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Exporting prescription drugs from the U.S. can be a pretty challenging task for an inexperienced exporter. Since prescription drugs are meant for human use, ensuring that the drugs you’re sending to another country are safe is important. There will be many regulations that you’ll have to abide by to prove that your shipment of prescription drugs is safe for consumption.
According to the Food and Drug Administration (FDA), to export prescription drugs from the U.S., you’ll have to abide by the guidelines of the Export Reform Enhancement Act Of 1996. In addition to those regulations, your shipment will need to be accompanied by an export certificate, and other related documents needed to export.
Exporting prescription drugs from the U.S. can be challenging, but as long as you follow the correct regulations, the process will be a breeze.
In the U.S., there are 2,015 pharmaceutical manufacturing businesses in operation. All of these businesses not only provide prescription drugs to U.S. citizens, but to foreign buyers in other countries as well. Over the past few years, the U.S. has been exporting an extremely large amount of pharmaceuticals to buyers all over the world.
To show how much growth has occurred, we’ve provided a table of the U.S. biopharmaceutical exports in 2018 and 2019.
| Export Year | Product Value |
| 2018 | 54.7 |
| 2019 | 60.2 |
As this table shows, there’s a growing demand for U.S. pharmaceuticals around the world. That said, there are many regulations you’ll need to follow if you want to be a supplier to buyers in foreign countries.
The U.S. federal government has three agencies that dedicate themselves to the export of pharmaceutical drugs.
These agencies are:
The FDA concerns itself with the safety of all goods that are used by humans and animals. Aside from many regulations concerning the safety of these goods when imported into the U.S., the FDA also has strict regulations for exporting these goods.
The U.S. Census Bureau doesn’t have regulations that apply specifically to prescription drug exports. Rather, it tracks all U.S. exports that leave the country. Therefore, you will need to provide the information required for them to document your prescription drug export when it leaves the country.
DEA regulations apply to pharmacies whose controlled substances are imported by foreign buyers overseas. Their regulations are fairly simple and only require exporters to fill out some simple paperwork.
One document that guides many of the FDA’s export regulations when exporting goods is the FDA Export Reform Enhancement Act of 1996. This act provides a good deal of important guidelines to follow when exporting prescriptions to foreign countries. When exporting prescriptions outside the country, the primary regulations are related to Section 801 of the act.
Section 801 of the Enhancement Act is broken down into 12 different chapters. The first four chapters essentially lay out some basic information and background on Section 801.
The chapters are broken down as follows:
Chapter five of Section 801 is where regulations for exporting pharmaceutical drugs to other countries come into play. This part of the act describes all of the regulations related to exporting controlled substances. The main ones that you should concern yourself with are the ones we’ve listed below.
As the name of this chapter of Section 801 implies, these are the basic and general requirements that you will need to follow to export pharmaceutical products. After going through and completing regulations in the General Requirements chapter, you must complete the sixth chapter Section 801: Labeling Requirements Chapter.
Among other things, this chapter of the act states that labeling can be to the specifications of the importer of drugs. That said, the labeling must be in line with the FDA’s requirements as well. Next, chapters seven through nine describe the requirements for exporting drugs not approved by Section 801.
These chapters are called:
The final three chapters have regulations that apply to different topics. They are:
Of all of these 12 chapters, the issued regulations of chapters five, six and 11 are practically universal. All exported drugs will be subject to the regulations in these chapters. Chapters seven through 10, however, only have to be followed on a case-by-case basis.
Not all exports of prescription drugs fit the regulations of chapters seven through 10. Rather, you must find which of these four best describes your shipment. Working your way through the details of Section 801 can be tiresome. Consider working with a certified export consultant to help you through the process.
Section 801 of the FDA’s Export Reform Enhancement Act does contain many of the regulations that you’ll need to follow to export your pharmaceutical drugs. However, it doesn’t contain all of the guidelines you’ll need to follow.
We’ve laid out some additional FDA pharmaceutical export requirements that may apply to your exports.
After you’ve gone through all of the applicable regulations that apply to your pharmaceutical drug export domestically, it’s time to examine foreign requirements. Just as the U.S. has the FDA to regulate goods meant for human and animal use or consumption, foreign governments around the world have their own agencies responsible for drug enforcement.
Oftentimes, foreign importers will ask you to provide a certificate that shows that the drugs you’re exporting are safe for consumption. A certificate from the FDA can cover most of the information requirement needs.
The FDA provides the following certificates:
To export prescription drugs, you’ll need to either obtain a Certificate Of A Pharmaceutical Product’, Certificate To Foreign Government or a Certificate of Exportability. The Certificate Of A Pharmaceutical Product is applicable for both human and animal drugs.
This certificate is written in a format established by the World Health Organization (WHO). Both the Certificate To Foreign Government and the Certificate Of Exportability can be used for human and animal drugs. The difference between them is that the Certificate To Foreign Government are for pharmaceuticals that meet the requirements for marketing in the United States, while the Certificate Of Exportability is for pharmaceuticals that can’t be marketed.
Based on the pharmaceutical export that you’re shipping out and the information the importer provides, you will need to determine which certificate is necessary.
CPP information or Certificates of the Pharmaceutical Product, are other items that a foreign importer will likely ask you to provide. The CCP gives information about the marketing status of the exported FDA-approved drugs. It also certifies that the manufacturer who made the pharmaceuticals did so in compliance with FDA standards.
The FDA publishes resources for foreign importers that lets them determine if the pharmaceuticals they’re importing from the U.S. are FDA-approved and whether or not the facility that made the prescription drugs passed FDA inspections.
These resources are located at:
Obtaining a CPP is extremely important when you’re an exporter of prescription drugs. You can apply for a CPP online at FDA’s Center for Drug Evaluation and Research Export Certification Application and Tracking System (CDEReCATS). CPPs are good for any amount of pharmaceutical exports for two years. Be sure to obtain a new CPP before the old one expires.
If you’ve been denied a CPP, you can try obtaining a CGMP or Current Good Manufacturing Practice Declaration. According to the FDA, you’re only required to apply for one if the foreign importer or regulator doesn’t accept a valid CPP.
You can obtain a CGMP declaration from the CDEReCATS the same way you can a CPP. That said, the FDA does have a few rules that you must follow when obtaining this declaration.
Applicants should follow these rules:
If the FDA accepts the request and issues the CGMP, they’ll send it via email to the foreign regulator.
Unsurprisingly, the DEA has its requirements that they enforce on exporters of controlled substances. To satisfy their requirements, you’ll need to register as a yearly exporter with them. This can be done by completing what’s called a DEA Form 225.
The DEA Form 225 is intended primarily for pharmacies that export controlled substances to foreign nations. You should submit this form well before you plan to export your controlled substance.
The DEA Form 225 will take anywhere between four to six weeks to fully process. On top of that, you can expect annual renewal fees of $1,500 for this form as well.
As per U.S. Census Bureau regulations, you’ll need to provide a Schedule B Number for your exported shipment of prescription drugs.
That said, the U.S. Census Bureau only requires you to provide a Schedule B Number under two circumstances:
Given the certificate and registration requirements of the DEA and the FDA, and the fact that prescription drugs are expensive, you’re going to need a Schedule B Number for your export. Schedule B Numbers are split up into different chapters. To find the Schedule B Number for your prescription goods, simply go to chapter 30 of Schedule B, 2022 edition.
If you’re exporting prescription drugs to a country the U.S. has a Free Trade Agreement with, a Schedule B Number will be required for your importer to receive preferential tariff treatment on your shipment of goods. Therefore, your buyer might ask you to include one with your shipment.
Following the regulations of each federal agency that regulates prescription drug exports can be a stressful endeavor to undertake. Fortunately, our team at Cargo Exports USA can help you out. We make it our job to keep up with the current federal regulations regarding U.S. exports.
When you choose Cargo Exports USA, you obtain access to the following:
Obtain our services today or get in touch with our team at (866) 301-0635.
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