FDA Issues Warning Letter to McKesson Corp.

FDA Commissioner Dr. Scott Gottlieb announced Feb. 12 that the agency has issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for what he described as "violations highlighted by a concerning tampering incident that involved opioid medications."

FDA Commissioner Dr. Scott Gottlieb announced Feb. 12 that the agency has issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for what he described as "violations highlighted by a concerning tampering incident that involved opioid medications." Gottlieb announced it in a statement about FDA's continuing efforts to prevent the distribution of illegal opioids and further secure the U.S. drug supply chain.

Those efforts include increased enforcement to interdict packages containing illegal products sent by mail. FDA has sent a series of warning letters in teh past year to online networks, operating at least 70 websites and illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, and the agency hosted Internet stakeholders and thought leaders, government entities, academic researchers, and advocacy groups at an Online Opioid Summit in June 2018 to discuss ways to collaboratively take stronger action to reduce the availability of illegal opioids online, he noted.

The warning letter is addressed to John H. Hammergren, chairman and CEO of McKesson, who is retiring effective March 31, 2019. Brian Tyler, the company's president and chief operating officer, will succeed Hammergren as CEO effective April 1.

The letter alleges that McKesson violated the act, which requires manufacturers, repackagers, wholesale distributors, and dispensers to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. During an inspection from June 25 to July 3, 2018, at McKesson's headquarters, FDA inspectors found that the company failed to sufficiently respond to notifications that there were illegitimate products in their supply chain or to quarantine and investigate suspect products and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires, the letter states.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - May 2022

    May 2022

    Featuring:

    • WEARABLE TECHNOLOGY
      How Wearable Technology is Transforming Safety and the Industrial Workplace
    • TRAINING: CONFINED SPACES
      Five Tips to Improve Safety in Confined Spaces
    • INDUSTRIAL HYGIENE
      Monitor for Asbestos to Help Save Lives
    • PPE: FALL PROTECTION
      Fall Protection Can Be Surprising
    View This Issue