FDAs Final Guidance for Industry

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format

From the Background description: "On January 24, 2006, FDA published a final rule that amended the requirements for the content and format of labeling for human prescription drug and biological products (commonly referred to as the physician labeling rule (PLR)).3 This rule created a new required section in labeling entitled PATIENT COUNSELING INFORMATION (§ 201.57(c)(18)). The PATIENT COUNSELING INFORMATION section summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy)..."

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