Magazine article Drug Topics

Reading between the Lines: Is Label Standardization Near?

Magazine article Drug Topics

Reading between the Lines: Is Label Standardization Near?

Article excerpt

The packages on drugstore shelves could soon look very different. After years of debate on this issue, the Food & Drug Administration and the nonprescription drug industry are taking steps to make OTC labels easier to read and understand. Standardization of this information could be just around the corner. The FDA published a rule in the Feb. 27, 1997, issue of the Federal Register proposing sweeping changes that would affect all drugs sold over the counter.

The 39-page proposed rule called for standardized headings and subheadings presented in a specified order and with specific graphic features, such as type size, spacing, capitalization, etc. It would allow manufacturers to simplify the presentation of labeling information by deleting specific terms that may interfere with clarity. It also would increase the number of interchangeable labeling terms manufacturers can use to make labeling language more concise and easier to understand and make warnings on OTC labels more intelligible. Perhaps the change most meaningful to pharmacists is the proposed inclusion of the suggestion to "ask your doctor or pharmacist" for more information. The FDA has given a June 27 deadline for comments on the proposed rule.

The Nonprescription Drug Manufacturers Association has been generally supportive of the proposed rule but does have some concerns. The association has been working for many years to simplify labels. In 1990, it voluntarily adopted a series of guidelines to improve label readability. In November 1995, the NDMA submitted recommendations to the FDA about making OTC labels more consumer-friendly.

"We are very pleased with the thrust of the proposal and look forward to working with the agency to conclude this process with a final rule that makes OTC labels even more consumerfriendly. We're still analyzing the details, but the proposal reflects virtually all of the major recommendations we submitted to FDA in November 1995," said NDMA president James D. …

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