US-CONGRESS BILLS-119hr9599ih: Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency in 340B Act; SECURE 340B Act
The SECURE 340B Act introduces new compliance requirements for pharmacies participating in the 340B drug pricing program, including enhanced oversight of controlled substances, mandatory reporting to prescription drug monitoring programs (PDMPs), and stricter recordkeeping for diversion prevention.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on July 22, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Independent pharmacies, retail chains, compounding pharmacies, and long-term-care pharmacies that participate in the 340B program or dispense controlled substances. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective upon enactment (likely within 90 days of passage). 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 Pharmacy & Controlled Substances 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 340B covered entities: (1) mandatory PDMP query before dispensing controlled substances, (2) enhanced suspicious order monitoring and reporting to DEA, (3) updated recordkeeping for 340B drug diversion prevention, (4) potential loss of 340B eligibility for non-compliance.
Who it affects
Independent pharmacies, retail chains, compounding pharmacies, and long-term-care pharmacies that participate in the 340B program or dispense controlled substances.
What you must do
Review current PDMP integration and suspicious order monitoring processes; update policies to comply with new federal standards; train staff on enhanced reporting obligations.
Deadline
Effective upon enactment (likely within 90 days of passage). Monitor for final rulemaking.
Source: https://www.govinfo.gov/app/details/BILLS-119hr9599ih
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