The USPI is divided into Highlights of Prescribing Information, Table of Contents, and the Full Prescribing Information (FPI); and is often followed by Patient Information. If the product has a Medication Guide, it is provided as a separate document. Each part of the USPI follows a structured format to provide consistent relevant drug information to healthcare providers.
- Highlights of Prescribing Information
- Section 1: Indications and Usage
- Section 2: Dosage and Administration
- Section 3: Dosage Forms and Strengths
- Section 4: Contraindications
- Section 5: Warnings and Precautions
- Section 6: Adverse Reactions
- Section 7: Drug Interactions
- Section 8: Use in Specific Populations
- Section 9: Drug Abuse and Dependence
- Section 10: Overdosage
- Section 11: Description
- Section 12: Clinical Pharmacology
- Section 13: Nonclinical Toxicology
- Section 14: Clinical Studies
- Section 15: References
- Section 16: How Supplied/Storage and Handling
- Section 17: Patient Counseling Information
Many of the most important aspects of a drug can be quickly identified by reading the Highlights of Prescribing Information (Highlights), the first part of the Prescribing Information, which contains a concise and informative summary of crucial prescribing information; however, as this is a summary, it should not be used as a stand-alone document. Specific information in Highlights corresponds (and if provided electronically, may be hyperlinked) to more detailed information in the Full Prescribing Information (FPI).
Full Prescribing Information: Contents (Table of Contents)
The Table of Contents lists the sections and subsections of the FPI.
Full Prescribing Information
Clearly communicates information on the FDA-approved indications that are supported by substantial evidence of safety and effectiveness.
Provides the recommended dose, including the dosage range, dosing interval, usual duration, dosage modifications due to adverse reactions, recommended dosage in patients with renal or hepatic impairment if different from the dose from those with normal organ function, recommended dosage in patients taking other drugs with the potential for clinically important interactions, and instructions on how to safely prepare and administer the drug. For oncology drug products, this section may also provide information on tests to be performed prior to administration (e.g., companion or complementary diagnostic tests), premedications or concomitant medications required to ensure safe use, and a reference to information for special handling and disposal of cytotoxic drugs.
Provides information on the available dosage forms and strengths with a description of identifying characteristics such as shape, color, coating, scoring, and imprinting (when applicable).
Identifies the clinical situations for which specific concomitant diseases or conditions or prior medical history poses a risk that clearly outweighs any potential benefit of the drug. Such contraindications consider the seriousness of the underlying disease and the availability of alternative therapy.
Identifies and provides information on the most serious and clinically significant adverse reactions and other potential safety hazards. Detailed adverse reaction information (e.g., frequency and severity), discontinuation criteria, and recommendations to identify, manage or prevent these adverse reactions are generally provided.
Identifies adverse reactions (defined as undesirable effects reasonably associated with use of a drug) identified in clinical trials and postmarketing experience. The listing of common adverse reactions that are important for patient management decisions are typically provided in a tabular format. This section typically identifies the most common serious (including fatal) adverse reactions and the most frequent adverse reactions requiring dose interruption, reduction or discontinuation.
Describes clinically important interactions which may lead to an increased frequency or severity of an adverse reaction or decrease the effectiveness of a drug, and practical instructions to mitigate the risks of these interactions.
Includes important information related to administration of a drug during pregnancy and lactation, known effects on fertility, and available information about the pharmacokinetics, safety or effectiveness in pediatric or geriatric patients or those with renal and hepatic impairment. With implementation of the FDA Pregnancy and Lactation Labeling Rule, the information in this section is now standardized to ensure consistent content and format.
Conveys information about a drug’s potential for abuse, misuse, addiction, physical dependence, and tolerance to inform prescribing decisions for safe and effective use. This section is generally inapplicable and omitted from the labeling for oncology drug products; however, this section may be important for other drugs used to palliate cancer-related symptoms (e.g., pain) or manage adverse reactions associated with an oncology drug product (e.g., nausea/vomiting).
Provides human data (or laboratory or animal data) that describe the signs, symptoms and laboratory abnormalities occurring with drug overdosage, as well as recommendations on overdosage treatment. When no clinically meaningful information is available, this section may be omitted.
Includes the established pharmacological class, chemical name, structural formula, dosage form, route of administration, active and inactive ingredients, and other important physical or chemical information to assure safe use.
Details the mechanism of action, pharmacodynamic, and pharmacokinetic aspects essential to understanding dosing or information presented in other sections of the USPI.
Provides detailed information on carcinogenesis, mutagenesis, impairment of fertility and adverse events observed in animal studies that are important to understand clinical adverse reactions.
Section 14: Clinical Studies
This section provides a summary of the studies conducted to establish safe and effective use, including study design, patient selection criteria, a description of the population studied (e.g., patient and disease characteristics), and efficacy outcomes If applicable to healthcare providers making treatment decisions, relevant information on the outcomes in subpopulations are also summarized in this section.
For cytotoxic drugs, references to safe handling information are listed in this section.
Provides information on the dosage forms, strengths, NDC numbers, package quantities, and storage and handling conditions.
FDA-Approved Patient Labeling
Patient labeling may be physically attached or provided separately from the USPI and contains information in lay language that can help patients use a drug safely and effectively. Types of FDA-approved patient labeling include Patient Package Inserts (PPIs), Medication Guides (MGs), and Instructions for Use (IFUs). A Medication Guide must be provided to the patient whenever the drug is dispensed. FDA-approved patient labeling is important to help patients mitigate and avoid serious adverse reactions or medication errors.