04/19/2020
During this impossible time, Big Apple is still working to insure our clients cargo moves timely and efficiently. We are fully equipped to help our clients import COVID-19 supplies such as masks and hand sanitizers. Below are the links to guidelines for FDA entry of COVID-19 merchandise:
Masks:
Unless the masks are medical devices, meaning labeled or marketed for a medical use, general purpose masks are not regulated by FDA - this includes N95 masks. General purpose masks are not regulated by FDA, so there is no registration or listing for FDA required for their importation. Because they are not regulated by FDA, entry information should not be transmitted to FDA for the entry of general purpose masks (including NIOSH-approved N95 respirators).
At the time of import, these non-medical masks would not be declared as FDA-regulated products; your entry filer should transmit using an appropriate HTS code with no FD Flag; or use an appropriate HTS code with an FD1 flag and do a disclaim for FDA.
If the face mask meets FDA regulations:
ACE Transmission Requirements
The data elements required to transmit a medical device in ACE can be found starting on page 217 of the FDA Supplemental Guide.
Program Code: DEV
Processing Code: NED
Intended Use Code: 081.001 Standard Device Import from a foreign manufacturer FDA Supplemental Guide
Product Code: face mask dependent
Registration and listing are required for all medical devices; however, IUC 940.000 will not mandate that they have to be submitted at entry declaration.. However, registration and listing can still be provided (and should be):
1. Device Manufacturer’s Registration Number (DEV)
2. Device Manufacturer’s Listing Number (LST)
3. Device Foreign Exporter’s Registration Number (DFE)
4. 510(k) or PMA number (PM #) - most (if not all) face masks require a 510(k)
Please also see: FDA ACE External Outreach Presentation- Medical Devices
For EUA masks (see instructions below if you need to apply for EUA):
ACE Transmission Requirements
The data elements required to transmit a medical device in ACE can be found starting on page 217 of the FDA Supplemental Guide.
Program Code: DEV
Processing Code: NED
Intended Use Code: 940.000 Compassionate use/emergency use FDA Supplemental Guide
Product Code: face mask dependent, but required
Registration and listing are required for all medical devices; however, IUC 940.000 will not mandate that they have to be submitted at entry declaration.. However, registration and listing can still be provided (and should be):
5. Device Manufacturer’s Registration Number (DEV)
6. Device Manufacturer’s Listing Number (LST)
7. Device Foreign Exporter’s Registration Number (DFE)
8. 510(k) or PMA number (PM #) - not applicable to EUA devices
Please also see: FDA ACE External Outreach Presentation- Medical Devices
Further information on importing face masks:
All medical devices regulated by FDA are subject to registration and listing requirements, please refer to How to Register and List and Who Must Register, List and Pay the Fee.
Please refer to CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 on filing PPE.
Please see the following information on N95 and Surgical Masks: https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf
Hand Sanitizers:
The document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-191) Guidance for Industry, is specific to the domestic manufacture of hand sanitizer. At this time, the import process and admissibility requirements for OTC drug products, such as hand sanitizer, have not changed due to the COVID-19 pandemic.
Additional information on importing drug products is included below:
Thank you for your inquiry regarding Importing Human Drugs. Please also see this Overview for Importing Human Drugs.
Summary
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 covered by the appropriate approved and/or active application (NDA/ANDA/BLA/IND, if required).
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.
7. Hold the goods in the shipment intact until you are notified that it is okay to distribute.
8. If the FDA or another agency requests to examine the goods, please make them available for exam.
9. Once the entry has been transmitted to the FDA, you can monitor the real-time status of your shipment with your Customs entry number via ITACS at https://itacs.fda.gov/itacs/app/welcomeToITACS.jsf.
a. You can also submit documents, submit locations for exam, and obtain Notices of FDA Action via ITACS.
GENERAL DRUG IMPORT INFORMATION
You will first need to determine if your product is an Over The Counter (OTC) or Prescription (Rx) drug, as well as, its intended use. These elements will assist in determining the regulatory requirements for your product.
For products intended to be sold in the U.S. market:
· Over the counter drugs that conform to a final monograph may be marketed without a new drug application. Products that do not conform to an applicable OTC monograph must be reviewed by the New Drug Application (NDA) process. The OTC monographs may be found on FDA's website at the following link: https://www.fda.gov/drugs/over-counter-otc-drugs/status-otc-rulemakings
Please note, all over the counter drug products are subject to drug establishment registration, drug listing, and good manufacturing practice (GMP) regulations as well as all existing drug labeling requirements described in section 502 of the Act (21 U.S.C. § 352) and in 21 CFR 201, including the "Drug Facts" labeling requirements under 21 CFR 201.66. Registration and listing requirements are found in 21 CFR 207 and drug GMPs in 21 CFR 211.
· Prescription drugs must be subject to an approved marketing application in the U.S. unless otherwise exempt.
Please note, all prescription drug products are subject to drug establishment registration, drug listing, and good manufacturing practice (GMP) regulations as well as all existing drug labeling requirements described in section 502 of the Act (21 U.S.C. § 352) and in 21 CFR 201, including the "Drug Facts" labeling requirements under 21 CFR 201.66. Registration and listing requirements are found in 21 CFR 207 and drug GMPs in 21 CFR 211.
Registration and Listing: 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. per by Section 510(i) and (j) of the Act [21 U.S.C. § 360] 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. Foreign drug manufacturers must register with the FDA, and the drug products must be listed with FDA before they may be imported into the U.S. The necessary registration and listing forms can be found on FDA’s web site at: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-registration-and-listing-system-drls-and-edrls.
Labeling: Please ensure the product(s) are labeled in accordance with all FDA laws and regulations. Please see the FD&C Act Section 502, 21 CFR 207, and this list of Labeling Guidance, as well as, OTC Drug Facts Label, OTC Guidance Documents, and Small Entity Compliance Guidance.
Good Manufacturing Practices: Please ensure the product(s) were manufactured in accordance with the applicable Pharmaceutical Quality/Manufacturing Standards (CGMP), including those regulations in 21 CFR 211.
For product-specific information, please contact Center for Drug Evaluation and Research (CDER) 301-796-3400 or by email at [email protected].
ACE TRANSMISSION REQUIREMENTS:
ACE requirements for electronic transmission to FDA can be found in the FDA Supplemental Guide starting on page 79.
Program Code: DRU
Product Code: Use Product Code Builder. Only certain industry codes can be used with this program/processing combination. See FDA Supplemental Guide for specifics.
For all other required data elements, please refer to the FDA Supplemental Guide
For a standard entry of a drug intended for the U.S. market, you will need, at minimum, the REG (Drug Manufacturer’s DUNS Number), the DLS (Drug Manufacturer’s Drug Listing Number) and may also require DA (NDA/ANDA/BLA number). Please review the FDA Supplemental Guide for specific requirements based on intended use and product.
Please also see: FDA ACE External Outreach Presentation-Drugs
Customs Guidance
CBP Importing Info: https://help.cbp.gov/app/answers/detail/a_id/197/noIntercept/1
· HTS/PGA Cross Reference Guide: https://www.cbp.gov/document/guidance/agency-tariff-code-agency-program-cross-reference
· Locate a Port: http://www.cbp.gov/contact/ports
For import questions not related to prior notice, contact the Division of Import Operations at [email protected]
For ACE related questions, contact [email protected]
