Project Description

Importing PPE and EUA Goods

We detail everything you need to know on importing personal protective equipment (PPE) and/or goods for emergency use authorizations (EUA) .

What Do You Need to Know?

Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, there has been an increase personal protective equipment (such as masks and gowns) and swabs in relation to the COVID-19 pandemic and Emergency Use Authorizations (EUA).

We detail for both Canada and the USA how to import such items, details surrounding their HS Classifications, ensuring that you stay compliant with both Canada and U.S. Customs – below.

HS Classification Doc

World Customs Organization (WCO), and World Health Organization (WHO)

In light of the COVID-19 pandemic health crises, the World Customs Organization (WCO), and World Health Organization (WHO) worked together to create a more comprehensive, more user-freindly format of the HS classification for Covid-19 medical supplies.

Canada PPE/EUA (Health Canada)

Tariffs have been waived on certain medical goods, including PPE such as masks and gloves. This will reduce the cost of imported PPE for Canadian businesses, which face tariffs of up to 18% in some instances, help protect workers, and ensure supply chains can keep functioning well.

Description of these goods, their tariff codes, and other additional information can be found here.

Application

  • Commercial goods: to obtain relief of customs duties at time of import, special authorization code 20-304 is to be entered in field 26 – Special Authority of Form B3-3.
  • Casual goods: Form BSF715 or BSF715-1 Casual Goods Accounting Document, will be prepared according to standard procedures without collection of duty.

In response to the unprecedented need for personal protective equipment Health Canada has issued a notice on interim measures to better facilitate and expedite the application process for Health Canada Licenses.

Health Canada issues two types of licenses:

  1. Medical Device License (MDL): for the actual product itself
  2. Medical Device Establishment License (MDEL): for the organization or company importing or selling a device

There is no duty / tax on goods required for emergency goods that are imported for or by federal, provincial or municipal governments for health care, such as first responders and medical response teams that qualify under tariff 9993.00.00 of the Customs act.

At time of import, special authorization code 73-2529 is to be entered in field 26 and “9993” should be entered in field 28 of your Form B3-3.

CBSA is requesting that importers add the term ‘URGENT – COVID-19’ for goods description in release information submitted to the CBSA for all medical devices being imported to Canada for this purpose.

☑️ Medical Device License (MDL): for the actual product itself.

☑️ Medical Device Establishment License (MDEL): for the organization or company importing or selling a device.

Surgical Masks & N95 Masks

  • Class I
  • Importer is required to apply for a MDEL license
  • Approval on applications is 10 calendar days

Oxygen Masks, Gas Masks, Aerosol Administration Masks, etc.

  • Class II
  • The product itself needs to be approved as an MDL and the importer is required to apply for a MDEL
  • Approval on applications is 10 calendar days

General Purpose Masks, Home Cleaning Masks, Nail Salon Masks

  • Unregulated
  • No license requirements
  • Not approved for Healthcare use

Masks for Company’s Own Use

  • Exempt
  • Exempt from MDL / MDEL if the importer meets the definition per Guidance of Medical Device Licensing
  • Companies are considered the ultimate consumer* and these goods are only to be used by employees

*Ultimate Consumer: is the individual who purchases or receives a medical device for their own personal use (including use within their household) or receives treatment or diagnosis with a medical device from a health care facility or provider. Businesses that purchase medical devices solely for use by their employees during work activities (e.g. first aid kits, disposable gloves) or for incidental emergency use are also considered ultimate consumers, as long as they are not in the business of offering healthcare services to employees or other individuals.

Plastic Face Shields (covering more than the eye area)

  • Revised Classification – 3926.90.10.00 – Safety face shields designed for use by workers employed in hazardous work, and parts thereof; – (Revised CN 20-12)
  • Previous WCO Classification – 3926.20.10.00 – Protective suits and their accessories (including gloves), to be employed in a noxious atmosphere, of plastics. CSCB asked CBSA for clarification on the classification of plastic face shields – CBSA agreed a more appropriate classification is “Safety face shields of plastic, designed for use by workers employed in hazardous work” which are specifically named under” 3926.90.10.00.

​Textile material face masks manufactured in the China subject to duty and tax

  • ​6307.90.99.20 – Textile material face masks manufactured in the China are subject to a rate of duty of 18% as well as the goods and services tax at a rate of 5%.
  • 6307.90.10 00 – Respirators, NIOSH approved or equivalent, consisting of several layers of non-wovens of man-made fibres, whether or not treated with activated carbon, with or without an exhalation valve, to be employed in a noxious atmosphere. These goods are duty of free.

Note:

Importations may be subject to examination at the time of importation and to post-release verification for compliance with the Tariff Classification, Valuation, Origin and Marking programs, and any other applicable provisions administered by the CBSA.

Non-Medical Grade Masks

If importing non-medical grade masks, that do not meet the definition of a medical device, an MDEL is not required for your [company/individual use] as long as it is clear that your product is not medical use or advertised to protect against COVID-19. In addition, you would not need to make a request for an Interim Order for importation and sale of non-medical grade masks.

Best practice would be to ensure the shipment is clearly indicated /labelled “not for medical use” and be aware that these products will be subject to duty. If you would like more information about your import please contact: hc.hpbcp-pcpsf.sc@canada.ca

☑️ Medical Device License (MDL): for the actual product itself

☑️ Medical Device Establishment License (MDEL): for the organization or company importing or selling a device

Medical Gowns, surgical or isolation

  • Class I
  • Importer is required to apply for a MDEL
  • MDEL is not required when medical gowns are imported directly by a healthcare facility

Medical Gloves, for patient examination or surgical purposes

  • Class II
  • The product itself needs to be approved as an MDL and the importer is required to apply for a MDEL
  • MDEL is not required when medical gloves are imported directly by a healthcare facility

In order to import and sell a hand antiseptic in Canada, authorization from Health Canada is required. Hand Sanitizers are classified as either natural health products (NHP) or non-prescription drugs depending on what ingredients were used. Typically, a site license for the company and a product license for the goods are required.

Full details here ➡️ Expedited access to disinfectants, hand sanitizers and personal protective equipment to help limit the spread of COVID-19, as well as swabs for testing

For importation, Health Canada is permitting supplies that may not fully meet Canadian regulatory requirements including:

  1. English-only labelling
  2. Hand sanitizers that meet the NNHPD’s Antiseptic skin cleansers monograph requirements
  3. Hand sanitizers that have a DIN or NPN for personal commercial use or for a different dosage form
  4. Products that are not approved for sale in Canada but are approved or registered in the United States

In order to import or manufacture companies will require the following licenses:

  1. Product License: The Antiseptic Skin Cleansers monograph describes the necessary requirements and application process.
  2. Site License: Companies will need to email the Natural and Non-Prescription Health Products Directorate requesting access to the interim Site License process. Issuance will be expedited in 24-28 hours.

Companies will not need to submit a Quality Assurance Report or other forms of proof providing they follow Good Manufacturing Practices (GMP) inclusive of:

  • Part 3 of the Natural Health Products Regulations
  • Division 2 of the Food and Drug Regulations
  • Good Manufacturing Practices for Cosmetic Products
  • Guide to Food Safety

Note:

Health Canada is prioritizing COVID-19 related applications and companies will need to reference the Class I expedited process for hand sanitizers. Expect an immediate response and approval in 10 calendar days.

Diagnostic Test Kits, Face and Eye Protection, Gloves, Protective Garments and the Like, Disinfectants/Sterilization products, Medical Devices, Thermometers, Wipes, Medical Consumables, Other Products

  • All medical supply product HS Classifications and descriptions can be found here.

Note: CBSA is requesting that importers add the term ‘URGENT – COVID-19’ for goods description in release information submitted to the CBSA for all medical devices being imported to Canada for this purpose.

I.E. Canada Requests COVID-19 Committee to Extend Conditional Duty Relief on Certain articles of Personal Protection Equipment (PPE) to Support Front Line Workers of Essential Services.

I.E. Canada recognized that a lot of members would need to acquire PPE in order to continue operations or eventually ramp back up. They have identified that domestically there simply are not enough options and I.E. Canada members need to look abroad for solutions. The duty rates on non-medical PPE are as high as 18% (facemasks), and a reduction of this is being requested.

I.E. Canada is requesting that further consideration includes – Conditional Duty-Relief on goods identified to be extended to all deemed Essential Workers identified by Public Safety Canada as and Functions in Canada during the COVID-19 Pandemic.

Canadian businesses need this relief in order to provide protection to I.E. Canada’s deemed front-line essential services workers.

USA PPE/EUA (FDA)

We detail this new development on USITC’s COVID-19 Response Product Database Released; Democrats Call for Duty Suspension here.

Excerpt:

Chairman Richard Neal (D-MA) has called for 90-day suspension of all tariffs (duty) on products identified by the USITC and relevant to the COVID-19 pandemic response. He noted that such tariff suspensions “must be subject to a straightforward and easily administrable process for affected stakeholders to object.”

Currently roughly half of the HTS numbers are subject to punitive duty rates in the ongoing US-China trade war, with 39 headings subject to additional duties at 25% and 16 at the 7.5% rate, when the goods are imported from China.

Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA).

When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code.

Below is a list of products that are currently authorized by an EUA – full listing and product codes can be found here:

  • Non-NIOSH-Approved Respirators: 80QKU
  • NIOSH-Approved Respirators
  • Face Masks (Non-Surgical)
  • Diagnostic Tests Kits
  • Ventilators
  • Face Shields
  • Respirator Decontamination Systems
  • Extracorporeal Blood Purification Devices
  • Infusion Pumps
  • Ventilators
  • Diaphragmatic Pacing Simulator Systems

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

When importing such devices, entry information should be submitted to FDA.

At the time of entry, Importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.

Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which reference applicable product codes and policy for those products:

A full list of all guidance documents related to COVID-19 is also available on FDA’s website. For guidance applicable to medical devices, you may filter by the medical device product area and display all entries. Please check this site, as well as Information for Filing Personal Protective Equipment and Medical Devices During COVID-19, regularly for current information on these and other product areas.

There are many products marketed in the United States as “face masks” that offer a range of protection against potential health hazards. Face masks and respirators are regulated by FDA when they meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. Generally, face masks fall within this definition when they are intended for a medical purpose, including for use by health care professionals. Face masks that are not intended for a medical purpose are not medical devices, as described can be found here.

☑️ FDA REGULATED Masks

21 CFR 878.4040

  • Mask, Surgical – (Product Code: FXX)
  • Pediatric/Child Facemask – (Product Code: OXZ)
  • Surgical mask with antimicrobial/antiviral agent – (Product Code: OUK)
  • Respirator, Surgical – (Product Code: MSH)
  • N95 Respirator with Antimicrobial/Antiviral Agent – (Product Code: ONT)
  • Surgical Apparel Accessory (Face Shields) – (Product Code: LYU)

21 CFR 880.6260

  • N95 Respirator with Antimicrobial/Antiviral Agent for Use by the General Public in Public Health Medical Emergencies – (Product Code: ORW)
  • Respirator, N95, for Use by the General Public in Public Health Medical Emergencies – (Product Code: NZJ)

✖️FDA NON-REGULATED Masks

21 CFR 868.5450

  • Humidifier, Respiratory Mask – (Product Code: OBN)
  • Humidifier, Respiratory Gas – (Product Code: BTI)

21 CFR 868.5550

  • Mask, Anesthetic, Gas – (Product Code: BSJ)

21 CFR 868.5580

  • Mask, Oxygen – (Product Code: BYG)

21 CFR 868.5600

  • Mask, Oxygen, Low Concentration , Venturi – (Product Code: BYG)

21 CFR 868.5570

  • Mask, Oxygen, Non-Rebreathing – (Product Code: KGB)

21 CFR 868.5905

  • Resuscitator, Manual, on Self-Inflating – (Product Code: NHK)
  • ​Mask, Ventilator, on-Continuous, Reprocessed – (Product Code: MC)

21 CFR 868.5560

  • Strap, Head, Gas Mask – (Product Code: BTK)

Note:

Importations may be subject to examination at the time of importation and to post-release verification for compliance with the Tariff Classification, Valuation, Origin and Marking programs, and any other applicable provisions administered by the CBP.

Gowns/Apparel/Gloves, Personal Protective Equipment (PPE) for Medical Use

Gowns, other apparel, and gloves that are intended for a medical purpose, are considered medical devices. (diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease).

☑️ FDA REGULATED Gowns and Other Apparel

21 CFR 878.4040 

Device Type – Product Code – Class Type (detailed in that order below)

  • Conductive Shoe and Shoe Cover – BWP – I (exempt)
  • Operating-Room Shoes – FXW – I (exempt)
  • Surgical Apparel Accessory – LYU – I (exempt)
  • Non-surgical isolation gowns – OEA – I (exempt)
  • Surgical suits – FXO – I (exempt)
  • Operating-room shoe covers – FXP – I (exempt)
  • Surgical helmets – FXZ – I (exempt)
  • Surgical dress – FYE – I (exemot)
  • Surgical caps – FYF – l (exempt)
  • Surgical gown/toga – FYA – II
  • Patient gown – FYB – II
  • Sunrical isolation gown – FYC – II
  • Surgical hood – FXY – II

☑️ FDA REGULATED Gloves

21 CFR 880.6250 

Device Type – Product Code – Class Type (detailed in that order below)

  • Patient Examination Glove – FMC – I (reserved)
  • Latex Patient Examination Glove – LYY – I (reserved)
  • Polymer Patient Examination Glove – LZA – I (reserved)
  • Finger Cot – LZB – I (exempt)
  • Vinyl Patient Examination Glove – LYZ – I (reserved)
  • Powder-Free Guayle Rubber Examination Glove – OIG – I (reserved)
  • Powder-Free Polychloroprene Patient Examination Glove – OPC – I (reserved)
  • Radiation Attenuatiug Medical Glove – OPH – I (reserved)
  • Specialty Patient Examination Glove – LZC – I (reserved)

21 CFR 880.4460 

Device Type – Product Code – Class Type (detailed in that order below)

  • Surgeon’s Gloves – KGO – I (reserved)
  • Powder-Free Non-natural Rubber Latex Surgeon’s Gloves – OPA – I (reserved)

✖️FDA NON-REGULATED

Gowns, other apparel, and gloves that are NOT intended and marketed for a medical purpose, are not medical devices. 

  • Are they intended for general or industrial use? If YES, then they are NOT FDA regulated.

☑️ FDA REGULATED Ventilators

Classification – Device Type – Product Code – Class Type (detailed in that order below)

  • 21 CFR 868.5895 – Ventilator, Continuous, Facility Use – CBK – II
  • 21 CFR 868.5895 – Ventilator, Continuous, Minimal Ventilator Support. Facility Use – MNT – II
  • 21 CFR 868.5895 – Continuous, ventilator, home use – NOU – II
  • 21 CFR 868.5895 – Ventilator, continuous, minimal ventilatory support, home use – NQY- II
  • 21 CFR 868.5895 – Ventilator, continuous, non-life-supporting – MNS – II
  • 21 CFR 868.5895 – Mechanical Ventilator – ONZ – ll
  • 21 CFR 868.5925 – Ventilator, Emergency, Powered (Resuscitator ) – BTL – II
  • 21 CFR 868.5160 – Gas-machine, anesthesia – BSZ – II
  • 21 CFR 868.5905 – Ventilator, non-continuous (respirator) [ncluding masks4 and interfaces under the same product code – BZD – II
  • 21 CFR 868.5905 – Conserver, Oxvgen – NFB – II
  • 21 CFR 868.5905- Device, Positive Pressure Breathing , lntemmittent – NHJ – II
  • 21 CFR 868.5905 – Resuscitator , Manual, Non Self-Inflating – NHK – II
  • 21 CFR 868.5454 – High flow/high velocity humidified owygen delivery device – QAV – I

☑️ FDA REGULATED Respiratory Devices and/or Accessories

Classification – Device Type – Product Code – Class Type (detailed in that order below)

  • 21 CFR 868.5240 – Anesthesia breathing circuit OFP I Anesthesia breathing circuit – CAI – I
  • 21 CFR 868.5260 – Filter Bacterial, Breathing-Circuit – CAH – I
  • 21 CFR 868.5270 – Heated breathing circuit – BZE – I
  • 21 CFR 868.5340 – Cannula, Nasal, Oxygen – CAT – I
  • 21 CFR 868.5440 – Generator, oxygen, portable – CAW – II
  • 21 CFR 868.5450 – Humidifier, Respiratory Gas,(Direct Patient Interface) – BTT – II
  • 21 CFR 868.5580 – Mask. Oxvgen – BYG – I
  • 21 CFR 868.5730 – Tube, Tracheal (W/Wo Connector) BTR 11 Airway Monitoring System -OQU – II
  • 21 CFR 868.5895 – Accessory to Continuous Ventilator (Respoirator) – MOD – II
  • 21 CFR 868.5965 – Attachment, Breathing, Positive End Expiratory Pressure – BYE – Il
  • 21 CFR 868.5975 – Set, Tubing, and Support, Ventilator – BZO – Il

✖️FDA NON-REGULATED Ventilator Devices

Wherever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators to treat patients who develop respiratory failure or respiratory insufficiency. However, to support the wider availability of devices for patients in need of ventilatory support in the United States for the duration of the public health emergency, FDA is interested in interacting with manufacturers of ventilatory support devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been engaged in medical device manufacturing with capabilities to increase supply of these devices. FDA will work interactively with these manufacturers through its Emergency Use Authorization (EUA) process.

FDA would find it helpful if such manufacturers (whether foreign or domestic) send FDA the following information to this email.

FDA believes this information will be valuable in assessing whether the device would be able to meet the EUA requirements. FDA believes that companies may already have available information to help support an EUA request for ventilators, such as the information outlined below. FDA will expeditiously review this information, and other required information, to determine if an EUA can be issued.

This policy described in this guidance applies to the following non-invasive remote monitoring devices that measure or detect common physiological parameters and that are used to support patient monitoring during the COVID-19 public health emergency:

These non-invasive monitoring devices have the potential to be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection to transmit a patient’s measurements directly to their health care provider or other monitoring entity. Some of these devices also have the potential to apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a health care professional in the diagnosis of a particular condition or disease state/severity.

☑️ FDA REGULATED Non-Invasive Remote Monitoring Devices

Classification – Device Type – Product Code – (detailed in that order below)

  • 21 CFR 880.2910 – Clinical electronic  thermometer – FLL
  • 21 CFR 870.2340 – Electrocardiograph (ECG) – DPS
  • 21 CFR 870.2300 – Cardiac monitor – ORT, MW1, MSX, PLB
  • 21 CFR 870.2345 – Electrocardiograph software for over-the-counter use – QDA
  • 21 CFR 870.2700 – Pulse Oximetry (SpO2) – DQA
  • 21 CFR 870.1130 – Non-invasive Blood Pressure (NTBP) – DXN
  • 21 CFR 868.2375 – Respiratory Rate/Breathing Frequency – BZQ
  • 21 CFR 870.1875 – Electronic Stethoscope – DOD
On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to this public health emergency. This guidance was updated on March 16, 2020.

CDC has granted a right of reference to the performance data contained in CDC’s EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

The templates for these EUA submissions are available:

This guidance applies to devices that already have FDA marketing authorization, as well as devices that are not currently marketed but would fall under one of the classification regulations provided below.

Sterilizers for use in a health care facility are medical devices that are regulated by FDA and are intended to render medical devices sterile (i.e., free from viable microorganisms). Sterilizers vary in both construction (ranging from small table-top sterilizers to large sterilizers intended for large loads) and modality (e.g., steam, ethylene oxide, vaporized hydrogen peroxide, etc.). FDA evaluates and authorizes sterilizers for marketing with specific cycle parameters intended for specific loads and with their own sterilization accessories (e.g., biological indicators, chemical indicators, wraps, trays,etc)

☑️ FDA REGULATED Sterilizers

Classification – Device Type – Product Code – Class Type (detailed in that order below)

21 CFR 872.6730 – Endodontic dry heat sterilizer – KOK – III
21 CFR 872.6730 – Glass bead sterilizer – ECC – III
21 CFR 880.6100 – Ethylene-oxide (EO) gas aerator cabinet – FLI- II
21 CFR 880.6860 – Chemical Sterilizer – MLR – II
21 CFR 880.6860 – Two or more sterilant sterilizer – PJJ – II
21 CFR 880.6860 – EO gas sterilizer – FLF – II
21 CFR 880.6870 – Dry heat sterilizer – KMH – II
21 CFR 880.6880 – Steam sterilizer – FLE – II
21 CFR 880.6880 – Sterilizer automated loading svstem – PEC – II

For the purposes of this guidance, FDA considers chemical/physical disinfectant devices to encompass chemical disinfectant solutions used to disinfect medical devices, as well as medical washer disinfectors or automated endoscope reprocessors (AERs) that utilize chemical disinfectant solutions or physical (e.g., thermal) processes to reprocess for medical devices.

☑️ FDA REGULATED

Chemical/Physical Disinfectant Devices

Classification – Device Type – Product Code – (Class Type (detailed in that order below)

  • 21 CFR 876.1500 – Cleaning accessories for endoscope – FEB – II
  • 21 CFR 880.6885 – Medical devices sterilient – MED – II
  • 21 CFR 880.6992 – Medical devices disinfectors – MEC – II (exempt from premarket review unless indicated for high level disinfection or for use on endoscopes and accessories)
  • 21 CFR 880.6992 – Medical devices cleaners – MDZ – II
  • 21 CFR 892.1570 – High level disinfection reprocessing instrument for ultrasonic transducers, mist – OUJ – II
  • 21 CFR 892.1570 – High level disinfection reprocessing instrument for ultrasonic transducers, liquid – PSW – II

Ultraviolet (UV) Disinfecting/Devices UV disinfecting devices

Are devices that use UVA or UVC light to produce a germicidal effect. They are intended to augment disinfection of health care environmental surfaces after manual cleaning has been performed. UV disinfecting devices include UV radiation chamber disinfection devices, which are regulated as Class II devices under 21 CFR 880.6600 (product code OSZ.

Air Purifiers/Air purifying devices are intended for medical purposes to kill pathogens/microorganisms in the air by exposure to UV radiation or remove them through filtration. The classification regulations and associated product codes for air purifying devices, to which the policy in this guidance applies below.

☑️ FDA REGULATED Air Purifiers

Classification – Device Type – Product Code – Class Type (detailed in that order below)

  • 21 CFR 880.5045 – Medical recirculation air cleaner – FRF – II
  • 21 CFR 880.6500 – Medical UV air purifier FRA – II

The enforcement policy in this guidance applies to clinical electronic thermometers, which are regulated as Class II devices under 21 CFR 880.2910, product code FLL. These devices include both contact and non-contact clinical electronic thermometers.

Manufacturers of clinical electronic thermometers are required to submit a premarket notification to FDA and receive FDA clearance prior to marketing these devices in the United States, as well as comply with post-marketing requirements.

Hand Sanitizer is always considered a drug by FDA standards if it contains an active ingredient. Typically hand sanitizer contains alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride – which are all considered to be active ingredients.

FDA still requires the following information to be transmitted at the time of entry:

  • FDA Drug Listing Number (Formerly NDC Number), for the drug product being shipped
  • FDA Drug Registration Number (DUNS Number)
  • FDA Manufacturer’s full name, address and listing number #
  • Copy of the labels
  • Copy of the list of ingredients
  • Any safety hazard analysis information provided by the manufacturer
  • FDA also requires the manufacturer to list all known Importer / Consignee under their drug registration

Filing Entries of Hand Sanitizer

CSMS #42590577 clarifies the FDA’s expectations regarding filing entries of hand sanitizers.

Some entries of hand sanitizers are being 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 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.”

FDA says that recent guidance by the agency in relation to COVID-19 does 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.”

Tips to help filers with their entries can be found below.The product code is determined according to the hand sanitizer’s active ingredient.  For example:

Active Ingredient in OTC Hand Sanitizer – FDA Product Code (in that order)

  • 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”.

Any questions or concerns regarding this message should be addressed sent the FDA here.

Certain scarce personal protective equipment (PPE) materials identified by the Federal Emergency Management Agency’s (FEMA) Temporary Final Rule (TFR) which are exempt from the ban on exportation from the U.S., that went into effect on April 10, are:

  • N-95 Filtering Facepiece Respirators,
  • Other Filtering Facepiece Respirators (N99, N100, R95, R99, R100, or P95, P99, P100),
  • Elastomeric, air-purifying respirators and appropriate particulate filters/cartridges;
  • PPE surgical masks,
  • PPE gloves or surgical gloves

According to CBP, any exported materials covered in the list above that belong to one or more of the ten exemptions described may proceed immediately for export as scheduled. Please refer to the CSMS for the full list of exemptions here.

CBP states that in order to qualify for some of the exemptions, FEMA requires a letter of attestation. For these exemptions, the exporter, shipper or their agents should present the letter via DIS, on company letterhead, signed by a responsible company official, including:

  • a description of which exemption(s) the exporter is claiming;
  • details regarding the shipment that are sufficient for the CBP and FEMA officials to determine whether the shipment falls under the claimed exemption(s), including the required information identified in the Federal Register notice published on April 21, 2020;
  • a statement that the provided information is true and accurate to the best of the exporter’s knowledge, and that the exporter is aware that false information is subject to prosecution under the DPA, as outlined in the allocation order.

In order to avoid detention of shipments, letters should be uploaded in DIS at the same time as the Electronic Export Information (EEI) is transmitted in the Automated Export System (AES).

We Can Assist with Your PPE/EUA Imports – Chat with a GHY Import Specialist Today!

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