Require 503A compounders to report to the FDA any out-of-state shipments of compounded drugs containing approved active ingredients above a prescription threshold.
I will require 503A drug compounders to report to the FDA any out-of-state shipments of compounded drugs containing approved active ingredients above a prescription threshold.
Occurrences
if a pharmacy, facility, or physician compounds, more than 20 times in a single month for patients who reside outside the State in which the compounding occurs, any drug product that contains any active ingredient found in a commercially available drug product ... shall submit a report to the Secretary
Evidence
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The Senate office’s legislation page lists S.3794, the SAFE Drugs Act of 2026, with latest action: 'Read twice and referred to the Committee on Health, Education, Labor, and Pensions.'
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Banks said he introduced the SAFE Drugs Act, and the listed key provisions include: 'Require 503A compounders to report to the FDA any out-of-state shipments of compounded drugs containing approved active ingredients above a prescription threshold.'
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08-04-2026 | S.3794 | SAFE Drugs Act of 2026 Latest Action: Placed on Senate Legislative Calendar under General Orders. Calendar No. 524.
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Beginning with the first calendar year that begins after the date of enactment of the SAFE Drugs Act of 2026, not later than January 15 of each calendar year
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524 S. 3794 A bill to amend the July 27, 2026.--Senator Senators Banks Federal Food, Drug, and Cassidy, Committee on and Heinrich Cosmetic Act to further Health, Education, regulate compounding Labor, and Pensions, pharmacies and with an amendment in outsourcing facilities, the nature of a and for other purposes. substitute. (No written report.)
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The SAFE Drugs Act passed the Committee with a vote of 17-5 and now heads to the Senate floor.
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S. 3794.-- To amend the Federal Food, Drug, and Cosmetic Act to further regulate compounding pharmacies and outsourcing facilities, and for other purposes. Referred to Health, Education, Labor, and Pensions Feb. 5, 2026. Reported amended July 27, 2026; no written report.
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524 S. 3794 A bill to amend the July 27, 2026.--Senator Senators Banks Federal Food, Drug, and Cassidy, Committee on and Heinrich Cosmetic Act to further Health, Education, regulate compounding Labor, and Pensions, pharmacies and with an amendment in outsourcing facilities, the nature of a and for other purposes. substitute. (No written report.)
Assessments
Banks introduced S.3794, the SAFE Drugs Act of 2026, which directly included the promised requirement for 503A compounders to report qualifying out-of-state shipments to FDA. However, current official bill status shows the measure only reached introduction and referral to the Senate HELP Committee on February 5, 2026, with no enactment or implementation. This is a serious same-term legislative attempt, but the promised federal requirement has not been delivered.