Advertising Prescription Drugs

FDA's Rules and Regulations

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Requirements

Main Components:

  • must have the name of the drug
  • a minimum of one FDA approved use of the drug mentioned
  • most severe risks that the drug poses
  • In Reminder ads, the FDA must not include any claims or pictures about what the drug does or how it works.

“Physician Labeling Rule”

Physician Labeling Rule”, addresses prescription drug labeling that are used by prescribers and other Health Care Providers. The goal of the PLR format is to enhance the effective use of prescription drug products. These are what health care providers are using to make comprehending of prescription drugs easier and safer to access . The rule is part of FDA's initiative to manage the risks of medical product use .

" Pregnancy and Lactation Labeling Final Rule"

The "Pregnancy and Location Labeling Rule" requires change to the information and format in prescription drug labels in the "Physician Labeling Rule" . They are making changes to assist health care providers in the counseling of pregnant women and those whom are nursing that are in need of taking medication. Overall they are allowing the women to make educated decisions for themselves and their children. The PLLR requires labeling to be updated when the content becomes expired.

Below is a comparison of the current prescription drug labeling with the new PLLR labeling requirements.

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