Definition

Prescribing Information (PI)

Prescribing Information (PI) is the FDA-approved labeling for a prescription drug or biologic that tells health care professionals how to use it, covering approved indications, dosing, contraindications, warnings, adverse reactions and clinical study results.

2 min readReviewed September 14, 2026

Also known as: Package insert, Full Prescribing Information, Drug label, USPI

Key facts

Content and format rules
21 CFR 201.56 and 201.57
Current format
Physician Labeling Rule (PLR) format, final rule issued in 2006
Structure
Highlights, table of contents and 17 numbered sections
Pregnancy content
Narrative PLLR format replaced letter categories A, B, C, D and X
Electronic format
Structured Product Labeling (SPL), published on DailyMed

What is Prescribing Information?

Prescribing Information is the detailed professional label that the Food and Drug Administration (FDA) approves as part of a New Drug Application (NDA) or Biologics License Application (BLA). It is the document often folded inside the carton as a package insert, and it summarizes the evidence FDA reviewed when it found the product safe and effective for its labeled uses.

The text is agreed between the sponsor and FDA before approval and changes over time through supplements, for example when a new indication is approved or a new safety risk emerges. FDA can also require safety labeling changes under Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.

Prescribing Information is written for clinicians. Patient-directed labeling, such as Medication Guides, Patient Package Inserts and Instructions for Use, is separate, and over-the-counter drugs use the Drug Facts label instead.

How Prescribing Information is structured

Labels in the Physician Labeling Rule (PLR) format open with a half-page Highlights of Prescribing Information and a table of contents, followed by the Full Prescribing Information. A Boxed Warning, when required, comes first. The numbered sections are:

Older drugs that were never converted to the PLR format may still carry labels in the earlier, unnumbered format described in 21 CFR 201.80.

  • 1 Indications and Usage, 2 Dosage and Administration, 3 Dosage Forms and Strengths.
  • 4 Contraindications, 5 Warnings and Precautions, 6 Adverse Reactions, 7 Drug Interactions.
  • 8 Use in Specific Populations, including pregnancy, lactation, pediatric and geriatric use.
  • 9 Drug Abuse and Dependence, 10 Overdosage, 11 Description.
  • 12 Clinical Pharmacology, 13 Nonclinical Toxicology, 14 Clinical Studies.
  • 15 References, 16 How Supplied/Storage and Handling, 17 Patient Counseling Information.

Why Prescribing Information matters

The label defines what a product is approved to do, which shapes commercial and analytic work:

  • Manufacturer promotion is expected to be consistent with the approved labeling, so section 1 defines the promotable patient population.
  • Payers and pharmacy benefit managers often write prior authorization criteria that mirror the labeled indication, dosing and age limits.
  • Comparing labels across competitors shows differences in contraindications, boxed warnings and monitoring requirements that affect positioning.
  • The revision history of a label is a dated record of new indications and new safety findings over the life of a product.
  • Section 16 and the SPL file list the NDCs a label covers, which links clinical content to pricing and claims data keyed by NDC.

Sources

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