Investigational Drug Establishments Not Required to Register, FDA Says

The Food and Drug Administration is correcting a final rule it issued in August to clarify drug establishment registration requirements for manufacturers of investigational drugs, it said (here). The original final rule setting electronic registration requirements for human and animal drug and biologics establishments included an incorrect statement that establishments that make investigational drugs must register. FDA now says “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 are exempt from the establishment registration requirement” if they’re not required to register due to other activities.