In the August 31, 2016, Federal Register, FDA announced it is amending the regulations governing drug establishment registration and drug listing. The 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, which pertains to finished drug products and to active pharmaceutical ingredients, alone or together with one or more other ingredients, requires electronic submission of registration and listing information unless waived in certain circumstances. The final rule also describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments and list the drugs they manufacture or process. In addition, the rule makes changes to the National Drug Code system and supports: (i) implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and (ii) availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine. The rule is effective November 29, 2016.
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