FDA ISSUES NEW RULES FOR EXPORT NOTIFICATION, RECORDKEEPING
The U.S. Food and Drug Administration has issued final rules for notification and record-keeping for persons exporting drugs, biological products, devices, food or cosmetics from the United States.
“These regulations implement recent changes in the statutory requirements applicable to certain exports, and also codify record-keeping requirements for exports of products that cannot be marketed or sold in the United States generally,” the FDA said.
This rule, which complies with the FDA Export Reform and Enhancement Act, is effective March 19.
The act requires an exporter to provide a simple notification identifying the drug or device and the country to which such drug or device is being exported. A section of the act also requires persons exporting drugs or devices to maintain records of all drugs or devices exported under this provision, and to the countries where they are exported.
The countries included in this record-keeping are: Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa and the countries in the European Union and the European Economic Area. Currently, the EU countries are: Austria, Belgium, Denmark, Germany, Greece, Finland, France, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. The European Economic Area countries are the EU countries and Iceland, Liechtenstein and Norway.
The FDA said that it had considered comments submitted on the proposed rule when it prepared this final version.