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
In the case of a large-scale outsourcing facility, the risk-based inspections under paragraph (4) shall include an inspection prior to such facility compounding any drug product for the first time; and the reinspection of such facility not less than biennially
Evidence
legacy_unverified · Source version not recorded · locator unknown
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.
legacy_unverified · Source version not recorded · locator unknown
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.
legacy_unverified · Source version not recorded · locator unknown
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.
unverified · Source version 61960 · locator unknown
Last Action Date Listed: July 27, 2026. Actions: Mr. Banks introduced the bill; it was referred to HELP, then reported by Mr. Cassidy, with an amendment. Bill Version: Reported in Senate (RS).
unverified · Source version 61957 · locator unknown
The reported bill says to strike out all after the enacting clause. The deleted Section 4 would have required inspection before first compounding and reinspection not less than biennially; the substitute text contains reporting and labeling sections instead.
Assessments
Banks introduced and materially advanced the SAFE Drugs Act in the 119th Congress, and the introduced proposal included the promised FDA pre-large-scale inspection and biennial follow-up inspection requirement. However, the measure had not been enacted, and the Senate-reported substitute removed the exact inspection mandate, leaving no binding federal requirement matching the promise. Existing FDA practice remains risk-based rather than a statutory every-two-years inspection rule. This is a serious same-term legislative effort, but the promised outcome was not delivered.
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.