Issue Date: July 1, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products (21 CFR 201.57(c)(10)). , This guidance applies to: • Prescription drugs controlled under the Controlled Substances Act (CSA) • Prescription drugs not controlled under the CSA for which there is important information to convey to health care providers related to abuse and dependence
Download the Guidance Document
