Export reg delayed
This article was originally published in The Tan Sheet
Executive Summary
Effective date of new notification, recordkeeping requirements for exported drugs, foods, cosmetics and devices that cannot be sold domestically has been postponed for three months until June 19, FDA says in March 18 letters to CHPA, CTFA, Chicago law firm Sandler Travis & Rosenberg. 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. Associations, law firm petitioned FDA for a six-month stay, arguing companies needed more time for compliance (1"The Tan Sheet" March 18, 2002, p. 18)...