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OTC Label Multiple Columns Suggested For Elongated Packaging By CHPA

This article was originally published in The Rose Sheet

Executive Summary

FDA should allow the use of more than two columns to present required information on OTC labeling for products with long rectangular packaging, Consumer Healthcare Products Association Senior VP and Director of Science & Technology William Soller, PhD, suggested at a June 29 "feedback" meeting on the OTC labeling final rule was held in Rockville, Md.

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OTC Label Exemptions With "Consistency In Format" May Be Allowed - FDA

Exemption requests from the OTC labeling rule may deviate from elements of the final requirements if they are consistent with the general format outlined in the reg, FDA's ODE V Director Robert DeLap, MD/PhD, said at a working group meeting on the issue in Rockville, Md. Sept. 17.

OTC Label Exemptions With "Consistency In Format" May Be Allowed - FDA

Exemption requests from the OTC labeling rule may deviate from elements of the final requirements if they are consistent with the general format outlined in the reg, FDA's ODE V Director Robert DeLap, MD/PhD, said at a working group meeting on the issue in Rockville, Md. Sept. 17.

OTC drug labeling format

Use of a two-column format in the "Warnings" section of OTC labeling would allow for more information in the "Drug Facts" section and may help solve some of the space problems created by FDA's final rule, the Consumer Healthcare Products Association says in a May 6 letter to the agency. "The use of columns is a significant space saver" and "definitely allows the standard format and the modified format to be used for more SKUs, thereby helping to limit the number of potential exemptions," CHPA says. The letter follows an April 23 "feedback" meeting ("The Rose Sheet" May 3, pp. 8-9). CHPA says it will provide the agency with a more detailed submission but requests a quick turnaround response. The Cosmetic, Toiletry and Fragrance Association is preparing separate comments

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