Prescribing Information (PI)
The official FDA-approved document for healthcare professionals that contains comprehensive information about a drug including indications, dosing, contraindications, warnings, adverse reactions, and clinical pharmacology. Also called the package insert or full prescribing information (FPI).
Technical Context
US PI structure (21 CFR 201.57): Highlights of PI (concise summary of most important information), Full PI sections: 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 — pregnancy, lactation, paediatric, geriatric, renal/hepatic impairment), 10 (Overdosage), 11 (Description — chemical structure, molecular formula, physical properties), 12 (Clinical Pharmacology — mechanism of action, PK, PD), 13 (Nonclinical Toxicology — carcinogenesis, mutagenesis, fertility), 14 (Clinical Studies — pivotal trial summaries), 16 (How Supplied/Storage), and 17 (Patient Counselling Information). The PI is a legally binding document — promoting a drug for uses, doses, or populations not in the PI constitutes off-label promotion.