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

Deadly COVID-19 Hand Sanitizer Production Surge Prompted US FDA's New Import Alert Category

 
• By Joanne S. Eglovitch

New import alert category and border testing required after reduced standards put dangerous sanitizers into hands of US consumers.

Coronavirus prevention medical surgical masks and hand sanitizer gel for hand hygiene corona virus protection.
US FDA Creates New Import Category In Responding To Loosening Manufacturing Standards • Source: Shutterstock

The US Food and Drug Administration has created a new import alert category, 66-78, to stem the importation of contaminated hand sanitizers, which has caused nationwide adverse events and some deaths.

The agency's action responds to methanol contamination that followed a loosening standards for these products to enable a swift increase...

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

EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

 
• By Eliza Slawther

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

More from Compliance