How to Import Pharmaceuticals to the US

If you are a US resident, you are well aware by now that prescription drugs can sometimes cost a fortune. This situation, coupled with the troubled state of health insurance, has many Americans seeking less expensive prescription drugs from China, Mexico, and Canada. Prices are cheaper north of the border because Canada limits how much drugmakers can charge for medicines, as opposed to the United States, where the free market determines drug prices.According to a recent University of Florida study, two million Americans buy prescription drugs outside the country. Sadly, statistics show that over 45 million Americans do not fill their prescriptions because of the cost. The pharmaceutical industry and its allies continue to perpetuate the myth that drug importation is unsafe. However, their stance is pretty hypocritical when you consider that FDA Commissioner Margaret Hamburg said on The Diane Rehm Show that already back in 2014, 40 percent of all finished prescription drug products sold in the US were manufactured outside the US, and 80 percent of key pharmaceutical ingredients used in US manufacturing were imported, notably from China. The fact is, if you use a verified pharmacy, you can safely import low-cost drugs from abroad. Kelly Ann Barnes, JD, RPh, Vice President of PharmacyChecker.com, “pharmacies in other countries are regulated by pharmaceutical laws with oversight and enforcement from regulators. These pharmacies must follow safety requirements for the handling and dispensing of medications, including the requirement to only dispense lawfully manufactured medications produced under Good Manufacturing Practices or GMP.”According to the World Health Organization, “A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.” PharmacyChecker is a great resource that allows you to look up a drug alphabetically and source different pharmacies to supply you with the prescription you need. They also do a price comparison, so you can see how much you will pay. And you can rest assured that these distributors have been vetted because online pharmacies listed on PharmacyChecker.com and authorized to publish the PharmacyChecker.com Seal have demonstrated they meet high standards of pharmacy practice.Currently, several US states are proceeding with plans to begin importing prescription drugs from Canada as the Biden administration lays out its position. Of course, with politics and the pharmaceutical industry involved, things are complicated! With any luck, Americans will get a break soon from dealing with all the red tape around importing drugs into the US. Until then, if you plan to import drugs, be sure you follow the protocol to ensure that you have the proper paperwork and you are in compliance with the law. So, what are the steps involved in importing pharmaceuticals to the US? As mentioned above, vet the supplier to make sure they are legitimate.

Compliance with the FDA

According to the nonprofit information organization KFF, for a drug to be marketed in the United States, it must first receive FDA approval and meet standards outlined in the Food and Drug Cosmetic (FD&C) Act of 1938. Any drug that is “unapproved,” meaning it does not meet these standards, is not eligible for importation. Currently, the only type of legally imported drugs are those that are: 1) manufactured in foreign FDA-inspected facilities, the subject of an FDA-approved drug application, intended for use by U.S. consumers, and imported into the U.S. by the drug manufacturer, and 2) those that are U.S.-approved and manufactured in the U.S., sent abroad, then imported back into the U.S. under rare circumstances such as for emergency medical purposes or in the case of product recalls. These importation regulations pertain only to the drug product itself and are not related to the cost of imported products.If you have a business that is planning on importing pharmaceuticals into the US, the first step for you is registering with the FDA by filing online. You must fill out an Establishment Registration SPL document and you must be sure that any drug you will be importing has been cleared by the FDA.

Clearing Your Pharmaceuticals Through Customs

Clearing customs is a crucial step and this requires (as you may have guessed) a lot of paperwork. You want to make sure all the i’s are dotted and t’s crossed to avoid your shipment being delayed or rejected. This is a comprehensive list of the documents you will be required to include:

• Packing List
• Bill of Lading
• Importer Security Filing (ISF)
• Commercial Invoice
• CBP Form 3461
• CBP Form 7501
• Arrival Notice
• Customs Bond
• Commodity Specific Documentation

Filing an ISF To Clear Customs

If your pharmaceuticals are coming from overseas, it stands to reason they will be arriving at U.S. ports via ocean vessel. If that is the case, an ISF (also known as a “10+2”) must be filed with the CBP a minimum of 24 hours prior to your cargo leaving its country of origin.The reason the form is known as a 10+2 is for the 10 ISF requirements coupled with the 2 carrier requirements.These are:

1. Buyer
2. Seller
3. Consignee Number
4. Importer of Record Number
5. Ship to Party
6. Manufacturer or Supplier
7. HTSUS Number
8. Country of Origin
9. Consolidator
10. Container Stuffing Location

The carrier requirements are:

1. Container Status Messages
2. Vessel Stow Plan

After compiling this information, you have two choices on how to file it. You can file yourself, which means you’ll have to go to the CBP website and apply for an Automated Commercial Environment (ACE) account. Once you possess an account, you then register your Importer ID number by filling out CP Form 5106 and submitting it to the CBP. You can also visit an American port of entry and register your ID number.Once your eligibility for the ISF portal is confirmed, you will be able to enter your information into the ACE portal.

Do I Need A Customs Bond To Import Pharmaceuticals?

Yes. A customs bond, also known as a surety bond or import bond, is purchased by the importer to ensure that the duties and taxes owed to the U.S. government are covered if the importer is unable to pay them. A customs bond works much as an insurance policy would. Holding a customs bond protects you as an importer from any unexpected costs that might arise from customs-related issues, as it will cover your customs-related costs up to the value of the bond. The bond also paves the way for getting your shipments through US Customs & Border Protection (CBP) or through the requirements set up by the Canadian Border Services Agency. It provides guarantees to these government agencies that you can fulfill any financial responsibilities related to paying duties, penalties, or any other financial obligation.KFF, a nonprofit information organization, is a great resource to learn more about all things related to importing pharmaceuticals. See their 10 FAQs on Prescription Drug Importation for more detailed specifics. At BorderBuddy, we understand the complexities of border controls and customs regulations involved in importing pharmaceuticals into the US. So if you’re feeling a little overwhelmed by the bureaucracy, be sure to give us a call today. No matter how big or small your business is, Border Buddy can help you with the import process.