Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Perrigo disputes product-specific dosing devices

This article was originally published in The Tan Sheet

Executive Summary

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 Perrigo also disagrees with other elements of FDA's November 2009 draft guidance on dosing devices for liquid OTCs, including the recommendation that "delivery devices should not be significantly larger" than a liquid drug's largest labeled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)

Related Content

CHPA chimes in on OTC dosing device guidance





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts