After much anticipation, the draft mega-guidance for the 340B program has been released for review and comment. As we familiarize ourselves with the document, Hudson Headwaters will take note of any proposed changes and their potential impact to ensure that the benefit of the 340B program remains with covered entities. We encourage our clients and other covered entities to do the same and to submit responses to any concerns that arise. The deadline for any comments is October 27, 2015.
There are three ways to submit feedback on the proposed mega-guidance:
- Submit electronically, via the Federal eRulemaking Portal. This is the preferred method for the submission of comments.
- Submit via e-mail to: 340BGuidelines@hrsa.gov. Include RIN 0906-AB08 in the subject line of the message.
- Submit via mail to: Krista Pedley, Director, Office of Pharmacy Affairs (OPA), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Mail Stop 08W05A, Rockville, Maryland 20857
We welcome you to contact us if you have questions or concerns. Reach out to your dedicated client representative, send us an email at firstname.lastname@example.org or give us a call at 1-855-835-340B.