FDA Issues Prescription Labeling Draft Guidance

The draft guidance will help ensure the information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful, and informative.

The U.S. Food & Drug Administration has issued new draft guidance on labeling for prescription medicines. Titled "Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products - Content and Format," the draft contains recommendations that represent FDA's current thinking on the content and format of this section for prescription medications that are scheduled under the Controlled Substances Act, as well as for prescription medications not scheduled under the CSA for which there is important information to convey to health care professionals related to abuse and dependence.

"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," the agency's news release states. For example, the draft guidance recommends that terminology used in the Drug Abuse and Dependence section – such as abuse, misuse, addiction, physical dependence, and tolerance – be defined in labeling to ensure common understanding, and FDA has included recommended definitions. The guidance says that a person who takes a friend's prescription opioid medication to relieve tooth pain is misusing the medication; if that person takes a friend's opioid to get a euphoric high, that use represents abuse of the medication.

A second draft guidance announced July 1, "Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format," relates to how the drug or biologic is used. Instructions for Use (IFU) is a type of labeling for patients who use products that have complicated or detailed patient-use instructions; it offers detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner and typically includes instructions on preparation, administration, handling, storage, and disposal.

The recommendations in the IFU guidance are intended to promote development of consistent content and format across IFUs.

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