Customs Updates: Filing Entries of Hand Sanitizers for FDA

The U.S. Food and Drug Administration (FDA) has clarified its expectations regarding the filing of entries of hand sanitizers.

FDA has recently become aware that some entries of hand sanitizers have been disclaimed to FDA, and the full message set was not filed for FDA review. Additionally, its aware that some entries of hand sanitizers have been transmitted as cosmetics instead of drugs.

Hand sanitizers are drugs regulated by the FDA and are generally considered as over-the-counter (OTC) drug products. Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act, and the pertinent regulations are found in Title 21 of the Code of Federal Regulations (21 CFR).  As such, entries of hand sanitizers are required to be filed with the FDA upon importation with the appropriate PG Message set data for OTC drug products. Importers/entry filers should not disclaim entries of hand sanitizers.

Regarding the COVID-19 public health emergency, the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) do not affect the requirement to file entries of hand sanitizers with the FDA, or the product specific requirements verified by FDA at the time of entry.

As described in the temporary policies, foreign manufacturers whose drugs, including over-the-counter drugs, that are imported into the United States are required to register with FDA and submit a listing of drugs in commercial distribution, before the drugs are imported (as required by section 510 of the FD&C Act and 21 CFR Part 207).

For more information on the drug importation process, please see: https://www.fda.gov/industry/regulated-products/human-drugs.

Tips to Help Entry Submission:

The FDA product code is determined according to the hand sanitizer’s active ingredient.  For example:

Active Ingredient in OTC Hand Sanitizer. FDA Product Code

Ethyl Alcohol 62HAL05

Isopropyl Alcohol 62FAL23

Benzalkonium Chloride. 62HAL99

ACE requirements for the electronic transmission of drug products to FDA can be found in the FDA Supplemental Guide beginning on page 79.  OTC drug products are transmitted using PG-01 Government Agency Program Code “DRU” and PG-01 Government Agency Processing Code “OTC”.

Information Provided by U.S. Customs and Border Protection.

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