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“Label”Versus “Labeling” of a Drug: There is a Significant Difference

Moore, Daniel C. M.D.

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To the Editor:—
The Special Article by Landow et al.1 is informative. Unfortunately, it incorrectly intermingles the terms label and labeling. In part, it states: (1) “…the label (package insert)…”; (2) “…using a drug for an indication…a route of administration or a dose not described in the label is considered unapproved or ‘off label’ use”; (3) “The drug label serves two important functions: it present the indications for which a drug is approved and it summarizes safety and efficacy information obtained from clinical information conducted by the sponsor”; and (4) “Table 6. Contents of an Approved Drug Label.” In these statements, as well as others in the article, labeling—not label—is the correct term!
Pharmacologically, label and labeling are significantly different terms. The label is the information found on a vial or ampule of a drug as well as on its container. 2,3 It states only the contents of the container (e.g., milligrams per milliliter of the drug, its solvents, etc.), not how to use them safely. The labeling is the package insert. 2,3 It and the Physicians’ Desk Reference usually contain identical information. Before the passage of the Harris‐Kefauver Drug Amendments of 1962, the Pure Food and Drug Act of 1902 required only a label. 2 After passage of the Harris‐Kefauver Amendment (1962), labeling (description of the drug, indications and usage, contraindications, warnings, adverse reactions, and so forth), i.e., the safety of the drug, was required before it was approved for clinical administration. 2,3 The amendment to verify the safety of the drug was precipitated by the discovery that thalidomide, when administered during pregnancy, had caused phocomelia (fetal limb abnormalities) in several thousand infants. 2
Daniel C. Moore M.D.
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1. Landow L, Kahn RC, Wright C: FDA's role in anesthetic drug development. ANESTHESIOLOGY 1999; 90:882–9

2. Wilkerson CG, Pietrangelo MA: External controls, Principles of Pharmaceutical Marketing. Edited by Smith MC. Philadelphia, Lea & Febiger, 1983, pp 485–93

3. The Code of Federal Registration (CFR). Parts §200–299. Revised April 1, 1984. §201.55, §201.56, §201.57

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