June 2023

HSCA Comments to EPA on Proposal to Reduce Ethylene Oxide Emissions (EtO) from Commercial Sterilization Facilities and Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide

On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Environmental Protection Agency (EPA) on ethylene oxide (EtO).

Please find comments regarding the proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category here.

Please find comments regarding the proposed interim registration review decision and draft risk assessment addendum for ethylene oxide (EtO) here.

HSCA Response to FDA Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Draft Guidance

On behalf of the Healthcare Supply Chain Association (HSCA), which represents the nation’s leading healthcare group purchasing organizations (GPOs), we appreciate the opportunity to comment on the Food and Drug Administration’s (FDA) draft guidance, “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.”

Click here to read the full response.