340B Eligibility Requirements - FAQ - Apexus

Eligibility Requirements

Overview:  

The entity types eligible to participate in the 340B Program are listed in section 340B(a)(4) of the Public Health Service Act (PHSA).  Eligible entities are divided into two main categories: 

(1) non-hospital entities described in sections 340B(a)(4)(A) through (K) of the PHSA and

(2) hospital entities described in sections 340B(a)(4)(L) through (O) of the PHSA.   

An eligible entity must register for the 340B Program and receive a unique 340B identification number to purchase and use 340B drugs for its patients.  An entity participating in the 340B Program is referred to as a covered entity.  

A covered entity may have associated sites and off-site outpatient facilities that may also be eligible for the 340B Program.  For non-hospital covered entities, associated sites that are listed in the covered entity's scope of grant, project, or contract may be eligible to register as child sites.  For hospital covered entities, HRSA's longstanding policy has been to use the latest filed Medicare cost report (59 Fed. Reg. 47884, Sept. 19, 1994).   

For the list of eligible entity types, view HRSA's website. From that page, click on the entity type for specific registration information and deadlines.

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