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Package Inserts Explained

What is a Package Insert?

In 1938, Congress passed The United States Federal Food, Drug, and Cosmetic Act, which gave authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

This act of Congress stipulated that every drug product must have labeling consisting of “written, printed, or graphic matter” that is placed “upon the immediate container of any article” and that “bears adequate directions for use” and “adequate warnings.”

In the ensuing decades, the labeling information became the Package Insert, or Labeling Content; pharmaceutical manufacturing companies evolved to requiring that qualified, audited and approved specialty printers produce Package Inserts utilizing the same current Good Manufacturing Practices (cGMPs) required by the FDA of the drug manufacturers themselves.

In 2006, the FDA issued a major new regulation on Package Inserts. Below are all 18 elements of content listed in that 2006 regulation:

  1. Boxed Warnings
  2. Indications and Usage
  3. Dosage and Administration
  4. Dosage Forms and Strengths
  5. Contraindications
  6. Warnings and Precautions
  7. Adverse Reactions
  8. Drug Interactions
  9. Use in Specific Populations (pregnancy, pediatrics, geriatrics)
  10. Drug Use and Dependence
  11. Overdosage
  12. Description
  13. Clinical Pharmacology (how it works)
  14. Nonclinical Toxicology (other long term effects such as carcinogenesis or reducing fertility)
  15. Clinical Studies
  16. References
  17. How Supplied / Storage / Handling
  18. Patient Counseling Information (“information necessary for patients to use the drug safely and effectively)
    1. Any FDA-approved labeling such as Medication Guides or Patient Package Inserts must be reprinted with the Package Insert or accompany the labeling contents.

The Package Insert is written for healthcare providers, so-called “learned intermediaries” in legal language. Looking at the FDA’s requirements for useful CMI, as well as the criteria used in the studies by the University of Wisconsin and the University of Florida, shows that items 1 through 9, and 18, are all extremely relevant to patients. It is no surprise that many patients and caregivers do ask for and read the official Package Insert.