Pharmacologic class is a group of active moieties that share scientifically documented properties and is defined on the basis of any combination of three attributes of the active moiety:
- Mechanism of Action (MOA)
- Physiologic Effect (PE)
- Chemical Structure (CS)
An FDA “Established Pharmacologic Class” (EPC) text phrase is a pharmacologic class associated with an approved indication of an active moiety that the FDA has determined to be scientifically valid and clinically meaningful.
The Physician Labeling Rule regulations require the following statement to appear under the Indications and Usage heading in the Highlights of Prescribing Information if a drug is a member of an EPC [see 21 CFR 201.57(a)(6)]:
(Drug) is a (FDA EPC text phrase) indicated for [indication(s)].
To find the FDA EPC text phrase for an approved active moiety click on the “Highlights of Prescribing Information” heading on the Prescribing Information Resources website and then find the “FDA EPC Text Phrases for Indications and Usage Heading in Highlights” document. The list is regularly revised to ensure that the most up-to-date FDA EPC text phrases are available to the public.
For more information about how FDA determines the EPC for a drug product, see:
- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information guidance
- MAPP 7400.13: Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information
Source: The codes are from the National Drug File Reference Terminology (NDF-RT) maintained by the Department of Veterans Affairs.
National Drug File Reference Terminology OID: 2.16.840.1.1138220.127.116.11.5
The full list of NDF-RT codes can be found on the NCI web site at: ftp://ftp1.nci.nih.gov/pub/cacore/EVS/NDF-RT/