General

Labeling

All written, printed, or graphic matter on or accompanying a drug or device, including the package insert and promotional materials.

Usage Examples

The labeling update added a new safety warning.
Promotional labeling must be consistent with the PI.
PLR format standardized prescription drug labeling.

What is Labeling?

Labeling encompasses all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. This includes the approved prescribing information (package insert/PI), patient labeling, and promotional materials.

The prescribing information contains comprehensive drug information including description, clinical pharmacology, indications, contraindications, warnings, precautions, adverse reactions, drug interactions, dosage, and how supplied.

Labeling must be accurate and not misleading. Changes require FDA approval through supplements or may be implemented through specific mechanisms like CBE-0 (Changes Being Effected) for certain safety updates.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 201, 21 CFR 314 70.

FDAICHHealth Canada

When This Matters

The labeling update added a new safety warning.
Promotional labeling must be consistent with the PI.
PLR format standardized prescription drug labeling.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

21 CFR 20121 CFR 314 70

Frequently Asked Questions

Physician Labeling Rule (PLR) format is the standardized structure for prescription drug labeling, including Highlights section, Table of Contents, and standardized section ordering.

Through supplements to the NDA/BLA. Prior Approval Supplements (PAS) require FDA approval before implementation. CBE supplements allow implementation before approval for certain changes.