FDA Releases Temporary New Guidance on Hand Sanitizer

by TLM


The FDA has recently issued a new guidance on alcohol-based hand sanitizers. You can download the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Emergency Immediately in Effect for Industry by clicking in the sentence hyperlink.

What this means for you:

The FDA has declared that it does not intend to take action against any company as long as 4 conditions are met inclujding the percentage of ingredients and labeling. We urge you to stay informed and read these two documents. The four conditions require a culture of quality and good supply process.

As always, you can read more about how we have successfully guided our clients through current and changing FDA Regulations, gap assessments, quality assessments, and warning letters for two decades. Your success is ours.

The Compliance Insight Team