Drugs

Labeling Abuse and Dependence Guidance

FDA has published a draft guidance, Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products—Content and Format, to assist applicants in writing the Drug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. The document applies to prescription drugs controlled under the Controlled Substances Act and prescription drugs not controlled under the Controlled Substances Act for which there is important information to convey to healthcare providers related to abuse and dependence.

The guidance discusses and provides recommendations on:

general principles to consider when drafting the Drug Abuse and Dependence section of labeling;
what information to include in the Drug Abuse and Dependence Section, including common terminology and definitions related to abuse and dependence;
how to write, organize, and format the information within the Drug Abuse and Dependence section; and
how information related to topics presented in the Drug Abuse and Dependence section should be distributed elsewhere in labeling.

FDA says the guidance recommendations are intended to help ensure that the Drug Abuse and Dependence section is useful, informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.

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