Draft Guidance: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format

Draft Guidance: Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format

Today the U.S. Food and Drug Administration (FDA) is issuing the draft guidance Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format.The agency intends for this guidance to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 The recommendations in this draft guidance will help ensure that abuse, misuse, addiction, dependence and/or tolerance information in labeling is clear, concise, useful and informative, and, to the extent possible, consistent in content and format within and across drug and therapeutic classes. 

This draft guidance is one in a series of guidances FDA is developing, or has developed, to assist applicants with the content and format of labeling for human prescription drug and biological products.  In the Federal Register of January 24, 2006 (71 FR 3922), FDA published a final rule on labeling for human prescription drug and biological products.  The final rule is commonly referred to as the “Physician Labeling Rule” (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care providers.  The final rule and additional guidances on labeling can be accessed via FDA’s website.  The agency intends for the labeling requirements in these guidances to make information in prescription drug labeling easier for health care practitioners to access, read, and use.

FDA looks forward to receiving comments on this draft guidance through the associated docket 2019-14061.