US-CONGRESS BILLS-119hr9599ih: Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency in 340B Act; SECURE 340B Act
The SECURE 340B Act (H.R. 9599) proposes new compliance requirements for drug manufacturers participating in the 340B Drug Pricing Program, including enhanced reporting, audit obligations, and penalties for overcharges. The bill aims to increase transparency and prevent duplicate discounts, affecting pricing and contracting practices.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 22, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that participate in the 340B program should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective upon enactment; implementation timelines may vary by provision. Monitor for final rulemaking.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
New requirements for manufacturers to report 340B ceiling prices, conduct annual audits, and face civil monetary penalties for non-compliance. The bill also clarifies definitions and prohibits group purchasing organization (GPO) prohibitions for certain covered entities.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that participate in the 340B program
What you must do
Review current 340B compliance programs, update pricing and reporting systems, and prepare for potential audits and increased reporting obligations.
Deadline
Effective upon enactment; implementation timelines may vary by provision. Monitor for final rulemaking.
Source: https://www.govinfo.gov/app/details/BILLS-119hr9599ih
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