Exports Under Section 802(b)(2)
Under the Federal Food, Drug, and Cosmetic Act (FDCA), there are provisions for exporting a drug, including certain biological drugs, for commercial distribution in another country when that drug is not approved in the U.S, depending on where else in the world the drug is approved. One of these provisions is section 802(b)(2) of the FDCA. If the unapproved drug is approved in another country that is not included in a list of countries identified in section 802(b)(1) of the FDCA (so-called “listed countries”), under section 802(b)(2) of the FDCA, the drug can be exported directly to that country if, among other requirements: 1) the drug complies with the laws of the importing country and it has a valid marketing authorization by the responsible authority in that country; and 2) FDA determines that the country has certain statutory and regulatory requirements.
The agency’s determination concerning the foreign country’s statutory and regulatory requirements may be applicable to subsequent exports if the foreign country’s statutes or regulations remain unchanged. Thus, FDA is making its decisions under section 802(b)(2) publicly available.
More information about exports under section 802(b)(2) of the FDCA is in the Guidance Document FDA-regulated Exports Under the FDA Export Reform and Enhancement Act of 1996. To date, FDA has only made one determination under 802(b)(2), which was with regard to the export of unapproved drugs to the Russian Federation. A copy of the letter making that determination can be found here.