Require FDA inspections of outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.
I will require FDA inspections of drug compounding outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.
Occurrences
Evidence
Key Provisions of the Safeguarding Americans from Fraudulent and Experimental Drugs (SAFE) Act: ... Require FDA inspections of outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.
Sponsor: Sen. Banks, Jim [R-IN] (Introduced 02/05/2026). Latest Action: Senate - 02/05/2026 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Tracker: This bill has the status Introduced.
Once a facility is registered, the facility will be added to the list of facilities FDA intends to inspect. Outsourcing facilities are to be inspected according to a risk-based schedule. ... FDA expects to inspect newly registered outsourcing facilities within two months of initial registration, if the facility has not been previously inspected.
Assessments
Banks sponsored the SAFE Drugs Act in February 2026, and the bill included the promised requirement for FDA inspections before large-scale compounding and every two years afterward. However, the bill was only introduced and referred to committee, with no evidence it was enacted or that FDA policy otherwise adopted the promised statutory inspection schedule. Because he made a concrete legislative attempt but the promised outcome has not been delivered, this is a failed promise with effort credit.