I will require FDA inspections of drug compounding outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.

Require FDA inspections of outsourcing facilities before large-scale compounding begins, with follow-up inspections every two years.

Banks pledges to mandate regular FDA inspections before and during operations at drug outsourcing facilities.

Senator Jim Banks Introduces SAFE Drugs Act to Crack Down on Risky and Fraudulent Weight Loss Drugs
primary · press_release · model gpt-4.1

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

The bill would require pre-compounding inspections of large-scale outsourcing facilities and reinspections at least every two years.

BILLS-119s3794is.pdf
primary · other · model gpt-5.4-mini

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.

Banks publicly announced and advanced a bill containing the specific inspection requirement in the promise, showing concrete legislative effort.

partial same_term A for effort

Senator Jim Banks Introduces SAFE Drugs Act to Crack Down on Risky and Fraudulent Weight Loss Drugs
primary · model gpt-5.4-mini · confidence 98%

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.

The bill that would have implemented the promise was introduced, but it was only referred to committee and not enacted.

never same_term A for effort

S.3794 - A bill to amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes
secondary · model gpt-5.4-mini · confidence 99%

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.

FDA’s current framework is risk-based and does not impose a statutory every-two-years inspection rule for outsourcing facilities, so the promise was not already satisfied by existing FDA practice.

never unknown

Questions and Answers: Outsourcing Facility Registration
secondary · model gpt-5.4-mini · confidence 93%