Hand Sanitizer FDA Registration & Approval
Hand Sanitizer is considered as over the counter drug (OTC) as per US FDA regulation. So manufacturing, import or distribution is permitted only after Hand Sanitizer FDA Registration and Listing. More information about FDA registration and listing detailed below.
Hand Wash / Hand Sanitizer FDA Registration Process
Step I : Manufacturing / Brand Owner Establishment Registration
- Active Drug Ingredients should be in OTC Monograph.
- Manufacturing process must comply with cGMP requirements.
- DUNS number is a must to initiate the process.
Step 2 : NDC Labeler Code
Step 3 : Label Compliance
It is the responsibility of the manufacturer that Hand Sanitizer / Hand Wash / Hand Gel / Hand Wipe primary information / label must comply with FDA regulation.
Step 4: Drug Listing
Drugs Labels must be submitted to FDA during the time of Drug Listing.
Hand Sanitizer / Wash / Gel Registration fees and Timeline
- US Agent Service + Establishment registration + NDC request = $ 649 [6-10 working days]
- Drug listing $ 399/Drug [6-10 working days] Change in BRAND, Change in FORMULA is considered as separate drugs)
- Label Review $ 650 to $ 950/Drug [ 14-20 working days]
- Guidance Fees $ 649 – $ 849 (DUNS Validation, Active Ingredient Verification, General Guidance & Application Processing)
- GMP Implementation Support
What is DUNS number? Is it mandatory for FDA Drug Establishment Registration?
DUNS is mandatory for Manufacturer and Brand Owner.
Importing Hand Sanitizer / Hand Wash / Hand Gel from any country what all I should take care?
- Manufacturer must have registered with FDA and listed each of the OTC drugs ( Hand Sanitizer / Hand Wash / Hand Gel) .
- US Importer is only a distributor original manufacturer Registration and listing is sufficient.
- Incase the US Importer is also the BRAND OWNER, the Brand Owner also must complete the FDA Registration & Listing.
- Make sure the OTC Drug Label complies with FDA guidelines.
What is considered as Hand Wash?
- Benzethonium chloride
- Benzalkonium chloride
Generally all Hand Wash products with above ingredients called Antiseptic wash products or called as antibacterial soaps. Such products are used along with water and used.
What is considered as Hand Sanitizers, Hand Gel & Hand Wipes
- Ethyl Alcohol
- Isopropyl alcohol
- Benzalkonium chloride
Hand Sanitizers are generally applied over the skin directly.
Hand Gel, Hand Wipes & Hand Sanitizer FDA Registration can be completed only after issue of NDC Number from FDA?
How can I verify FDA Registration of my company?
FDA registration & Listing required for Importer or Distributor?
Only Manufacturer and Brand Owner required to be registered with FDA. ( No matter which country the manufacturer or brand owner located.