FDA Hand Sanitizer Regulations
In the US, FDA regulates antiseptic hand sanitizers as OTC Monograph Drugs — requiring drug establishment registration, NDC labeler code, drug listing, and Drug Facts labeling.
Hand Sanitizer Regulations
Hand sanitizer regulations vary with each country; in the US, FDA regulate antiseptic hand sanitizer as an OTC Monograph Drug. In most other countries, Hand sanitizer comes under cosmetic regulations which require labeling compliance and complying with ISO 22716:2007- Good Manufacturing Practice for cosmetics.
FDA Regulations for Hand Sanitizer
FDA regulations for hand sanitizer is same as all other OTC Monograph drugs. The FDA requirements are
1. US FDA Registration – Register the manufacturing establishment with FDA.
2. NDC Labeler code – Request a labeler code for the establishment or Company.
3. Hand sanitizer listing with FDA – Assign a unique 10-digit NDC number and list each hand sanitizer with the FDA.
4. Label Compliance – Antiseptic hand sanitizer must have “Drug Facts” labeling and all other required information.
5. Comply with GMP Requirements as per 21 CFR 211 – Hand Sanitizer GMP
6. Comply with OTC Monograph – The eligible active ingredients in the OTC Monograph are Benzalkonium chloride, Ethyl alcohol or Ethanol ( 60 to 95 percent), and Isopropyl alcohol (70 to 91.3 percent)
Hand Sanitizer GMP
Current Good Manufacturing Practice, commonly known as GMP is the guidelines developed by US FDA to provide guidance to Drug, medical device, cosmetic and food manufacturers to assure the quality of their product. GMP compliance is a mandatory requirement for hand sanitizer.
Antiseptic hand sanitizer comes under drug regulations and have to follow drug GMP described in section 210 and 211 of title 21 in Code of Federal Regulations. It is worthwhile to get an external help to assess the level of GMP compliance and find the GAP in GMP implementation, even though FDA does not recommend a third party GMP audit or GMP certification.
Certificate of FDA Registration – Hand Sanitizer
LMG assist foreign and domestic hand sanitizer manufacturers to register with FDA , we also provide drug listing service and US FDA Agent service to foreign drug establishments. Please complete our online form to register your establishment with FDA.
Frequently Asked Questions
Do hand sanitizer manufacturers need FDA registration?
What labeling is required for hand sanitizers?
When must hand sanitizer registration be renewed?
Need Help with Hand Sanitizer Registration?
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