340B Industry Update

Written By David Wooddell

HRSA Proposes New 340B Enrollment & Recertification Requirements

On August 7, 2025, the Health Resources and Services Administration (HRSA) released a proposed Information Collection Request (ICR) that would change how covered entities register and recertify for the 340B Drug Pricing Program.

These updates are not final and remain open for public comment until October 6, 2025. If approved, they could take effect in late 2025 or early 2026.

    • STD Grantees (Most Impacted)

      • Primary grantees and subrecipients would need to submit eligibility documentation (Notice of Award, subrecipient agreements) both at initial enrollment and annually at recertification.

    • Shipping Address Classification

      • Covered entities must classify each OPAIS shipping address as a pharmacy, healthcare delivery site, or other location.

      • If a site’s address changes, entities must confirm the site still receives qualifying funds and remains open.

    • Family Planning Grantees

      • Required to include the time period of federal assistance when registering or recertifying.

    • Urban Indian & Tribal FQHCs (Type 638)

      • Must submit their tribal agreement number at both enrollment and recertification.

    • Hospitals

      • Mostly technical updates—aligning terminology with CMS and clarifying trial balance/Worksheet S uploads.

  • ✔️ Review the Proposal – Visit the Federal Register to see the full details.
    ✔️ Gather Documentation Early – Especially STD grantees: locate your NOAs and subrecipient agreements now.
    ✔️ Verify OPAIS Records – Ensure shipping addresses are accurate and properly classified.
    ✔️ Prepare Ahead of Time – Begin collecting documents and planning for compliance in case changes go live by late 2025 or early 2026.

  • At NPS Pharmacy, we believe in radical transparency—helping partners navigate 340B requirements with confidence. Staying ahead of regulatory updates not only ensures compliance but also protects program savings and sustainability.

    Our team is here to help your organization:

    • Interpret new HRSA guidance

    • Prepare documentation in advance

    • Identify strategies to maximize 340B impact under new rules

📩 Questions or Need Support?
Contact our Strategic Partnerships Team at partnership@npspharmacy.com or reach out directly to your NPS representative.

Together, we’ll ensure your 340B program remains compliant, effective, and sustainable.

David Wooddell

Director of Marketing & Communications, NPS Pharmacy