340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Further Delay of Effective Date

| May 23, 2017                               

On Friday, May 19, 2017, the Health Resources and Services Administration (HRSA) posted an update that further delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017))  titled ‘340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation’, from May 22, 2017 to the new effective and enforcement date of October 1, 2017 (Final Rule- Further Delay of Effective Date).

After the issuance of the interim final rule posted on March 17, 2017 that delayed the effective date of the final rule to May 22, 2017, HRSA invited commenters to provide their views on a further delay of the effective date to October 1, 2017. HRSA reviewed the 51 comments received, and believes that delaying the effective date of the final rule to October 1, 2017 will provide regulated entities sufficient time for compliance and mitigate any concerns with implementation.  The final rule is closed from further comments.

To read more about what manufacturers need to know, please read the following blog by Thomas Benton and Marcy Imada titled ‘What manufacturers need to know about the new Final Rule on the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties’ that was published January 20, 2017.

Tara Winchell

Tara Winchell

Tara is a Government Operation Lead and provides support services to pharmaceutical and biotechnological companies for compliance with complex federal and state government programs. She received her Master’s in Accounting from the University of Florida and is a CPA with over 3+ years of financial report...



Leave a Reply

Your email address will not be published. Required fields are marked *

* Copy This Password *

* Type Or Paste Password Here *