Compliance Notes

by Anna Longwell, Esq.

Compliance Note: Drug Export

The Law

In 1996, Congress passed the FDA Export Reform and Enhancement Act. This law had several purposes, 1) Facilitate world trade, 2) Expedite FDA authorization to export, 3) Ease restrictions on export of unapproved FDA products, and 4) Satisfy foreign government requirements. It also empowered FDA to collect fees for providing certificates testifying to the legality of exporting products under FDA jurisdiction.

Basically, export is interstate commerce, and FDA has jurisdiction over health care products in interstate commerce. Prior to the new law, FDA had regulated the export of drugs under section 801 of the FDCA, and this portion of the law is still in effect. Under 801(e)(1), drugs intended for export are exempt from provisions of adulteration or misbranding if several conditions are fulfilled. These are 1) the product must comply with the specifications of the foreign purchaser, 2) it is not in conflict with law in the destination country, 3) the shipping carton is labeled “for export only”, and 4) the product is not intended for sale in the US. This provision does not exempt from 301(d), which prohibits shipping a drug requiring an NDA without an NDA. Drugs which do not require an NDA or ANDA (e.g. OTC drugs or rarely, grandfathered drugs) can be exported under 801 (e). Also, section 801(e) does not exempt from 301(p), which requires registration. What it did do was allow export of non-NDA drugs with foreign labels and foreign claims.

Drugs exported under this provision of the law have to have US labeling as well as the foreign labeling, and if the foreign labeling includes a condition of use not allowed in the US, the label must state this.

For NDA Drugs, prior to the 96 law, there were two ways to export, under section 802, and a provision for exporting partially processed biologics. All involved interaction with FDA and review. They are described in the now-outdated guidance ” A Review of FDA’s Implementation of the Drug Export Amendments of 1986″. This guidance could still be useful as an indication of FDA’s expectations for the content of permits to export drugs to non-listed countries.

The new law offered much simpler ways to export NDA and non-NDA products, and is set forth in new section 802. Briefly, an American manufacturer may export to any country if the product is approved in a listed country, and only notification to FDA is required. The manufacturer must maintain records, and the product must be labeled according to requirements of both importing country, and listed country. Such products cannot be adulterated because of “filth”, and must contain what the label says they contain, in the stated amount, and must be made in “substantial compliance” with US GMP, and/or ICH standards for quality. Additionally, the conditions for export of a non-NDA product listed in 801(e) must be fulfilled. A listed country is one which has controls recognized by Congress (or FDA), to ensure the safety of health care products sold within its borders. The law listed Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and EEA (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom), and it provides that FDA may add to this list.

Additionally, in section 802(c), product requiring a NDA for commercial US sale, but exported for investigational use, may be exported to listed countries in accordance with their law, without an IND. FDA has just published proposed regulations for export of IND drugs . When finalized, these regulations will be at 21 CFR 312.

If the unapproved drug does not have marketing approval in a listed country, there are two ways in which it may be exported, but both involve interaction with FDA. First, under 802(b)(2), the FDA can determine that the product has marketing approval in the destination country, and the destination country meets the requirements of a “listed” county. Additionally, the exporter can petition FDA for export, certifying that the drug would not meet conditions for NDA (or ANDA) approval in the US, and “credible scientific evidence” (this is NOT the “substantial evidence” of NDA fame) that the drug would be safe under its proposed conditions of use in the destination country. The petitioner must also supply FDA a request from a health authority in the destination country. The request has to include a statement showing the health authority understands that the product is not approved in the US, and is not approved in any “listed country”, and that they agree that the evidence provided is sufficient to show that the drug would be reasonably safe and effective in the destination country.

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