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FAQ: Importing Hand Sanitizer

Home News FAQ: Importing Hand Sanitizer

Below is information from the Food and Drug Administration (FDA) regarding the importation of hand sanitizer. 

The import process and admissibility requirements for OTC drug products, such as hand sanitizer, have not changed due to the COVID-19 pandemic.Currently there are no regulatory exemptions for imported hand sanitizers. To assist you, I am including general information about the applicable laws and regulations affecting the importation of drug products including hand sanitizer for further distribution in the United States.

IS MY HAND SANITIZER AN OTC DRUG PRODUCT?

For OTC drug products intended for use as consumer antiseptic rubs, on April 12, 2019, FDA published the Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use Final Rule (84 FR 14847) (effective April 12, 2020). FDA deferred consideration of benzalkonium chloride, ethyl alcohol, and isopropyl alcohol as the active ingredient in the antiseptic rub in this rule to allow for the ongoing study and submission of additional safety and effectiveness data (for additional information, see Docket No. FDA–2016–N–0124 at https://wwwregulations.gov).

Until FDA promulgates final rules establishing whether one of the three deferred ingredients listed in the rule above, is generally recognized as safe and effective (GRASE) for the antiseptic uses described above, the agency generally does not intend to object to the marketing of products, provided they meet the proposed formulation and labeling conditions described in the relevant tentative final monograph (TFM) or are similarly formulated and labeled as a product that was marketed at or before the inception of the OTC Drug Review (on or before December 4, 1975) and each general condition in 21 CFR 330.1 and provided that a particular product does not constitute a hazard to health (see 68 FR 75590, December 31, 2003 and 79 FR 10168, Feb 24, 2014). Such marketing is subject to the risk that a final rule may require reformulation, relabeling, and/or FDA approval under section 505 of the FD&C Act, 21 U.S.C. § 355.

IF YOUR HAND SANITIZER DOES NOT MEET THE ABOVE REQUIREMENTS, IT IS MOST LIKELY A DRUG PRODUCT THAT WILL NEED AN APPROVED DRUG APPLICATION (NDA/ANDA):

Drugs products imported or offered for import into the USA must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (the Act) and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR). These requirements include approval of drugs prior to marketing in the United States, i.e., through submission of new drug applications (NDAs) or abbreviated NDAs (ANDAs), proper labeling, establishment registration and drug listing, and manufacturing in accordance with current Good Manufacturing Practice (CGMP) requirements.

For prescription (Rx) and non-prescription or over-the-counter (OTC) drugs that require NDA or ANDA approval, the NDA or ANDA must be filed with and approved by the Center for Drug Evaluation and Research (CDER) prior to the importation of such product as required by section 505(a) of the Act and 21 CFR 314.

A description of the NDA/ANDA process can be found on FDA’s Internet Web site. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Human Drug Information, Division of Drug Information, Center for Drug Evaluation and Research, WO51-2201, 10903 New Hampshire Avenue, Silver Spring, MD 20993.

DRUG LABELING REQUIREMENTS FOR BOTH OTC DRUG PRODUCTS AND DRUG PRODUCTS WITH APPROVED APPLICATIONS: All drug products must comply with the labeling requirements under Section 502 of the Act and 21 CFR Part 201 et al.

FOREIGN DRUG MANUFACTURER’S DRUG ESTABLISHMENT REGISTRATION AND DRUG PRODUCT LISTING REQUIREMENTS FOR OTC AND NDA/ANDA DRUG PRODUCTS:

Foreign manufacturers whose drugs are imported or offered for import into the U.S. are required to register with FDA and submit a listing of every product in commercial distribution in the U.S. as required by Section 510 of the Act and 21 CFR 207. These requirements apply to all manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing or testing of human or veterinary drugs and human biological products, including the manufacturer of active pharmaceutical ingredients. Drug products must be listed with FDA before they may be imported for commercial distribution in the U.S., and the foreign manufacturer is required to register with FDA within 5 days of the submission of a NDA or an ANDA. In addition, these regulations require importers to identify a U.S. Agent. Foreign establishments required to register with FDA must list all known importers in their drug registration in accordance with 21 CFR 207.25(h)(2). The necessary registration and listing forms can be found on FDA’s Internet web site. Please note that registration of a drug establishment or drug wholesaler, or assignment of a registration number, or drug listing, or assignment of a NDC number does not in any way denote approval of the firm or its products (see 21 CFR 207.39).

This is not intended to be an all-inclusive list of the requirements of the Act and regulations applicable to the importation of drug products. Due to the agency’s limited resources, we are unable to provide extensive consultative services. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Act and regulations. Should you have further questions concerning the manufacturing, labeling, approval requirements, etc. of any drug products you are interested in importing into the US, we recommend that you retain the services of an attorney or consultant with expertise regarding the Act and its implementing regulations.

General information on importing drug products:

  1. Ensure your product was manufactured according to U.S. Good Manufacturing Practices and that it is not contaminated, adulterated, misbranded, or otherwise does not meet U.S. laws and regulations.
  2. Ensure the product is an OTC drug product or if an NDA/ANDA product then is covered by the appropriate approved and/or active application.
  3. Ensure the labeling meets U.S. requirements.  Also see 21 CFR 201.
  4. Ensure the required firms are registered and have listed their product(s). Also ensure the importer is a “known importer” listed in the manufacturer’s registration.
  5. Ensure the product is not subject to an Import Alert.
  6. When it is time to file a Customs Entry, you may consider using a Customs Broker

 

Source: Food and Drug Administration

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