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340B Program Updates

340B Drug Pricing Program covered entities must ensure program integrity and maintain accurate records documenting compliance with all 340B Program requirements.

Final

Issued by: Health Resources and Services Administration (HRSA)

Program Updates

OPA Program Update – December 2019 12/19/2019

OPA Program Update – October 2019 10/11/2019

OPA Program Update – May 2019 05/01/2019

OPA Program Update - March 2019 03/01/2019

OPA Program Update - December 2018 12/01/2018

340B Manufacturer Update 08/14/2018

340B OPAIS Enhancements – Registration Components (PDF - 26 KB) 07/23/2018

340B Registration Reviews and Additional Program Integrity Analysis 07/01/2018

Best Practices for Covered Entities: Resolving Contract Pharmacy Related Non-Compliance 06/26/2018

340B Program Performance and Quality: Audit Findings and CAPs 05/11/2018

New 340B Office of Pharmacy Affairs Information System – Registration Component (PDF - 19 KB) 08/17/2017

340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (PDF - 55 KB) 01/06/2017

HRSA OPA Manufacturer Update 12/15/2016

Contract Pharmacy: Important Tips 08/12/16

340B Pricing System: Manufacturers 340B Database Verification and Other Updates 04/15/16

The Importance of Establishing and Following 340B Program Policies and Procedures 02/12/16

340B Audits: News to Use in 2016 01/8/16

340B Price Unavailability: How to Report to HRSA 12/17/15

340B Peer-to-Peer Program and Best Practices 11/20/2015

The Medicaid Exclusion File: Important Clarifications 10/09/2015

340B Resources 08/17/2015

340B Covered Entity Recertification 07/10/2015

Contract Pharmacies 06/17/2015

340B Pricing System 05/08/2015

Program Integrity: Best Practices for Hospital Registrations 03/26/2015

Program Integrity: Best Practices from Leading Practice Sites 02/23/2015

Database Upgrades 01/09/2015

Policy Clarification: Duplicate Discounts 12/12/2014

Best Practices of a 340B Peer-to-Peer Leading Practice Site 11/07/2014

Grantee Site Visits 10/10/2014

Self-Disclosures 09/08/2014

340B Hot Topics 08/04/2014

340B Audit Process 07/03/2014

340B Staffing Investments 06/13/2014

Program Audits 05/09/2014

Hospital Registration Overview 04/08/2014

Manufacturer Compliance 03/06/2014

Contract Pharmacy Oversight 02/05/2014

340B Drug Pricing Program: Important Benefit, Significant Responsibility 01/09/2014

Date Last Reviewed:  March 2020

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.