The FDA (Food and Drug Administration) regulates hand sanitizers to ensure they are safe and effective for consumer use even though it is considered as cosmetics in some foreign countries.
The FDA recognizes ethanol or ethyl alcohol (60% to 95 %) and isopropyl alcohol (70% to 91.3 %) as safe and effective to be used as an active ingredient in hand sanitizers. Benzalkonium chloride is another active ingredient considered safe and effective, though less effective than alcohol-based sanitizers against certain germs.
FDA consider hand sanitizers as OTC drugs and must comply with below requirements.
- Register the manufacturing establishment with FDA.
- Submit labeler code request to FDA for the establishment.
- Submit drug listing with unique 10-digit NDC number for each hand sanitizer after FDA assign labeler code to the company.
- Label Compliance – Antiseptic hand sanitizer must have “Drug Facts” labeling and all other required information like usage, directions, and warnings.
- Comply with GMP Requirements as per 21 CFR 211 – Hand Sanitizer GMP which requires testing to ensure that the products are free from contamination and impurities.
Manufacturers that continue to make hand sanitizer products as of December 31, 2024, will be identified as OTC monograph drug facilities and be subject to an OMUFA facility fee for FY 2025 whereas if a company stopped the manufacturing process of hand sanitizers and deregister and de-lists their products before December 31st ,2024 will not be subject to FY 2025 OMUFA fee.
Liberty Management Group provides assistance with drug establishment registration, drug listing and label review and US agent service to foreign drug companies.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us
www.fdahelp.us