On August 31, 2016, the Food and Drug Administration (FDA) published in the Federal Register a final rule [Docket No. FDA–2005–N–0464 (formerly Docket No. 2005N–0403)] amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs.
The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. The FDA is taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for the FDA. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.
The final rule contains some changes from the proposed rule, including revised definitions of the terms “active pharmaceutical ingredient,” “commercial distribution,” “content of labeling,” “importer,” “manufacture,” “private label distributor,” “relabel,” “repack,” and “representative sampling of any other labeling.”
The final rule is effective on November 29, 2016. See section IV of the Federal Register document for compliance dates.