FDA tightens up rules for hand sanitizer manufacturers

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The US Food and Drug Administration said on Tuesday companies manufacturing certain alcohol-based hand sanitizers under its previous relaxed guidance must stop making these products by the end of the year as there is no longer a shortage.

The FDA had issued the temporary guidelines in March 2020 to address tight supply conditions for sanitizers, driven by a surge in demand for the products during the coronavirus outbreak.

On Tuesday, the agency withdrew the guidance and said companies that have been manufacturing the sanitizers under the temporary guidelines should stop making the products effective Dec. 31.

“In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and health-care personnel are no longer having difficulty obtaining these products,” the agency said.

Hand sanitizers manufactured before Dec. 31 or on that date and produced under the previous temporary guidelines must no longer be sold to wholesalers or retailers by March 31, 2022, the agency added.

The FDA said manufacturers that wish to continue making hand sanitizers after Dec. 31 must comply with the agency’s manufacturing requirements.

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