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FDA OTC Labeling Guidance Allows Flexible Approach To Template Use

This article was originally published in The Tan Sheet

Executive Summary

OTC drug manufacturers that choose to employ FDA's "Drug Facts" labeling templates do not have to follow them verbatim, the agency says in a guidance published in the Oct. 18 Federal Register

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Small business labeling guidance

Draft guidance titled "1Labeling OTC Human Drug Products (Small Entity Compliance)", published in the Federal Register Dec. 9, is an effort "to help small businesses better understand the new over-the-counter labeling requirements and to prepare new labeling within the prescribed implementation compliance dates," FDA says. This is the third guidance the agency has issued on "Drug Facts" labeling, following one on ANDA labeling and another on column formats (2"The Tan Sheet" Oct. 21, 2002, p. 5). The draft "describes how to list those inactive ingredients that are different when a finished OTC drug product is obtained from multiple suppliers," the agency notes...

Small business labeling guidance

Draft guidance titled "1Labeling OTC Human Drug Products (Small Entity Compliance)", published in the Federal Register Dec. 9, is an effort "to help small businesses better understand the new over-the-counter labeling requirements and to prepare new labeling within the prescribed implementation compliance dates," FDA says. This is the third guidance the agency has issued on "Drug Facts" labeling, following one on ANDA labeling and another on column formats (2"The Tan Sheet" Oct. 21, 2002, p. 5). The draft "describes how to list those inactive ingredients that are different when a finished OTC drug product is obtained from multiple suppliers," the agency notes...

Small business labeling guidance

Draft guidance titled "1Labeling OTC Human Drug Products (Small Entity Compliance)", published in the Federal Register Dec. 9, is an effort "to help small businesses better understand the new over-the-counter labeling requirements and to prepare new labeling within the prescribed implementation compliance dates," FDA says. This is the third guidance the agency has issued on "Drug Facts" labeling, following one on ANDA labeling and another on column formats (2"The Tan Sheet" Oct. 21, 2002, p. 5). The draft "describes how to list those inactive ingredients that are different when a finished OTC drug product is obtained from multiple suppliers," the agency notes...

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