FDA Updates Drug Establishments Registration Rule

The FDA Aug. 31 issued a final rule for drug manufacturers on registering establishments and submitting drug lists.

Drug manufacturers are required to register with the FDA annually. Among other things, the registration identifies establishments for FDA inspections. Each registered establishment also must submit a list of drugs that it manufactures.

The Food and Drug Administration’s final rule (RIN:0910–AA49), announced in an Aug. 31 Federal Register notice (81 Fed. Reg. 60,170), is intended to improve the management of drug establishment registration and drug listing requirements and “make these processes more efficient and effective for industry and for us,” the agency ...