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FDA Changes Sanitizer Rule to Address Supply Glut

The FDA's all-hands-on-deck approach to hand sanitizer production is over.

In spring of 2020, the FDA took an all-hands-on-deck approach to facilitating the production of hand sanitizer.

In short supply at the time, the agency permitted manufacturers who weren’t approved drugmakers to make alcohol-based sanitizer.

In the spring of 2021, reports began to emerge suggesting hand sanitizer was no longer in short supply. In fact, there was actually a surplus.

This week, the FDA announced that it would be withdrawing the temporary guidance on hand sanitizer it had issued last year.

The agency said those permitted to produce it temporarily must cease doing so by the end of the year, unless they update their operations to comply with applicable requirements.

Says the FDA, “We have determined it’s appropriate to withdraw the temporary guidances and are providing manufacturers time to adjust their business plans.”

In April, USA Today reported that “off-brand” hand sanitizer had flooded the market to the point where retailers were steeply discounting or even giving it away.

They added that established brands like Purell were still faring well, and that their demand remained at pre-pandemic levels.

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