary
No official summary yet.
Text of the bill
(a) Ban on imports of drugs from establishments using forced labor or violating sanctions. Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended, in the third sentence—
(1) by inserting or (6) such article is a drug and the safety of such drug is based solely on information or certifications provided by a foreign government, including any inspection described in section 704(i), without routine inspections conducted by United States inspectors to verify compliance with this Act, or (7) such article is a drug and was manufactured, prepared, propagated, compounded, processed in an establishment known to have used forced labor (as defined in section 307 of the Tariff Act of 1930) or to have been in violation of sanctions imposed by the Federal Government under the International Emergency Economic Powers Act or other applicable law, as determined by the Secretary in consultation with the Secretary of Homeland Security, after 301(cc),; and
(2) by striking clauses (1) through (5) and inserting clauses (1) through (7).
(b) Destruction of Refused Articles Presenting Significant Public Health Concerns. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following:
(v) Destruction of refused articles presenting significant public health concerns
(1) In general. If the Secretary determines that an article that has been refused admission under subsection (a) presents a significant public health concern, the Secretary may issue to the owner or consignee of the article an order to destroy the article, without the opportunity for export.
(2) Deadline; costs. Not later than 90 days after the issuance of an order under paragraph (1), the owner or consignee shall destroy the article. The owner or consignee shall be responsible for the costs of such destruction.
(3) Due process. The Secretary shall provide to the owner or consignee of an article subject to an order under paragraph (1) appropriate due process prior to the destruction of the article. Such due process shall include notice and an opportunity to appear before the Secretary and introduce testimony on the destruction, in combination with the notice and opportunity to appear and introduce testimony on the refusal of admission of the article under subsection (a) or separately.
(c) Prohibition on registration of certain foreign establishments. Section 510(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is amended by adding at the end the following:
(6) Notwithstanding any other provision of this section, any establishment that knowingly used, or partnered with, contracted with, or purchased from an entity that has used, forced labor (as defined in section 307 of the Tariff Act of 1930) or that knowingly violated sanctions imposed by the Federal Government under the International Emergency Economic Powers Act or other applicable law, as determined by the Secretary in consultation with the Secretary of Homeland Security, shall not be eligible for registration under this section, and the Secretary shall revoke any registration of such an establishment that was accepted prior to the date of enactment of the Secure Drug Supply Chain Act of 2026.
(d) Prohibited acts. Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
(jjj) The unauthorized movement, or introduction or delivery for introduction into interstate commerce, including export, of an article that is subject to an order for destruction under section 801(v).
(kkk) The knowing provision of a materially false, fictitious, or fraudulent statement or representation to the Secretary that accompanies or relates to a drug imported or offered for import into the United States.
(lll) The import or offering for import into the United States of a drug that previously has been refused admission under section 801(a) or exported during the pendency of a detention, unless the person reimporting or reoffering the drug affirmatively makes reference to the original refusal or detention and establishes that the drug complies with the applicable requirements of this Act, as determined by the Secretary.
(e) Misbranded drugs. Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:
(hh) If it is a drug, including an active pharmaceutical ingredient and key starting material, imported or offered for import and the drug is accompanied by a materially false, fictitious, or fraudulent statement or representation knowingly made by the person importing the drug or offering the drug for import.
(f) Adulterated drugs. Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the following:
(k) If it is an active pharmaceutical ingredient that has not been approved as part of an application under section 505 of this Act or 351 of the Public Health Service Act, or otherwise approved or authorized for use in a drug or device, and it was manufactured, prepared, propagated, compounded, or processed in—
(1) an establishment that was not inspected within the immediately preceding 3-year period; or
(2) in the case of an establishment located in a foreign country with which the Secretary has an arrangement or agreement under section 809 to recognize the inspection of establishments by the government or an agency of the government of such country, within the immediately preceding 5-year period.
(l) If it is a drug that was manufactured, prepared, propagated, compounded, or processed in an establishment that the Secretary, in consultation with the Secretary of Homeland Security, determines—
(1) knowingly utilizes forced labor (as defined in section 307 of the Tariff Act of 1930); or
(2) is in violation of sanctions imposed by the Federal Government under the International Emergency Economic Powers Act or other applicable law, including an establishment that is designated to the list of specially designated nationals and blocked persons maintained by the Office of Foreign Assets Control of the Department of the Treasury or owned 50 percent more or more, directly or indirectly, by one or more such designated persons.
(g) Regulations. The Secretary of Health and Human Services shall—
(1) not later than 90 days after the date of enactment of this Act, issue proposed regulations implementing the amendments made by this section; and
(2) not later than 180 days after issuance of the draft guidance described in paragraph (1), finalize such guidance.
(h) Applicability. The amendments made by this section shall apply beginning on the date that is 180 days after the final guidance under section 6(2) is issued.