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How FDA Regulates Hand Sanitizers

fda hand sanitizer

FDA regulates hand sanitizers (antiseptic hand wash products) as over the counter (OTC) drug products. They are drug products because they are used to prevent disease. Therefore, hand sanitizer products must comply with FDA’s drug regulations.
To market hand sanitizers in the US, the following requirements must be met:

Establishment Registration

Any establishment that manufactures, repacks, or relabels the hand sanitizer must be registered with FDA as a drug establishment. Companies that only import the hand sanitizers (do not manufacture, repack, or relabel the product) do not need to register with FDA. For importing the hand sanitizer, the Customs filer/broker must declare the company’s registration number to FDA when filing the entry.

Drug Listing

Registered drug establishments must list the drug e.g. hand sanitizer with FDA. Each listed drug is assigned a National Drug Code (NDC). For importing a drug, the Customs filer/broker must declare the NDC number when filing the entry.

Drug Good Manufacturing Practices (GMPs)

Drugs including hand sanitizers must be manufactured and packed under FDA’s drug Good Manufacturing Practices (GMPs). The GMPs cover the design, monitoring, and control of the manufacturer’s facility and processes to ensure the products meet requirements for identity, strength, quality, and purity.

FDA OTC Drug Monograph Requirements

The hand sanitizer product must meet FDA’s OTC drug monograph requirements including formulation requirements.

Labeling Compliance

The labels of hand sanitizers must comply with all of FDA’s drug labeling requirements which include having a properly declared statement of identity, net quantity of contents, name and place of business (manufacturer, packer, or distributor), expiration date, and a Drug Facts panel which states the active ingredient(s), uses, warnings, inactive ingredients, purpose, directions, and contact information.

Note: Due to the COVID-19 public health emergency, FDA has established a temporary policy under which the agency will not take enforcement action against companies that manufacture or compound alcohol-based hand sanitizers if they comply with certain requirements which include drug labeling requirements, establishment registration, and drug listing. In addition, this policy only applies to products that contain certain USP grade ingredients in certain concentrations and which do not contain any other active or inactive ingredients.
Please let FDA Specialist know how we can assist you in complying with FDA’s regulations for marketing or importing hand sanitizers in the US!

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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