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Export reg delayed

This article was originally published in The Rose Sheet

Executive Summary

Effective date of new notification, recordkeeping requirements for exported drugs, foods, cosmetics and devices that cannot be sold domestically postponed three months until June 19, FDA says in March 18 letters to CHPA, CTFA. Reg's provisions originally were slated to take effect March 19. Agency says it will "exercise enforcement discretion and not generally take enforcement action regarding the final rule" until publication of a Federal Register notice staying the effective date. Trade associations, Chicago law firm Sandler Travis & Rosenberg petitioned FDA for a six-month stay, arguing companies needed more time for compliance (1"The Rose Sheet" March 18, 2002, p. 7)...
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