Monograph Reform

The system that regulates most OTC medicines, the OTC Monograph System, was established in 1972. Although the system worked well for many decades, over the years it ground to a halt, making it difficult for FDA to update product labels with new safety information based on new science and data while also preventing the development of innovative products to meet consumer needs. On March 27, 2020, Congress included landmark legislation to reform the OTC Monograph system in the COVID-19 response bill, the CARES Act. OTC Monograph reform is a long-sought goal of CHPA, and has had broad stakeholder, FDA, and bipartisan/bicameral support.

CHPA member companies are undertaking an unprecedented effort to collectively help update the U.S. Pharmacopeia’s (USP) National Formulary (NF) monographs. The combined FDA/USP/CHPA Planning Committee is working on modernizing USP-NF monographs for small molecules and excipients to ensure all:

  • Utilize current technology;
  • Incorporate safety advancements; and
  • Address key quality aspects, such as impurities thresholds.

As part of USP's initiative to update and improve its monographs for drug substances and products in the USP–NF compendia, USP is focusing on monographs identified as a priority by FDA.

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Modern Regulation for Today's Marketplace

Recognizing the dire need for reform, FDA, public health stakeholders, and industry came together to drive historic change. As a champion and vocal advocate for OTC Monograph reform, the Consumer Healthcare Products Association (CHPA) strongly supported the bipartisan legislation — the Over-the-Counter Monograph Safety, Innovation, and Reform Act — that overhauled the system and will affect Americans for generations to come.

Read the Fact Sheet

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OTC Monograph Reform As Included in H.R. 748

Mar 27, 2020

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Timeline for an FDA Order to Determine a Drug is Not GRAS/E

Timeline for FDA consideration of changes to the general recognition status of an OTC monograph ingredient under the standard procedure

Oct 20, 2023

Browse Monograph Reform Content

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Press Releases and Statements

CHPA President & CEO Testifies Before Congress in Support of OTC Monograph Reform

CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use.

Sep 13, 2017

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Press Releases and Statements

CHPA Statement on House Passage of the Food and Drug Administration Reauthorization Act of 2017

CHPA congratulates the House of Representatives on the passage of the Food and Drug Administration Reauthorization Act of 2017.

Jul 12, 2017

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Press Releases and Statements

CHPA Statement on Status of Industry Efforts to Modernize the OTC Monograph System, Including Discussions on a User Fee Program

CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation.

Jul 12, 2016

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Submission

Comments to FDA: OTC Monograph Reform and User Fees

While the monograph system has served our nation well, it has become cumbersome and outdated and needs to be modernized.

Jun 14, 2016

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Press Releases and Statements

CHPA Statement on FDA Public Meeting on OTC Monograph User Fees

Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. We must define value differently than industries subject to FDA approval prior to marketing.

Jun 10, 2016

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Press Releases and Statements

CHPA Statement on FDA Announcement of Public Meeting on Over-the-Counter Monograph User Fees

CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.

May 10, 2016

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Press Releases and Statements

CHPA Speaks During FDA Meeting for Differin® Gel Switch Application

CHPA spoke today before a Food and Drug Administration Advisory Nonprescription Drugs Advisory Committee, during which the committee discussed data submitted by Galderma Laboratories, L.P. to support the supplemental new drug application for over-the-counter marketing of adapalene gel 0.1%.

Apr 15, 2016

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Submission

Comments to FDA: Formal Meetings Between FDA and Sponsors of PDUFA Products

CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”.

Jun 3, 2015

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Submission

Comments to FDA: OTC Drug Monograph System

CHPA applauds and is strongly supportive of FDA's re-examination of the monograph system in an effort to complete the OTC Drug Review.

May 8, 2014

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Submission

Over-the-Counter Drug Monograph System - Past, Present, and Future; Public Hearing

CHPA and its member companies strongly support the OTC Monograph System, which effectively and efficiently regulates the majority of OTC medicines on the U.S. market.

Mar 25, 2014

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On October 1, 2021, FDA released the ‘Annual Forecast for Planned Monograph Activities’, a nonbinding list, issued annually, describing planned monograph activities that FDA intends to address over the ensuing three years.

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Media Questions

CHPA Contact Mike Tringale Senior Vice President, Communications & Public Affairs mtringale@chpa.org 202.429.3520

Other Questions

Email OTCreform@chpa.org