FDA’s Draft Guideline for Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products

The US Food and Drug Administration (FDA) released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling.

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

The recommendations in this guidance 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. Applicants should follow the recommendations in this guidance when developing the DRUG ABUSE AND DEPENDENCE section for a new drug and when revising this section for a currently approved drug.

The section is composed of three subsections, described in depth in the draft: (1) Detailing if the drug is a controlled substance, if the DEA scheduling is still pending and what the active ingredient is; (2) Abuse, misuse and addiction information; (3) Dependence information, with information on physical dependence and withdrawal.

“Our goal is that this guidance will help ensure that information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful and informative,” Acting FDA Commissioner Ned Sharpless said in a statement that also points to the need for such clear labeling in opioid products.


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