United States Health Information Knowledgebase

 

Federal Drug Terminologies


Name:Federal Drug Terminologies
Type:Model View
Definition:A set of federal terminologies related to medications, including the Food and Drug Administration´s names and codes for ingredients, manufactured dosage forms, drug products and medication packages, the National Library of Medicine´s RxNORM for describing clinical drugs, and the Veterans Administration´s National Drug File Reference Terminology (NDF-RT) for specific drug classifications. NOTE: The CHI Medications group reviewed a large number of potential candidate terminologies for representing drug product information. One criterion, respect for existing regulatory authority, bears special mention. The Food and Drug Administration (FDA) is the United States regulatory authority for approving the safe and effective use of drug products in the US, and is collaboratively responsible for national and international harmonization of a number of drug-related issues. Product information, including the naming and coding of medications and their associated products, packaging, and other descriptive information is an FDA regulatory responsibility. The CHI medications group recommendations reflect this authority. While a number of medication-related terminologies include FDA determined and sanctioned names, selecting non-FDA terminologies as government standards would effectively usurp FDA´s legal role. The CHI recommended standards that are not solely administered by FDA, such as LOINC names for label section headers, have significant FDA input nonetheless. In addition, the CHI standards consensus process calls for approval by FDA (or any other federal agency with regulatory authority) prior to adoption or use of the standard. In essence, the consensus process used by CHI addresses the need for approval by all affected federal agencies.
Registration Authority:Centers for Medicare & Medicaid Services
Status:Recorded
Administrative Attributes
Responsible Organization:Centers for Medicare & Medicaid Services
Submitting Organization:Office of Clinical Standards and Quality
Steward Organization:Consolidated Health Informatics
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