Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

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)

You may also be interested in...



Perrigo disputes product-specific dosing devices

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 Perrigo also disagrees with other elements of FDA's November 2009 draft guidance on dosing devices for liquid OTCs, including the recommendation that "delivery devices should not be significantly larger" than a liquid drug's largest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

OTC Dosing Device Guidance Elicits Concern On Spoon Confusion, Added Cost

The Institute for Safe Medication Practices calls for FDA to make a draft guidance on dosage delivery devices for liquid OTCs more restrictive to prevent consumer misdosing via standardized devices

CHPA Adopts Dosing Guidelines For OTC Pediatric Liquids

The Consumer Healthcare Products Association recommends a standardized labeling format for OTC pediatric oral liquids to help prevent accidental overdoses and misdosing

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS103768

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel