Hand Sanitizer Import Requirements — FDA

Foreign hand sanitizer manufacturers exporting to the USA must comply with FDA OTC drug regulations — including drug establishment registration, NDC labeler code, drug listing, and Drug Facts labeling.

OTC Drug ImportDrug Facts RequiredNDC Labeler CodeSince 2009

Hand Sanitizer Import Requirements – FDA Regulations

The FDA regulates hand sanitizers as OTC monograph drugs, so the product and everyone in its supply chain must meet FDA drug requirements. The contract manufacturer must complete drug establishment registration, list the drugs it manufactures, and follow CGMP; the PLD obtains its own labeler code and files the drug listing under its brand; and the imported product must be properly labeled and free of adulteration or misbranding. A distributor that resells a finished product is generally responsible for ensuring the product it imports is already compliant, rather than holding its own registration or listing.

FDA Import Requirements for Hand Sanitizer

Antiseptic hand sanitizer is classified as an OTC drug by FDA — not a cosmetic. Foreign hand sanitizer manufacturers exporting to the United States must comply with full FDA OTC drug requirements before their products can enter the country.

Products that do not meet FDA requirements may be detained at US ports of entry and refused admission.

Key import requirements for hand sanitizer include:

FDA Drug Establishment Registration — the foreign manufacturing facility must be registered with the FDA.
NDC Labeler Code — required for all hand sanitizer listings.
Drug Listing — each hand sanitizer product must be listed with the FDA in SPL format.
Drug Facts Labeling — must appear on the product label in the required format.
GMP Compliance — manufacturing must comply with 21 CFR Parts 210 & 211.
US FDA Agent — mandatory for all foreign drug establishments.