1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution

 
• By Bowman Cox

Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.

Diethyelen glycol and ethylene glycol adulterants
why so much deg/eg testing is needed • Source: Shutterstock

The US Food and Drug Administration dove into action after several hundred deaths in multiple countries were linked in recent months to medicines adulterated by diethylene glycol and ethylene glycol substitution, and heightened oversight can be expected to continue.

The DEG/EG adulteration “is probably the scariest thing that we’re seeing right now in the excipient space,” Francis Godwin, director...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

New US FDA Program Encouraging Domestic Manufacturing May Be ‘Very Selective’

 
• By Sarah Karlin-Smith

Pharmaceutical manufacturers encouraged the FDA to consider including expansions and modifications of existing US drug facilities in the PreCheck program.

US Tariffs And Geopolitical Tensions Push EU To New Trade Routes And Infrastructure Growth

 
• By Francesca Bruce

The EU is diversifying its trading partners, which means that new markets may open up to the pharmaceutical industry, countering transatlantic tensions.

Homework Avoidance: US FDA’s Upfront Effort For CMC Pilot Dissuades Participation

 
• By Bridget Silverman

The clarity on quality topics provided by the CMC Readiness Pilot (CDRP) is worth the work of preparing a comprehensive development review and multiple meetings, participants from Intellia, Bicycle Therapeutics and Bristol Myers Squibb said during a Duke Margolis meeting.

Europe’s EDQM To Help New African Medicines Agency Boost Quality Framework

 
• By Neena Brizmohun

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

More from Compliance

Homework Avoidance: US FDA’s Upfront Effort For CMC Pilot Dissuades Participation

 
• By Bridget Silverman

The clarity on quality topics provided by the CMC Readiness Pilot (CDRP) is worth the work of preparing a comprehensive development review and multiple meetings, participants from Intellia, Bicycle Therapeutics and Bristol Myers Squibb said during a Duke Margolis meeting.

Europe’s EDQM To Help New African Medicines Agency Boost Quality Framework

 
• By Neena Brizmohun

Drawing on around 60 years of experience, the European Directorate for the Quality of Medicines & HealthCare will help the newly formed African Medicines Agency develop robust quality control systems.

US Confirms 15% Tariff On Japanese Drugs, But Confusion Lingers

 
• By Lisa Takagi

After tough negotiations which won the country a lower US levy on pharmaceuticals, there still appears to be some confusion within the Japanese government following President Trump's latest announcement on global pharma tariffs.