FDA Adopts Units of Measure Standard for Regulatory Submissions
The US Food and Drug Administration (FDA) on Friday announced its support for the latest set of Unified Code for Units of Measure (UCUM) codes for use in electronic submissions for drugs and biologics.“UCUM offers a single coding system for units of measure that does not contain ambiguities amongst electronic communication, and assigns a concise semantics to each defined unit,” FDA writes.
With the notice, FDA says it wants drugmakers to use UCUM coding for drug establishment registration, drug listing and in the content of product labeling in regulatory submissions to the Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).
The UCUM standard is a component of the Health Level 7 (HL7) units of measure developed under the Consolidated Health Informatics (CHI) and adopted by the Department of Health and Human Services (HHS) in 2005. The aim of the initiative was to develop and implement health information interoperability standards to make it easier to exchange electronic health information.
While FDA says it already supports the UCUM standard for structures product labeling (SPL) submissions, the agency says it will be updating the FDA Data Standards Catalog to reflect the standard’s immediate implementation. However, the agency notes that it “may consider further actions regarding the adoption of the UCUM standard and/or its implementation date” after receiving comments on the notice.
As of now the latest version of the FDA Data Standards Catalog from July 2019 does not list the UCUM standard as a supported or required standard, though FDA’s website offers a list of units of measure in the UCUM standard in its SPL resources.
Federal Register Notice