Drug Labeling

Article Author:
Michael Lopez
Article Editor:
Prasanna Tadi
4/20/2020 10:45:12 AM
PubMed Link:
Drug Labeling


On January 24, 2006, The Food and Drug Administration (FDA), an entity of the United States of Department of Health and Human Services, published a final rule on the content and format of labeling for human prescription drugs and biologics.[1][2][3] These regulations are within Title 21 of the Code of Laws of the United States of America. The term “drug labeling” in this article generally refers to any information provided with prescription drugs under the regulation of the FDA in the United States. The exact definitions of “drug” and “labeling” have been included from the U.S. Code of Laws. Under this law, the definition of a drug is: “(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)...” And label and labeling are defined as the following: “(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such an article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) A label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.”[3][4][5][6]

The FDA’s primary purpose of drug labeling is to ensure patient safety by giving healthcare professionals a summary of the safety and efficacy of a drug. The labeling is not aimed at a patient population because prescription drug administration is always under the supervision of a healthcare practitioner that is licensed to prescribe the medication.[7][8][9][10]

The following list is an outline of the requirements in a drug label:

  1. Highlights (a concise summary of label information)
  2. Full prescribing Information
  3. Limitations Statement 
  4. Product Names 
  5. Date of Initial U.S. Approval 
  6. Boxed Warning 
  7. Recent Major Changes 
  8. Indications and Usage 
  9. Dosage & Administration 
  10. Dosage Forms & Strengths 
  11. Contraindications 
  12. Warnings & Precautions 
  13. Adverse Reactions (listing of most common adverse reactions) 
  14. Drug Interactions 
  15. Use in Specific Populations 
  16. Patient Counseling Information Statement

Issues of Concern

Over 50% of medication use errors in terms of dosing, intervals, route of administration, etc.,  are associated with poor prescription drug labeling.[11] Although the FDA’s main purpose in drug labeling is to aid the healthcare provider. The patient’s misunderstanding of labeling is a major cause of mediation related morbidity, mortality, and cost. The most common reasons for medication use errors include name confusion and inability to read or understand prescription drug labels. Research has found that reduction in medication errors would occur if there were the implementation of patient-centered labeling with standardization of labeling text, scheduling, indication, language, typography, and other display standards. In general, these evidence-based recommendations focus on standardizing and simplifying medication labeling for patients to better self-manage their medication use.[11][12]

Clinical Significance

Medication error due to misunderstanding prescription drug labeling is the most common iatrogenic error leading to injury, hospitalization, and adverse medication reactions.[13] This problem is especially problematic in patients who have low health literacy or receive prescriptions for multiple medications.[14] In the United States, The Food and Drug Administration (FDA) is responsible for regulating and enforcing drug labeling to protect and ensure the safety and efficacy of prescription drugs. However, the FDA’s labeling requirements are not meant to be patient-centered. Currently, The United States Pharmacopeia (USP) has made recommendations based on the Institute of Health’s report on medical errors. The USP recommends patient-centered prescription labels, simplification of language, use of explicit text, the inclusion of purpose for the use, improved readability, labeling in a patient’s preferred language, supplemental information, and standardized directions for patients.[15]


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