ePT--the Electronic Newsletter of Pharmaceutical Technology
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.”
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:
The guidance document finalizes the draft guidance entitled “FDA Guidance for Industry on Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996,” issued June 12, 1998, which aimed to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.
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