private label hand sanitizer manufacturer low moq

Does my hand sanitizer manufacturer need to be FDA registered?

By Blake Mereby · Last reviewed August 8, 2026

Yes. Hand sanitizer is classified as an OTC drug in the United States under FDA 21 CFR Part 211. Your co-packer must be an FDA-registered drug manufacturing facility operating under cGMP. Always request the facility's FDA registration number and verify it in the FDA's online drug establishment database before signing a contract.

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