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Understanding FDA Labeling Regulations

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  • Any written, printed or graphic material
  • Containing drug information
  • Disseminated by or on behalf of the manufacturer of that drug
  • For use by healthcare professionals
  • Claims must be consistent with prescribing information
  • No false or misleading statements or omissions
  • Materials must fairly balance benefits and risks
  • Substantiation
  • Labeling accompanied by prescribing information; ads must include “brief summary”
  • Appropriate business rationale
  • FDA issues
  • ACCME issues
  • AMA Guidelines on Gifts to Physicians
  • Fraud and abuse
  • Best price
  • Product liability
  • Lanham Act
  1. Contain a summary of the essential scientific information needed for the safe and effective use of the human prescription drug,
  2. Be informative and accurate and neither promotional in tone nor false or misleading, and
  3. Be updated when new information becomes available that causes labeling to become inaccurate, false, or misleading.
  1. Consistency with the FDA-Approved Prescribing Information
  2. Language and Readability
  3. Headings
  • Title
  • Product Title
  • Purpose Statement
  • Visual of Drug Product
  • For oral use only (take by mouth)
  • For subcutaneous injection only (inject directly under the skin)
  • For topical use only (apply on top of skin)
  • For products marketed under an NDA or ANDA, the name and place of business of the manufacturer, packer, and/or distributor.
  • For products marketed under a BLA, the name, address, and license number of the manufacturer (and, if included, the distributor).
  • The verbatim statement: This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • The month and year of initial FDA approval or revision of the IFU.
  • The liquid should be yellow and should have no lumps or particles.
  • You may see air bubbles. This is normal. If a patient needs to skip a specific step or set of steps that are not necessary for each dose, FDA recommends that the IFU refer the patient to the next appropriate step. If a patient needs to repeat a step or steps, FDA recommends that, if appropriate, the IFU refer the patient back to the listed step or steps (for example, “Repeat Steps 10 to 13 a second time, then continue to Step 14”).