The FDA is working with EVS to develop and support controlled terminology in several areas. More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt). This and other terminology used by FDA is updated and made available for download from an NCI File Transfer Protocol (FTP) site ¹. Listings of all FDA subsets in NCIt are available in tab-delimited text ², Excel spreadsheet ³, and zip-compressed Excel ⁴ formats. Relevant subsets are also available in each of these four main areas:

1. Structured Product Labeling (SPL) ⁵ is a document markup standard approved by Health Level Seven (HL7) ⁶, an international medical standards organization, and used by FDA to exchange medication information. The SPL standard specifies use of some 30 sets of controlled terminology. The NCI FTP site provides these SPL resources:

   • NCIt SPL Subsets ⁷: Eleven sets of SPL terminology are maintained in NCIt and available for download in Excel ⁸ or text ⁹ formats. SPL represents countries with ISO 3166-1 Alpha-3 country codes, extracted from NCIt in separate Excel ¹⁰ and text ¹¹ files.

   • NDF-RT SPL Subsets ¹²: The VHA National Drug File Reference Terminology (NDF-RT) maintains terminology used to code these medication properties:

     • Mechanism of Action (Excel ¹³ or text ¹⁴),
     • Physiologic Effect (Excel ¹⁵ or text ¹⁶), and
     • Structural Class (Excel ¹⁷ or text ¹⁸).

   • Problem List Subset ¹⁹: The Medical Condition component of SPL is coded with the VHA and Kaiser Permanente (VA/KP) Problem List Subset of the Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT). This set of SNOMED terms and codes is freely reusable worldwide without licensing or intellectual property restrictions. It is available in Excel ²⁰, zipped Excel ²¹, and text ²² formats, as well as through a specialized browser application ²³.

2. Unique Ingredient Identifier (UNII) ²⁴ codes are being developed by FDA to uniquely identify all ingredients used in marketed medications in the United States. Each UNII is assigned based on molecular structure, manufacturing process, or other characteristics. FDA provides a full set of published UNII codes ²⁵ on its Web site. These codes are also being included in corresponding NCI Thesaurus concepts, and files providing UNIIs with matching NCI concept codes are available for download in Excel ²⁶ and text ²⁷ formats.

3. Individual Case Safety Report (ICSR) terminology is used to encode adverse event information for reporting purposes. Fifteen ICSR term sets are maintained in NCI Thesaurus, and are available for download in Excel ²⁸ and text ²⁹ formats.

4. Center for Devices and Radiological Health (CDRH) ³⁰ terminology is under development to encode reporting of medical device problems. Three CDRH term sets, covering Patient Problem Codes, Device Component Codes, and Device Problem Codes, are maintained in NCIt and available for download in Excel ³¹ and text ³² formats.