Understanding 340B Compliance graphic image

Once you’ve determined your 340B Eligibility, you need to understand what defines compliance in the 340B program.

As you probably know, to participate in the 340B program provides a substantial discount on qualifying outpatient medication purchases. Which then convert into additional financial resources, that then are used to help patients in need. Maintaining a compliant program is necessary to have access to these critical resources.

340B Compliance involves the following attributes:

(for more information, please click on their individual hyperlinks).

The potential causes of 340B noncompliance, according to HRSA, include:

  • Duplicate Discounts
  • Diversion
  • Incorrect 340B database information

Failure to comply with program requirements can result in fines, as well as the expulsion from the 340B program.

An essential part to maintaining a compliant 340B program is the integration of self-audits by the covered entity. Initiating routine audits, such as monthly audits of mixed-use and contract pharmacy(ies), quarterly reviews of the 340B database, and annual mock HRSA audits (internal and/or external), helps to ensure program compliance and allows the covered entity to be well prepared for a HRSA or a manufacturer audit.

The topic of 340B compliance is vast and can include many different factors from a variety of regulations. This article is not meant to substitute any of your own research, but rather it is here only to act as a guide on how to proceed with your compliance. You should be observant of HRSA regulations and subscribe to industry news sources, such as 340Bhealth.org or the 340Brief webinar series, powered by CaptureRx. For more information, please contact your CRM.

All information, content, and materials available on this site are for general informational purposes only.

The information provided on this website does not, and is not intended to, constitute legal advice.

You should not act upon any such information without first seeking qualified professional counsel for your specific matter.


  1. https://www.pharmacytimes.com/publications/health-system-edition/2016/november2016/palliative-care-the-pharmacists-role
  2. https://www.hrsa.gov/
  3. https://www.capturerx.com/2019/04/what-is-your-340b-eligibility/