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Alcohol warning petition

This article was originally published in The Tan Sheet

Executive Summary

Pharmaceutical Formulations asks FDA to add a variance procedure to the final rule requiring alcohol warnings on all OTC analgesics allowing manufacturers, "for good cause," to obtain additional time to re-label. In the Feb. 12 citizen petition, PFI says although it "is making a good faith effort to comply" with the April 23 deadline, it still has two-thirds of its inventory, or 546 labels, to revise in less than 70 days, and does not have the manpower to "thoroughly and adequately create, review and approve such a large volume of labels within such a short time frame." The petition points out FDA's suggested use of temporary stick-on labels initially "is not feasible" because "not all of PFI's customers" will permit such labels and "many product labels simply do not have room...without obscuring the other required information." PFI concurs with the Dec. 30 petition by Perrigo also seeking an extension mechanism ("The Tan Sheet" Jan. 25, p. 19)

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