8-KOther Events

Cencora, Inc. 8-K Report, Corporate Update (May 20, 2019)

Filed May 20, 2019For Securities:COR

Summary

Cencora, Inc. (formerly AmerisourceBergen Corporation) is providing an update on its subsidiary PharMEDium concerning a consent decree with the U.S. Food and Drug Administration (FDA) and the Department of Justice (DOJ). The agreement, pending court approval, outlines requirements for PharMEDium's compounding facilities and operations. While commercial operations can continue at its Dayton, New Jersey and Sugar Land, Texas facilities, and administrative operations at its Lake Forest, Illinois headquarters, these are contingent upon strict compliance with new regulations and independent audits. The consent decree specifically addresses the Memphis, Tennessee facility, requiring a work plan and FDA-approved independent audits before commercial operations can resume. Additionally, PharMEDium has ceased production at its Cleveland, Mississippi facility and will stop holding and distributing drugs from this location by May 24, 2019. The company acknowledges potential risks and uncertainties, including compliance costs and operational limitations, which could materially impact future results.

Key Highlights

  • 1PharMEDium has reached an agreement on the terms of a consent decree with the FDA and DOJ, pending court approval.
  • 2Commercial operations can continue at Dayton, NJ and Sugar Land, TX facilities, subject to stringent cGMP compliance and independent audits.
  • 3Memphis, TN facility operations require an FDA-approved work plan and independent cGMP expert certification before resuming.
  • 4PharMEDium's Cleveland, MS facility has ceased production and will stop drug holding/distribution by May 24, 2019.
  • 5The company anticipates compliance costs and potential operational limitations as a result of the consent decree.
  • 6PharMEDium may petition the court for relief from the consent decree after five years of continuous compliance.

Frequently Asked Questions

The consent decree allows certain facilities to continue operations but imposes strict requirements, including audits by independent cGMP experts, to ensure compliance with manufacturing standards. The Memphis facility requires specific approvals before resuming operations, and the Cleveland facility's operations are being wound down.

Commercial operations can continue at the Dayton, NJ and Sugar Land, TX facilities, provided they meet the consent decree's requirements. The Memphis, TN facility can resume operations only after satisfying specific FDA-approved work plans and independent audits. The Cleveland, MS facility's operations are ceasing.

The company acknowledges that compliance with the consent decree may lead to significant compliance costs and potential limitations on production or distribution, which could adversely affect future financial results. These factors are subject to risks and uncertainties.

PharMEDium may petition the court for full or partial relief from the consent decree after five years, provided that all obligations have been satisfied and there has been continuous compliance with the decree during that period.