February 2016 - The Importance of Establishing and Following 340B Program Policies and Procedures

Office of Pharmacy Affairs UpdateFebruary 2016

The Importance of Establishing and Following 340B Program Policies and Procedures

Policies and procedures provide guidelines for decisions and actions within a 340B covered entity by promoting compliance with the 340B statute, guidance, and policy requirements while also standardizing practices throughout the organization. Policies and procedures provide clarity both internally and externally regarding how the covered entity operates a compliant 340B Program. Policies and procedures should include elements of program requirements, including methodologies for routine self-auditing and internal corrective action. Covered entities are strongly encouraged to review and update their policies and procedures for all facets of the 340B Program on a regular basis in order to improve program integrity within their organization.

In order to assist covered entities in establishing the appropriate policies and procedures that cover all aspects of the 340B Program, HRSA is providing the following list of specific areas whereby policies and procedures are recommended. HRSA's list of policies and procedures will also help covered entities mitigate their risk of non-compliance. Covered entities should be prepared to provide these policies and procedures during a HRSA audit.  These site-specific policies and procedures should reflect actual practice and, therefore, be continually monitored, evaluated and modified to reflect both the needs and work of the organization. The following link provides detailed information regarding suggested policies and procedures: 340B Policies and Procedures.

In working on the development and implementation of policies and procedures, 340B stakeholders should take further advantage of the following 340B educational resources available for covered entities, including specific examples and templates for policies and procedures.


Date Last Reviewed:  April 2017

Contact the 340B Prime Vendor Program

340B Prime Vendor Program website HRSA Exit Disclaimer
1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET)