The Food and Drug Administration (FDA)
Note: for further information on FDA issues or Product Building please contact PBB's Trade & Regulatory Services experts. In Canada: (905) 871-6500 or trsca@pbb.com. In the U.S.: (716) 692-3100 or trs@pbb.com .

The Food and Drug Administration (FDA) regulates the importation of:

• Human food and food ingredients (including wild game used for food)
• Seafood
• Animal feed and animal feed ingredients
• Human and animal drugs (anything, components of anything used for or intended for diagnosis, prevention, treatment or cure of disease)
• Medical devices
• Human biological products (blood, blood by products, antitoxins, vaccines, therapeutic serum)
• Human cosmetics and components
• Food service containers
• Radiation emitting products

Examples of products:

Drugs
Antibiotics Bulk & finished dosage forms of drugs Antitoxins, Enzymes, VenomsIn-Vitro Diagnostic Products Blood/Blood DerivativesIn-Vivo Diagnostic Products Prescription DrugsVaccines Non-prescription

Animal Products
By-products for feed (meal, corn cobs, etc.)Pet Foods (cat, bird, dog, horse, fish, etc.) DrugsSilage for feed Feeds (medicated & non-medicated)

Devices
Diagnostic Devices, Medical Devices

Radiological Health
Cathode Tubes, Therapeutic Ultra-sound Equipment, Infra-red lights(infrasonic, sonic), Lasers, Ultra-violet lamps (sun lamps), Microwave Ovens, Video (TV’s, monitors, cathode ray tubes, X-ray units & Components, oscilloscopes, TV projection systems)(film, testing systems)

General Importing Information

The U.S Food & Drug Administration regulates the entry of all products that pose a potential health risk to U.S Consumers. These products include food, medications, medical devices, animal feeds and drugs, cosmetics and radiation emitting devices. For specific information on product requirements and regulations please visit www.fda.gov

The following information is provided as a service to our clients and is subject to change as FDA regulations are amended. PBB's site will be updated to reflect changes as quickly as possible and to provide importers with the most current information available. Please visit www.pbb.com frequently for updates.

In order for PBB to process your shipments in a timely manner the following information MUST be clearly indicated on your Customs Invoice:

1. a complete accurate description of the commodity that is being shipped ( Example: "surgical hand instrument" is not an accurate description, "scalpel" is).
2. the quantity of the product being shipped (4 pallets of canned peaches is not acceptable, 4 pallets each containing 22 boxes each box containing 12 - 10 oz glass jars is)
3. information on the packaging and shipping method ("coffee" does not indicate to us if the coffee is in burlap bags, metal tins or plastic pouches; is the commodity being shipped frozen, refrigerated or at room temperature)
4. the manufacturer of the product - in order for FDA to verify that the product is listed with FDA we must report the complete name and address of the manufacturer of the commodity

Providing any known FDA registration numbers may aid the FDA in verifying the admissibility of the product. Examples of FDA registration numbers include:

1. National Drug Code #'s (NDC) for medications
2. Investigational New Drug #'s (IND) for medications under development
3. Establishment Registration Number (for manufacturer or distributor of FDA regulated goods)
4. Medical Device Listing #
5. Premarket Approval Number (510K#)
6. Accession # for radiological devices
7. New Animal Drug Application # (NADA)
8. Food Canning Establishment # (FCE) for low acid canned foods Providing as much information as possible is necessary for PBB to properly classify FDA regulated goods. Detailed descriptions also make it easier for the FDA to determine the admissibility of your goods. All of this will lead to quicker processing times at the Port of Entry and help to avoid costly delays.

Links

The FDA home page:
http://www.fda.gov

Downloadable FDA Forms:
http://www.fda.gov/opacom/morechoices/fdaforms/cdrh.html

FDA Product Code Builder
(allows you to proper classify your goods for FDA to avoid any confusion at time of entry, it is strongly recommended that you go through the tutorial before classifying your goods):
http://www.accessdata.fda.gov/scripts/ora/pcb/pcb.cfm

FDA Device Advice web page (help determine if your device is a "medical device" and FDA regulated) http://www.fda.gov/cdrh/devadvice/

The Code of Federal Regulations - the Laws & Policies of FDA
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121

The Office of Consumer Affairs, US FDA
http://www.health.gov/nhic/NHICScripts/Entry.cfm?HRCode=HR0030

Importing By The Numbers_{(an excerpt from the PBB Commitment to Service, 10/95 Newsletter)}

Many electronic products manufactured in or imported into the United States are subject to U.S. Food & Drug Administration (FDA) regulations requiring compliance with certain performance standard tests. Every manufacturer or initial distributor (with manufacturer’s approval), must either submit reports to the FDA, documenting product compliance with these standards, or file special exemption requests. The FDA assigns an identification number known as the "accession number" to each of these reports or exemptions.

In addition to the normal FD 701 and where required, the FCC 740 forms, the importation of these products requires the submission of an FD 2877 form: "Declaration for Products Subject to Radiation Control Standards." When completing the FD 2877, the "manufacturer" block should indicate the site-specific address of the actual manufacturer (not the corporate headquarters). If the filer is other than the site-specific manufacturer, the FD 2877 should also indicate the name of the firm who filed the report with FDA.

To expedite FDA’s review of your FD 2877, be sure to include the model and "accession" number(s) for your product(s).

The shipper of covered products must provide the required information (including the accession numbers) for the product being shipped. Failure to provide this information on your shipping documents will delay the release of your goods and could result in FDA refusing entry of your shipment into the United States.

Products subject to these requirements include, but are not limited to, color televisions receivers, color monitors for computers, microwave ovens, sun lamps, computer laser printers and most other laser, ultrasonic and x-ray products. Call BEFORE you ship if you are not sure whether your product is regulated.

PBB is capable of reporting the information to the FDA electronically through the Operational and Administrative System for Import Support (OASIS) program, thereby decreasing the waiting time at the point of importation and increasing the number of "May Proceed" notices.

OASIS has significantly speeded up the time within which FDA makes its admissibility determinations for imported products. Under the legacy manual system, FDA's review processes took days; OASIS routes electronic admissibility decisions to 2200 importers agents' PCs within minutes after their shipment data is transmitted electronically to FDA. With OASIS, 85% of the shipments are cleared without any submission of paper by the importers, versus the previous requirement for submission of paper documentation for all shipments

With the exception of a few permit ports that do not have Customs or Brokers offices, all PBB offices are utilizing OASIS whenever possible.

In order for entries to be processed through the OASIS program at the time of entry (release) PBB release staff must have the following information for each shipped product subject to FDA regulation.

• Actual FDA Manufacturer
• FDA Shipper
• FDA Country of Origin
• FDA Product Code (we can determine this for a one time set up fee per commodity)
• FDA Description
• FDA Value
• FDA Consignee Name/Address and IRS number
• FD 2877 for Radiation Emitting Devices
• Accession Number (for radiation emitting devices)
• FCC 740 if it is an electronic device (required for radiation emitting devices)

Radiological Health - FD2877 Completion
_{(an excerpt from the FDA Newsletter 6/3/95)}

The following are a few examples of Radiological Health Products which MUST also have a SIGNED FD 2877 : television receivers, CRT Monitors, cathode gas discharge tubes, laser & laser products, microwave ovens, ultrasonic therapy products, diagnostic X-ray systems & high intensity mercury vapor discharge lamps, cellular phones and any components of these products. These same regulations also apply to U.S. manufactured products.

We have recently encountered some problems with paperwork submitted in support of entries of radiation-emitting devices.

Federal regulations require that all imported electronic products for which applicable FDA radiation performance standards exist shall comply with these standards and shall bear certification of such compliance. Before these products can be permitted to enter the U.S., manufacturers and importers are required to submit with each shipment certain required import entry papers through the District Director, U.S. Customs Service, to the appropriate FDA district office. Included is the form FD 2877 entitled "Declaration for Products Subject to Radiation Control Standard."

When filling out the FD 2877 form, the "manufacturer" block must indicate the actual site-specific manufacturer (not a corporate headquarters’ address). In addition, the FD 2877 should indicate the firm which filed the report with CDRH¹, if not the actual, site-specific manufacturer. In order to speed up review of your FD 2877, also obtain the Accession #s and Model #s for the product.

¹CDRH - Center for Devices and Radiological Health

Imported Drugs
_{(an excerpt from "Requirements of Laws and Regulations Enforced by the U. S. Food and Drug Administration)}

Persons wishing to ship a drug to the United States, and persons in the United States wishing to import the same must bear in mind that the article may be detained and refused admission if it does not comply with the applicable drug provisions of the Federal Food, Drug and Cosmetic Act. In order to arrange for entry of drug preparations and drug components, the shipper must determine which of the above classifications apply to it, and whether all requirements for each of such classifications have been met.

A drug which has been used outside of the United States, and which may be regarded as safe and effective by experts in other countries, but which has not been marketed in this country, is likely to be regarded as a new drug under U.S. law. A new drug will be admitted only if the Food and Drug Administration has approved a New Drug Application for it.

Section 801 of the Act (21 U. S. CUSTOMS 381), as amended by the Prescription Drug Marketing Act, generally prohibits the reimportation of American-made drugs by anyone other than the original manufacturer.

The FDA does permit the limited importation of prescription medication for visiting Canadian residents and U.S. citizens provided certain criterion is met.

A Canadian resident visiting the U.S. may import prescription medications that contain no more than a 30 day supply. The immediate container must be properly labeled and a copy of the prescription from their physician must accompany the importation.

A U.S. resident wishing to import a medication from Canada must meet the same criterion as stated above with the exception that the prescription must be from their personal physician in the United States and the medication has to be one that has been approved for use in the United States but is not yet available on the market.

Other regulating agencies include the United States Coast Guard for boats; The Drug Enforcement Agency for narcotics, precursor chemicals used to make drugs and other controlled substances; The Immigration and Naturalization Service which deals with persons, rather than things, crossing the border; The Consumes Protection Safety Commission for certain specified products; The Office of Foreign Assets controls sanctions and embargoes against products of specified countries; The Nuclear Regulatory Commission for nuclear reactors and some radioactive materials and by-products; and The Department of State for war materials and shrimp.

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