US FDA Registration-Hand Sanitizer
As an antimicrobial product for human hand use, hand sanitizer is classified as an over-the-counter (OTC) topical antiseptic product in the United States and is regulated by the Food and Drug Administration (FDA). Compliance requirements are quite different from environmental disinfectants regulated by Environment Protection Agency (EPA). The main regulation is FFDCA (Federal Food, Drug, and Cosmetic Act).
Generally speaking, there are two ways for over-the-counter drugs to be marketed in the United States.
- New drug application (NDA), which need to submit an application for FDA approval.
- Marketed under the OTC Monograph.
OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. No FDA pre-approval needed for OTC dugs marketed under the OTC monograph.
For hand sanitizer, enterprises can produce products according to the requirements of OTC monographs, and then placing the products on US market directly without FDA pre-approval.
Corporate obligations and compliance strategies
For hand sanitizer, only three active ingredients–alcohol (ethanol), isopropyl alcohol, and benzalkonium chloride–are currently available through the OTC monograph non-approval pathway.
- The OTC monograph of hand sanitizer requires that the active ingredients should be alcohol, isopropyl alcohol and benzalkonium chloride. The content should also meet certain requirements: alcohol-based hand sanitizer that contains at least 60% ethanol; isopropyl alcohol -based hand sanitizer that contains at least 70% ethanol.
- Inactive ingredient must use substances in FDA inactive ingredient database.
- The manufacturing Establishment must meet the requirements of Current Good Manufacturing Practice (cGMP).
- The labels of hand sanitizer must conform to the corresponding labeling regulations.
On the basis that hand sanitizer meets the requirements of OTC monograph, following compliance work need to be done before placing hand sanitizers on the market.
- Apply for DUNS numbers for related manufacturers and traders.
- Register the Manufacturing Establishment with FDA.
- Apply for National Drug Number (NDC) for the target product.
- Product listing(s) with FDA
- Update manufacturing Establishment and product information every year.
For companies outside the United States, an agent in the United States is required to fulfill these compliance obligations.
Who can register
In addition to manufacturers of hand sanitizer, downstream traders, importers and distributors can also listing a product with FDA.
- FDA Establishment registration
- NDC application
- Label reviewing
- Hand sanitizer listing
- Hand sanitizer updating and re-registration
- Deep experience: professional tracking of FDA hand sanitizer regulation for many years.
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