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  4. Human Drug Exports
  5. Export Requirements for Unapproved Drugs
  1. Human Drug Exports

Export Requirements for Unapproved Drugs

Exporting Unapproved Drugs
Drugs made in the U.S. are not always approved by FDA but may be approved by regulatory authorities in other countries. Exporters must comply with U.S. federal law when exporting drugs the agency has not reviewed for safety, effectiveness or quality.

Section 802 of the Federal Food Drug and Cosmetic Act (21 USC § 382) allows unapproved human drugs to be exported to any country if the drug complies with the laws of the importing country and has valid marketing authorization from listed countries. The listed countries are Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa and the countries in the European Union (EU) and the European Economic Area (EEA).

Export Notifications for Unapproved Drugs
The FD&C Act also authorizes FDA to receive notification for the export of certain unapproved human drugs. The agency processes this export document, which is called an export notification letter or simple notification.

Homeopathic Products
Homeopathic products must conform to the requirements for unapproved drug products under section 802 of the FD&C Act. The agency has deployed a new functionality in the export certification and tracking system, CDEReCATS, to issue unapproved electronic certificate of pharmaceutical product (eCPP) for homeopathic products under the blue ribbon designated for these types of eCPPs.

Homeopathic products must meet the same requirements as other unapproved drug products to obtain an eCPP.  To obtain an unapproved drug eCPP, applicants must meet the relevant requirements of sections 801(e)(1) and 802 of the FD&C Act. This includes providing evidence that the product intended for export is not sold or offered for sale in the U.S.

Applicants may request an eCPP using CDEReCATS. Please refer to the human drug export certificate application instructions page for more details on how to request an eCPP.

If your company submitted an eCPP application for a homeopathic product that is currently pending review with the agency and your company is still interested in receiving an eCPP, please resubmit the application with the required information for our review.

Outsourcing Facilities
Compounded drugs are not FDA-approved. If an importing country requires an export certificate for a compounded drug product, entities may request a certificate. FDA will evaluate these requests on a case-by-case basis.

Exports Under Section 802 of the FD&C Act
The FD&C Act requires an exporter of a drug to provide a simple notification to the agency that identifies the drug and the country it is being exported to when the exporter begins to export. This requirement applies to listed and non-listed countries.

The FD&C Act also requires the exporter maintain records of all drugs exported and the countries to which they were exported.

Simple Notification
Companies may request an export certificate if an importing country requires an export certificate for an unapproved drug. FDA evaluates these requests on a case-by-case basis and may issue an export certificate if certain requirements are met.

The agency does not require a company to obtain written permission prior to export. However, companies must provide written notification (also known as a simple notification) to FDA (pursuant to 21 CFR 1.101(d)) when the exporter begins to export the drug.

  • The human drug product's trade name
  • The human drug product's abbreviated or proper name
  • The description of the human drug product's strength and dosage form
  • The country that is to receive the exported drug if the export is to a non-listed country under section 802 of the FD&C Act

The simple notification may identify the country receiving the drug if the export is intended for a listed country, or the notification may state the export is to a listed country without identifying the listed country.

Submit simple notifications using CDER Export Certification Application and Tracking System (CDEReCATS) as follows:

  • CDEReCATS may be accessed by logging into the FDA Industry Systems (FIS) using the establishment’s FDA Unified Registration and Listing Systems (FURLS) account ID and password to log in.
  • Select “CDEReCATS” from the list of systems available on the FURLS homepage.
  • Select “Enter New Application/Export Notification” from the list of options. The system will display a screen allowing you to submit an Export Notification letter.

Detailed instructions for submitting an export notification/simple notification can be accessed on the CDEReCATS External User Guide.

Contact
CDERexports@fda.hhs.gov

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