FDA Posts Guidance on Drug, Biologics Exports

Rockville, MD (Aug. 14)-The US Food and Drug Administration announced the availability of a guidance document entitled “FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996” (Federal Register 72 (156), p. 45436).

The guidance document provides information about the statutory and regulatory requirements for exporting FDA-regulated products, including:

• General requirements for products exported under section 801 of the Act

• Labeling requirements for drugs and biologics exported under section 801(e) of the Act

• Export requirements for unapproved drugs, biologics, and devices under section 802(b) of the Act

• Exports of unapproved drugs and devices for investigational use

• Exports of unapproved drugs and devices in anticipation of foreign approval

• Exports of drugs and devices for diagnosing, preventing, or treating a tropical disease or disease “not of significant prevalence in the United States”

• Export notifications to FDA.

The guidance document finalizes the draft guidance entitled “FDA Guidance for Industry on Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996,” issued June 12, 1998, which aimed to facilitate understanding and compliance with the Act. Before the law was enacted, most exports of unapproved new drug products could be made to only 21 countries (identified in Section 802 of the Federal Food, Drug, and Cosmetic Act), and the exports were subject to various restrictions.

The Act amended Section 802 to allow the export of unapproved new drugs to any country, providing the drug complies with the laws of the importing country and has valid marketing authorization from Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, and countries in the European Union and European Economic Area.