For Industry

Pharmacologic Class

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.

In January 2006, FDA published a final rule [commonly referred to the “Physician Labeling Rule” (PLR)] that amended the requirements for the content and format of the prescribing information for human prescription drug and biological products. The PLR 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)].

The FDA EPC text phrases used in the Highlights Indications and Usage heading are included in the document entitled “FDA EPC Text Phrases for Highlights Indications and Usage heading” on the PLR Requirements for Prescribing Information website. 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:

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: 2.16.840.1.113883.3.26.1.5

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/ 
 

 

Page Last Updated: 08/18/2015
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