The US Food and Drug Administration (FDA) on Monday published a correction to a recent final rule on registering foreign and domestic manufacturing establishments, clarifying that a company producing solely products for investigational new drug (IND) applications is exempt from registration.

The more than 200-page final rule released in late August requires the electronic submission of the registration and listing information for all drug, active pharmaceutical ingredient (API), biological product and animal drug manufacturers, unless waived in certain circumstances, and describes not only how but when owners or operators must register their establishments with FDA and list the drugs they manufacture or process.

An FDA spokesman told Focus: “The recent FR correction notice was necessary because the preamble to the final rule incorrectly suggested that all manufacturers of investigational drugs are obligated to register.  Many of them, however, are exempt from registration under the exemption now codified in section 207.13(e), applicable to ‘manufacturers, repackers, relabelers, or salvagers who manufacture, repack, relabel, or salvage drugs solely for use in research, teaching, or chemical analysis and not for sale.’ 

“This would cover an establishment at which an IND drug is manufactured if that establishment does not engage in other activities that trigger the registration obligation and if the IND drug is not also marketed for regular prescription or nonprescription use.  Any establishment not sure about its registration obligation should check with FDA’s drug registration and listing staff,” he said.

Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs (Final Rule)