HBW Insight 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

User Fees Could Chafe Cosmetics In OTC Monograph Reform Proposal

This article was originally published in The Rose Sheet

Executive Summary

Products marketed for cosmetic use but formulated with drugs are regulated as topical drugs and would be subject to potential OTC user fees, although the products have little similarity with oral or nasal delivery nonprescription drugs also available under FDA's monograph system, consultant David Steinberg says.

You may also be interested in...



Second Wind For OTC Monograph User Fee Legislation In House Hearing

House Health Subcommittee's “Modernizing FDA’s Regulation of Over-the-Counter Drugs” hearing Sept. 13 will "examine draft legislation to establish" a user fee program to support FDA's work on evaluating proposals for additions or changes to its nonprescription drug monographs.

Waiting For Congress: Reforming, Paying For FDA OTC Monograph Program

FDA officials emphasize that without legislation from Congress, the OTC monograph program is not changing, and without a user fee program, the agency couldn’t implement changes.

FDA Seeks $17.7m In User Fees For Mandatory Cosmetic Registration

Again in its budget justification, FDA signals that a Mandatory Cosmetic Registration Program does not come cheap. Legislation would be needed to implement the program, as well as the industry user fees required to support it, but only one cosmetics safety bill currently in play includes a user-fee mechanism to fund proposed facility and product registration with the agency.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS121189

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