Define 'commercially available drug product' to prevent 503A compounders from mass-producing approved medicines.
I will define 'commercially available drug product' to prevent 503A compounders from mass-producing approved medicines.
Occurrences
Evidence
Section 2 amends 503A to define a drug product that is 'essentially a copy of a commercially available drug product' and states that 'commercially available drug product' includes a drug product sold in the commercial marketplace in the United States and manufactured in facilities required to comply with section 501(a)(2)(B).
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.
Assessments
Banks introduced S. 3794 in the 119th Congress, which directly contains the promised definition of 'commercially available drug product' and would tighten the 503A copy standard. However, the bill is only introduced and referred to committee, with no enactment or final federal policy change shown. Because Banks is still in the same federal term and the vehicle remains pending rather than defeated, the promise is not delivered but remains unresolved, with a clear effort badge for the introduced legislation.