Public Law 109-73: How to Export Controlled Substances

Public Law 109-57, the Controlled Substances Export Reform Act of 2005, established a regulated framework for exporting certain controlled substances from the United States. The law authorizes the Drug Enforcement Administration (DEA) to permit the export of specific substances for legitimate medical, scientific, or other lawful uses in other countries. Before this act, legal pathways for such exports were highly restricted. This legislation allows U.S. pharmaceutical and research entities to supply necessary substances to international partners under federal oversight, ensuring exports align with domestic law and international drug control treaties.

Scope of Permitted Exports

The Controlled Substances Export Reform Act addresses substances in Schedule I and Schedule II, as well as narcotic drugs in Schedules III and IV. Schedule I substances are those with a high potential for abuse and no currently accepted medical use in the United States, often limiting their export to scientific research purposes. Schedule II substances also have a high potential for abuse but have accepted medical applications, allowing for their export for both clinical and research use.

A requirement of the act is that the importing country must be a party to the Single Convention on Narcotic Drugs of 1961 and the Convention on Psychotropic Substances of 1971. This ensures the destination country has a compatible system for managing controlled substances. The law also mandates that the substances are intended for medical, scientific, or other legitimate purposes within the destination country.

The act includes provisions for reexportation, where a substance is sent to one country for transfer to a second. This is permissible only if both countries are parties to the international conventions and maintain adequate control systems. A condition is that the controlled substance cannot be exported from the second country to a third.

Exporter and Importer Eligibility

For a U.S.-based entity to be eligible, the exporter must be registered with the Drug Enforcement Administration (DEA). This registration must specifically authorize the company to manufacture or distribute the particular controlled substance they plan to export. Registrations for other activities, such as research or dispensing, do not confer the authority to export. The exporter’s legal name and registered address on the application must exactly match their DEA registration certificate.

The foreign importer must hold the necessary permits and licenses as required by the laws of their own country. As part of the U.S. export application, the exporter must provide a copy of the foreign import permit or another official certification from the importing country’s government. This document serves as proof that the national authority of that country has approved the specific transaction.

Information Required for an Export Permit

The application form required depends on the specifics of the export. DEA Form 161 is used for exporting controlled substances in Schedules I and II and narcotic drugs in Schedules III and IV. For non-narcotic substances in Schedules III, IV, and V, applicants use DEA Form 236, while DEA Form 161R is required for reexport.

The application must include the exporter’s full legal name, address, and DEA registration number. It also requires the foreign importer’s complete name and address, which must precisely match what is listed on the foreign import certificate, as any discrepancy can be a cause for rejection. Applicants must also detail the drug’s name, its dosage form, and total quantity; the U.S. port of export and foreign port of entry; and the method of shipment, including the carrier’s name.

The Export Permit Application Process

The complete application package must be submitted to the DEA, which can be done through the DEA Diversion Control Division’s secure online portal. Upon receipt, the DEA reviews the application. A key part of this process is the DEA’s direct communication with the national authority of the importing country to confirm the authenticity of the foreign import permit. This verification ensures the proposed transaction is recognized and approved by the government of the destination country.

After the DEA validates the application, it will issue an official export permit to the exporter and also send the permit directly to the U.S. Customs and Border Protection office at the specified port of export. This ensures that when the shipment arrives for clearance, officials can match it to an approved permit.

Post-Approval and Record-Keeping Obligations

After the shipment has been exported, the U.S. exporter has follow-up reporting duties. The exporter must provide the DEA with return information confirming the details of the transaction, including the actual quantity shipped and the date it was exported. This reporting is handled through the DEA’s secure online portal.

Federal regulations also mandate record-keeping for all export transactions. Exporters are required to maintain complete records of each shipment for a minimum of two years. These files must be stored at the registered location and be readily available for inspection by DEA officials. Required records include:

• Copies of all application materials
• The official export permit
• Commercial invoices
• Shipping documents, such as bills of lading