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CHPA chimes in on OTC dosing device guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA's guidance on dosage delivery devices for liquid OTCs should adopt some measures from the Consumer Healthcare Products Association's voluntary industry guidelines on the subject, the trade group says. Among the recommendations in a Feb. 2 1letter, FDA should make milliliter the preferred primary unit of liquid measure, as CHPA says its member companies did. This echoes a change suggested by the Institute for Safe Medication Practices in a recent comment to the agency (2"The Tan Sheet" Feb. 1, 2010). CHPA also encourages FDA to limit spoon measures to either "teaspoonful" or "tablespoonful" to reduce confusion, and to tell firms to limit text on a dosing device that "risks obscuring important liquid measure markings." CHPA added dosing device language to its voluntary guidelines in November 2009 (3"The Tan Sheet" Dec. 7, 2009)

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FDA's recommendation that industry package liquid OTCs with uniquely appropriate dosing devices "may in fact lead to an increase in dosing errors" as consumers mix devices from different products, private labeler Perrigo says. The firm's associate director of regulatory affairs, Devon Morgan, writes in a Feb. 3 1letter that FDA should study consumer usage and understanding, and then provide "data-driven direction to industry." Perrigo also disagrees with other elements of FDA's November 2009 draft guidance on dosing devices for liquid OTCs, including the recommendation that "delivery devices should not be significantly larger" than a liquid drug's largest labeled dose; the firm cites a device's need to facilitate technical functionality and consumer handling. Allegan, Mich.-based Perrigo distributes 63 liquid OTC products and says it is implementing the voluntary industry dosage device provisions adopted by the Consumer Healthcare Products Association (2"The Tan Sheet" Feb. 8, 2010, In Brief)

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