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  1. FDA Resources for Data Standards

Dosage Form and Route of Administration

ISO 11239 Dosage Form (DF) and Route of Administration (RoA) specifies data elements and structure that uniquely, and with certainty, identifies pharmaceutical dosage forms, units of presentation and routes of administration related to medicinal product.

FDA’s regional terminology for dosage form and route of administration is the FDA Terminology for Structured Product Labeling which is maintained by the National Cancer Institute / Enterprise Vocabulary Service. Some of the use cases for the FDA Terminology include: content of structured product labeling (package insert); drug registration and listing; and risk evaluation and mitigation strategies (REMS).

FDA Terminology is not compatible with the ISO 11239 standard for use in international IDMP. ISO 11239 and the ISO Technical Specification (TS) 20440:2016 specifies, for example, that the dosage form terminology has mandatory conformance characteristics that include:

  1. state of matter
  2. basic dose form
  3. release characteristics
  4. intended site
  5. transformation
  6. administration method

The FDA Terminology does not associate its terms with these characteristics.

For use in international IDMP and, specifically, for the generation of global Pharmaceutical Product IDs (PhPIDs), we will collaborate with ISO, as well as other regulatory agencies to identify and use a central list for dosage form and route of administration terms referenced in the ISO 11239 and ISO TS20440.