FDA Issues Prescription Labeling Draft Guidance

The draft guidance will help ensure the information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful, and informative.

The U.S. Food & Drug Administration has issued new draft guidance on labeling for prescription medicines.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 For example, the draft guidance recommends that terminology used in the Drug Abuse and Dependence section – such as abuse, misuse, addiction, physical dependence, and tolerance – be defined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A second draft guidance announced July 1, "Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination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.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • The Top 5 Safety and Technology Trends to Watch in 2020

    Get the latest on trends you can expect to hear more about in 2020, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • The 4 Stages of an Incident Investigation

    So, your workplace has just experienced an incident resulting in the injury or illness of a worker. Now what? OSHA recommends that you conduct investigations of workplace incidents using a four-step system.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - November December 2019

    November / December 2019

    Featuring:

    • GAS DETECTION
      Redefining Compliance for the Gas Detection Buyer
    • FALL PROTECTION
      Don't Trip Over the Basics
    • VISION PROTECTION
      What to Look for in Head-to-Toe PPE Solutions
    • PROTECTIVE APPAREL
      Effective PPE for Flammable Dust
    View This Issue