Secure Drug Supply Chain Act of 2026
Sponsored By: Senator Budd, Ted [R-NC]
Introduced
Summary
Stop imports of counterfeit and adulterated drugs from the People’s Republic of China and other countries of concern. This bill would direct the Food and Drug Administration to block unlawful drug imports, expand inspections and enforcement, and boost visibility into active pharmaceutical ingredients and other key starting materials to reduce reliance on risky foreign sources.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
Stronger import rules for drug firms
If enacted, the bill would direct the HHS Secretary to use FDA powers to block counterfeit, unapproved, misbranded, or adulterated drugs from entering the United States. The Secretary would be able to refuse entry, inspect or monitor compounding facilities, and work with the Attorney General on civil and criminal enforcement. If a refused article poses a significant public health concern, the Secretary could order its destruction and require the owner or consignee to destroy it within 90 days and pay destruction costs. The bill would also bar registration or revoke registrations for establishments tied to forced labor or sanctions violations and create new prohibited acts and penalties for fraudulent reimportation or false statements.
Deadlines for HHS drug guidance
If enacted, the bill would require the HHS Secretary to issue draft guidance defining "key starting material" within 90 days of enactment and final guidance within 180 days. It would also require proposed regulations within 90 days of enactment and final regulations within 180 days after the draft guidance is issued. The amendments in the bill would not apply until 180 days after the final guidance is issued, giving regulated firms time to comply.
Quarterly drug supply reporting rules
If enacted, the bill would change drug registrant reporting from annually to quarterly. Registrants would have to report detailed data for each active ingredient, key starting material, and any "acquired intermediate": identity, total amount used in the period (in units the Secretary specifies), and the country of origin plus facility name, address, and unique facility identifier where applicable. For the first year after the final regulations take effect, detailed reporting would apply only to essential medicines sourcing such materials from China or other foreign countries of concern; after that year, the detailed rules would apply to any drug sourcing from those countries. Required records must be kept for at least five years and trade secret protections would remain in place.
Sponsors & CoSponsors
Sponsor
Budd, Ted [R-NC]
NC • R
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov