How To Export Medicine From The USA? A 2025 Guide

Understanding how to export medicine from the USA is a complex and highly regulated process, involving adherence to stringent federal laws, documentation, and compliance with international trade requirements. 

From ensuring FDA approval and acquiring the necessary certifications to navigating customs procedures and adhering to import regulations of the destination country, the process can be overwhelming for businesses. 

However, with the right knowledge and tools, it can be efficiently managed. One such tool is Artemus’ Automated Export Filing (AES) Solution, which simplifies the export declaration process.

Trade Figures For USA Medicine Exports To Other Countries

The United States is a leading global exporter of medicinal and pharmaceutical products, with significant trade figures indicating the scope of its industry. In recent years, U.S. medicine exports have consistently grown, driven by innovation, high-quality standards, and global demand.

In 2023, U.S. pharmaceutical exports reached approximately $77 billion, showing robust growth. Key markets include developed economies like Germany, which imported over $50 billion worth of pharmaceuticals, and France, importing over $11 billion. 

Other prominent export destinations are Japan, the United Kingdom, and Canada, emphasizing the strong trade relationships in regions such as Europe and North America.

The United States also caters to emerging markets, reflecting a diverse export portfolio. For example, countries in Asia and Latin America have shown increasing demand for U.S. medical products. India, a significant player in the global pharmaceutical industry, imported about $3.4 billion worth of U.S. medicines in 2022​.

This upward trajectory in U.S. pharmaceutical exports highlights its competitive edge in drug development, regulatory compliance, and manufacturing excellence, positioning it as a key player in the global healthcare landscape​.

Related: Exporting Mangoes From India To The USA: How To Ship?

How To Export Medicine From The USA? A Step-By-Step Guide

Exporting medicine from the USA is a complex process that requires compliance with U.S. regulations and the requirements of the destination country. Here is a comprehensive, step-by-step guide to assist you in navigating this process:

1. Understand U.S. Regulations

The U.S. Food and Drug Administration (FDA) oversees the export of pharmaceutical products. Medicines must meet specific standards outlined in the Federal Food, Drug, and Cosmetic Act and comply with FDA regulations:

• Approved medicines must meet FDA standards for safety and labeling.
• Unapproved medicines can be exported under Section 801(e) if they meet the importing country’s regulations and are properly labeled for export use.

Exporters may also need an FDA Export Certificate, such as:

• Certificate Of Exportability: For medicines not approved in the U.S. but allowed for export.
• Certificate To Foreign Government: For FDA-approved medicines​
  FDA, Cargo Export USA.

2. Verify Importing Country’s Requirements

Each country has its own pharmaceutical import regulations. Confirm:

• The medicine is permitted for import.
• Required certifications, including Certificates of Pharmaceutical Products (CPPs), which validate compliance with good manufacturing practices​ Cargo Export USA.

3. Register With Relevant Authorities

Before exporting, ensure compliance with the following:

• Register the manufacturing facility and product with the FDA.
• Obtain permits and licenses from U.S. and international trade authorities such as the U.S. Department of Commerce and the Bureau of Industry and Security, if required.

4. Package & Label Correctly

Proper labeling is critical:

• Clearly state that the product is intended for export.
• Follow both FDA and importing country labeling guidelines. Packaging must be secure and compliant with international shipping standards​ FDA, Cargo Export USA.

5. Secure Documentation

Prepare the necessary paperwork:

• Commercial invoice and packing list.
• Bill of lading or airway bill.
• Certificates of origin, export, and analysis.
• Export licenses and the FDA’s Certificates (if applicable).

6. Choose A Reliable Shipping Partner

Select a logistics company experienced in handling pharmaceutical products. They must adhere to cold-chain requirements (if applicable) and ensure secure transport to prevent tampering.

7. Adhere To Customs Requirements

Work with customs brokers to:

• Classify the product correctly under the Harmonized Tariff Schedule (HTS).
• Pay applicable duties and taxes.

8. Monitor Compliance Post-Export

Maintain records for each shipment for at least five years. Be prepared for audits from the FDA or importing country authorities

What Federal Agency In The USA Regulates Medicine Exports?

The primary federal agency responsible for regulating medicine exports in the United States is the Food and Drug Administration (FDA). The FDA ensures that medicines exported from the U.S. comply with federal laws and international standards. 

Here are key points about the FDA’s role in regulating medicine exports:

1. Overview Of The FDA’s Role

The FDA oversees the safety, efficacy, and labeling of pharmaceutical products, both for domestic use and export. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA regulates the export of:

• FDA-approved drugs.
• Unapproved drugs, provided they meet the requirements outlined in Section 801(e) of the FDCA.

2. Export Certificates

The FDA issues various certificates to facilitate pharmaceutical exports:

• Certificate of Exportability: For unapproved drugs permitted for export.
• Certificate to Foreign Government: For approved drugs that meet U.S. manufacturing and marketing standards.
• Certificate of Pharmaceutical Product (CPP): Required by some countries to verify compliance with good manufacturing practices and regulatory standards​ FDA, Cargo Export USA.

3. Labeling & Documentation

Medicines must be properly labeled as export-only and meet the packaging and documentation requirements of both U.S. and importing country regulations. The FDA ensures that exported drugs are not adulterated or misbranded according to U.S. law.

4. Collaboration With Other Agencies

The FDA works alongside other federal agencies, such as:

• The U.S. Customs and Border Protection (CBP) for customs clearance.
• The U.S. Department of Commerce for trade facilitation.
• The Bureau of Industry and Security (BIS) for compliance with export controls on certain products.

Do You Need Any License To Export Medicine From The USA?

Yes, you need specific licenses and certifications to export medicine from the USA. The process involves compliance with various federal and international regulations. Below are the primary requirements for obtaining the necessary licenses:

1. FDA Export Certificate

The Food and Drug Administration (FDA) mandates that pharmaceutical exporters secure appropriate export certificates, depending on the nature of the medicine:

• Certificate Of Exportability: For medicines not approved for sale in the U.S. but permissible for export.
• Certificate To Foreign Government: For FDA-approved medicines meeting U.S. manufacturing and marketing standards.
• Certificate Of Pharmaceutical Product (CPP): Often required by importing countries to confirm compliance with international manufacturing standards​.

2. Federal Export Licenses

In addition to FDA requirements, you may need:

• Export Permits: Issued by agencies such as the Bureau of Industry and Security (BIS) if the medicine falls under controlled substances or dual-use goods.
• Customs Clearance: Through U.S. Customs and Border Protection (CBP), ensuring compliance with the Harmonized Tariff Schedule (HTS) for pharmaceuticals.

3. Register As An Exporter

Exporters must:

• Register the manufacturing facility with the FDA.
• Ensure adherence to the FDA’s Current Good Manufacturing Practices (CGMP).
• Ensure that the medicines meet both U.S. and importing country regulatory standards​.

4. Additional Importing Country Requirements

The destination country may have its own licensing requirements for pharmaceuticals, including:

• Import permits.
• Proof of compliance with their health authority regulations (e.g., the European Medicines Agency or WHO standards).

Related: How To Export From India To USA? A 2024 Updated Guide

Documents Required To Export Medicine From The USA

To export medicines from the USA, several critical documents are required to ensure compliance with U.S. federal regulations and the importing country’s requirements. Here’s a detailed list of the essential documents:

1. Certificate Of Pharmaceutical Product (CPP): Issued by the FDA, this certificate confirms that the exported medicine meets U.S. standards for quality, safety, and efficacy. It is often required by the importing country’s regulatory body.
2. Commercial Invoice: This document includes detailed information about the shipment, including the description of the medicines, their value, and terms of sale.
3. Packing List: It provides an itemized list of the shipment contents, including dimensions, weights, and packaging details.
4. Bill Of Lading Or Airway Bill: Issued by the shipping or air freight company, it serves as a receipt for the goods and outlines the terms of transport.
5. Export Declaration: Filed electronically through the Automated Export System (AES) by the U.S. Census Bureau, this document captures the details of the export transaction.
6. FDA Registration & Listing: All drugs manufactured for export must be registered with the FDA, and a listing of the drug product must be submitted.
7. Import Permit (if required): Some importing countries may require an import permit issued by their national drug regulatory authority.
8. Labeling Compliance Documents: These confirm that the labeling of the medicines adheres to the FDA’s requirements and may also include translations for the destination market.
9. Current Good Manufacturing Practices (CGMP) Compliance: Documentation demonstrating that the manufacturing facilities comply with CGMP standards as assessed by the FDA.
10. Additional Certifications: Some countries may request specific certifications such as Free Sale Certificates, which confirm that the drug is marketed in the U.S., or other quality-related certificates.

The required documents may vary depending on the destination country and the type of drug being exported. It’s essential to consult with the FDA and local authorities in the importing country for precise requirements​.

Related: 10 International Shipping Documents To Must Have In 2024 

Governing Laws To Know To Export Medicine From The USA

When exporting medicine from the USA, various governing laws and regulations must be followed to ensure compliance with both domestic and international requirements. Here are the key legal frameworks to be aware of:

1. Food, Drug, & Cosmetic Act (FDCA)

The FDCA, overseen by the Food and Drug Administration (FDA), is a critical law governing the safety, efficacy, and marketing of pharmaceutical products in the U.S. This act mandates that all drugs manufactured or marketed for export must comply with FDA standards, including ensuring that they meet Current Good Manufacturing Practices (CGMP)​. 

It also stipulates that the FDA issue export certificates to confirm the quality and compliance of the drugs for international trade.

2. FDA Export Requirements

The FDA regulates the export of drugs through specific rules under the FDCA. Exporters must obtain necessary certificates, such as the Certificate of Pharmaceutical Product (CPP), to confirm that drugs meet FDA standards. 

In addition, the FDA’s Center for Drug Evaluation and Research (CDER) ensures that drug exports comply with international safety regulations​.

3. The Export Administration Regulations (EAR)

Administered by the Bureau of Industry and Security (BIS) within the U.S. Department of Commerce, the EAR governs the export of dual-use items, which include goods and technologies that have both civilian and military applications. 

Some pharmaceutical products, especially those classified as controlled substances or having sensitive technologies, may require a license for export​.

4. International Traffic in Arms Regulations (ITAR)

Though primarily concerned with defense-related items, ITAR can impact pharmaceutical exports if the products are considered to have military applications. Medicines containing controlled substances or that fall under certain categories of biological agents may be subject to these regulations​.

5. Drug Enforcement Administration (DEA) Regulations

For narcotic and controlled substances, the DEA plays a key role in regulating their export. Exporters must comply with DEA’s controlled substance export regulations, including obtaining necessary permits when shipping drugs classified as narcotics or other controlled substances. This ensures that these drugs are not diverted to illegal markets​.

6. World Trade Organization (WTO) Agreements

For international trade, the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement may influence the export of medicines. TRIPS sets out the international standards for intellectual property (IP) rights, which can affect the export of patented pharmaceuticals.

7. Import Regulations Of The Destination Country

In addition to U.S. laws, exporters must also adhere to the import regulations of the country to which the medicine is being shipped. This may include providing certificates of compliance, registration with the destination country’s health authority, and meeting their specific import standards. 

Many countries require import permits or health clearance certificates before allowing pharmaceutical products into their borders.

Related: What Is Global Trade Compliance & Its Key Components

Compliance Requirements For Exporting Medicine From The USA

When exporting medicine from the USA, it’s essential to comply with a range of regulatory and documentation requirements to ensure that the pharmaceutical products meet safety and quality standards for both the U.S. and international markets. Here are the key compliance requirements:

1. FDA Compliance

The Food and Drug Administration (FDA) is the primary regulatory body overseeing the export of pharmaceutical products from the U.S. Exporters must comply with the Food, Drug, and Cosmetic Act (FDCA), which mandates that all drugs meet FDA’s stringent safety and efficacy standards. 

This includes compliance with Current Good Manufacturing Practices (CGMP) for manufacturing drugs, ensuring they are produced under conditions that guarantee their quality​. 

Exporters must also obtain a Certificate of Pharmaceutical Product (CPP), issued by the FDA, to confirm the drug’s compliance with these standards for the destination country​.

2. Export Documentation

To comply with U.S. export regulations, several documents are required, such as:

• Export Declaration: This must be filed electronically with the Automated Export System (AES) through the U.S. Census Bureau.
• Certificate Of Pharmaceutical Product (CPP): Essential for verifying that the medicine meets international quality and safety standards​.
• Commercial Invoice & Packing List: These provide detailed information about the product, packaging, and shipment.
• Bill Of Lading Or Airway Bill: This transport document is necessary for proving that the goods were shipped.

These documents ensure that the export is legal, safe, and in compliance with international trade laws​.

3. DEA Compliance for Controlled Substances

If exporting controlled substances or narcotics, the Drug Enforcement Administration (DEA) enforces additional compliance rules. Exporters must obtain specific permits for such shipments, ensuring that the products do not enter illicit markets. This process includes filing an export permit application with the DEA​.

4. Compliance with Import Regulations of the Destination Country

Different countries have their own regulatory frameworks for importing medicines. Most nations require pharmaceutical products to be registered and comply with their local health authorities’ regulations. 

These might include import permits, drug testing, and clearance by the country’s equivalent of the FDA or health ministry. It’s essential to ensure that all required certifications are in place before shipment​.

5. Harmonization & Certification Schemes

Many countries follow international certification schemes, like the World Health Organization (WHO) certification, to ensure the quality of drugs being imported. Some nations also rely on Free Sale Certificates, which verify that the drugs are legally available in the U.S. market and meet quality standards​

6. Compliance With The Export Administration Regulations (EAR)

Certain medicines, particularly those containing sensitive technologies, may fall under the Export Administration Regulations (EAR), enforced by the Bureau of Industry and Security (BIS). These regulations control the export of dual-use goods, which have both civilian and military applications, and certain drugs may require additional licensing​.

7. World Trade Organization (WTO) Agreements

The TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement under the World Trade Organization (WTO) also impacts pharmaceutical exports. It requires compliance with international intellectual property rights and patents, ensuring that pharmaceutical exporters respect the patents of drugs produced by other manufacturers​ FDA.

8. Compliance With Local Customs & Tariffs

Customs laws in the destination country must also be followed. This includes ensuring that proper tariff codes are applied to the medicines being exported and that the correct customs duties are paid. Inaccuracies in this area can delay shipments or result in fines

Related: What Is Import Compliance & Why It Matters?

Artemus: Automated Export Filing (AES) Solution For Your USA Exports

Artemus provides an efficient Automated Export Filing (AES) solution tailored for businesses & individuals exporting goods from the USA. With compliance at its core, the Artemus AES software simplifies the process of filing export declarations to the U.S. Census Bureau via the Automated Export System (AES). 

This solution automates the documentation process, ensuring that exporters meet all regulatory requirements, including reporting export data, tracking shipments, and maintaining necessary records. 

By streamlining AES filings, Artemus helps businesses reduce errors, avoid penalties, and expedite export operations, making it an indispensable tool for exporters looking to navigate complex U.S. export regulations seamlessly.

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FAQs

1. How Can I Import Medicine From The USA To India?

To import medicine from the USA to India, you need to follow the guidelines set by the Central Drugs Standard Control Organization (CDSCO). Importers must register the products with the CDSCO, ensure they comply with Indian regulations, and acquire an Import License. Additionally, medicines must pass quality control checks by the Drug Controller General of India (DCGI).

2. How Do I Become A Medicine Exporter?

To become a medicine exporter, you need to ensure compliance with regulations like FDA approval for the products, obtain an export license, and adhere to documentation and customs requirements. Additionally, you must register with the U.S. Census Bureau for export filings and possibly obtain certifications like the Certificate of Pharmaceutical Product (CPP) from the FDA.

3. Who Is The Biggest Medicine Exporter?

India is one of the largest medicine exporters globally, with India accounting for approximately 20% of the world’s generic medicine supply. In terms of country exports, Germany and the United States are also major players in the pharmaceutical export industry.

4. Can I Ship Medicine To India From The USA?

Yes, you can ship medicine to India from the USA, but the shipment must comply with Indian regulations, including obtaining an Import License and ensuring the medicines are registered with the CDSCO. It’s essential to provide documentation such as FDA certificates to ensure smooth customs clearance.

5. What Is The Cost Of A Drug Import License In India?

The cost of obtaining a drug import license in India varies depending on the type of drug being imported and the processing fees set by the CDSCO. For example, the license application fee can range from ₹1000 to ₹5000 for different drug categories, though additional costs may apply for inspections and documentation.

6. Can Medication Be Shipped To The USA?

Yes, medications can be shipped to the USA, but they must comply with FDA regulations and be authorized for importation. Certain controlled substances may require special permits from the Drug Enforcement Administration (DEA).

7. Can I Ship Medicines From India To The USA?

Shipping medicines from India to the USA is possible, but the drugs must meet FDA standards and be registered with the FDA for importation. Specific documentation, such as importer declarations and FDA certification, is required to ensure compliance with U.S. laws.

8. How Can I Import Medicine Into The USA?

To import medicine into the USA, you must comply with FDA regulations, ensure the product is FDA-approved, and submit necessary documentation such as Import Drug License and FDA certificates. Controlled substances require additional compliance with DEA regulations.

Related: Understanding Roll-On/Roll-Off Ships: A Complete Guide

Conclusion

Exporting medicine from the USA is a complex and highly regulated process, involving adherence to stringent federal laws, documentation, and compliance with international trade requirements. 

From ensuring FDA approval and acquiring the necessary certifications to navigating customs procedures and adhering to import regulations of the destination country, the process can be overwhelming for businesses.

Related: Customs Clearance Delays In 2024: Top 10 Reasons & Solutions