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

| March 21, 2017                               

On Friday, March 17, 2017, the Health Resources and Services Administration (HRSA) posted an Interim Final Rule that extends the effective date of the final rule titled ‘340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation’, from March 21, 2017 to the new effective date of May 22, 2017 (Interim Rule). As the effective date has been delayed and may be further delayed, the original enforcement date under the final rule of April 1, 2017 will be correspondingly delayed. Commenters are invited to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. Comments must be submitted on or before April 19, 2017.

Comments may be submitted to HRSA/OPA, identified by the Regulatory Information Number (RIN) 0906-AA89, by the following methods:

  • Federal eRulemaking Portal: http://www.regulations.gov. Follow the directions on the site. This is the preferred method for submission of comments.
  • Email: 340BCMPNPRM@hrsa.gov Include the RIN in the subject line of the message.
  • Mail: Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 Fishers Lane, Mail Stop 08W05A, Rockville, MD 20857.

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.

Kaelyn Buck

Kaelyn Buck

As a Government Operations Lead, Kaelyn provides support services to pharmaceutical and biotechnological companies for compliance with complex federal and state government programs. She is an experienced professional with over 8 years of accounting experience, including over 6 years of compliance ...