Definition
Established Pharmacologic Class (EPC)
An Established Pharmacologic Class (EPC) is the FDA-recognized class name, such as Kinase Inhibitor or HMG-CoA Reductase Inhibitor, stated in the Highlights of a prescription drug's labeling and based on mechanism, physiologic effect or chemical structure.
2 min readReviewed September 14, 2026
Also known as: Pharmacologic class, FDA pharmacologic class, EPC text phrase, Drug class
Key facts
- Required in
- Highlights of Prescribing Information, 21 CFR 201.57(a)(6)
- Related class types
- Mechanism of action, physiologic effect and chemical structure
- Published through
- FDA pharmacologic class indexing of Structured Product Labeling
- openFDA fields
- pharm_class_epc, pharm_class_moa, pharm_class_pe, pharm_class_cs
What is an established pharmacologic class?
When a prescription drug label uses the current prescribing information format, the Highlights section names the drug's established pharmacologic class in its indications statement, for example a statement that a drug is a kinase inhibitor indicated for a particular cancer. The EPC tells prescribers what kind of drug it is in a few words.
The FDA treats a class as established when it is scientifically valid and clinically meaningful. The EPC is drawn from whichever mechanism of action, physiologic effect or chemical structure concept best describes the drug, and some drugs carry more than one EPC.
How EPC classification works
Pharmacologic class data follow a defined indexing process:
- Indexing: the FDA indexes labeled drugs with pharmacologic class concepts, including an EPC and, where relevant, mechanism of action, physiologic effect and chemical structure terms.
- Consistency: the FDA publishes the indexing so the same class phrase is reused across labels for drugs in that class.
- Multiple classes: combination products and some single agents carry more than one EPC.
- Distribution: the indexing is released with Structured Product Labeling data and exposed in openFDA as pharm_class_epc and related fields.
Why established pharmacologic class matters
EPC gives analysts a regulator-defined grouping of drugs:
- Competitive sets: EPC groups competing products, such as all GLP-1 receptor agonists, without building a custom taxonomy.
- Cross-source joins: class fields in openFDA link drug labels, adverse event reports and recall records by class, where those records carry openFDA annotations.
- Market analysis: class-level views of pricing, shortages and prescribing reveal substitution options that ingredient-level views miss.
- Coverage gaps: not every product is indexed, and older labels without a Highlights section may lack an EPC.
EPC vs other drug classification systems
EPC is an FDA labeling classification. The World Health Organization Anatomical Therapeutic Chemical (ATC) system classifies drugs by organ system and therapeutic use, and the USP Medicare Model Guidelines group drugs into categories and classes that CMS uses when reviewing Medicare Part D formularies. The systems often disagree, so pick one per analysis and state which.