FDA Corrects Rule to Exempt Manufacturers of Certain INDs from Registration

Manufacturers of investigational new drugs intended for research, teaching or chemical analysis do not have to register their establishments with the FDA, according to a revised final rule on the electronic registration of foreign and domestic facilities.

These establishments are exempt from registration as long as they do not sell the IND or engage in other activities that would require them to enlist their facility with the FDA. The corrected final rule removes a statement that suggested all IND manufacturers have to register their establishments.

The FDA first released the final rule that requires manufacturers to electronically submit, list and register information on their facilities, finished drug products and active pharmaceutical ingredients in August.