FDA has released its draft guidance, Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format. The document gives guidance on the development of patient counseling information on labels has required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The guidance is intended to assist applicants with deciding what topics to include in a label’s patient counseling information section as well as the presentation and organization of those topics.
A final rule amending requirements for the content and formatting of labeling, published on Jan. 24, 2006, created the new required section, Patient Counseling Information (§ 201.57(c)(18)). The section summarizes the information that a healthcare provider should convey to a patient. According to the draft guidance, patient-counseling information must contain information necessary for patients to use the drug safely and effectively and, if applicable, reference to FDA-approved patient labeling.