The Over-the-Counter Monograph User Fee Program (OMUFA) modernized how FDA regulates most over-the-counter (OTC) medicines—making the 40-year-old system more efficient, transparent, and responsive to innovation. OMUFA was first authorized in 2020 through the bipartisan CARES Act, and it gave FDA critical resources to update safety information, reduce backlogs, and streamline the approval process for well-established ingredients. With OMUFA set to expire at the end of September 2025, timely reauthorization—OMUFA II—will continue this important progress and ensure Americans have access to safe, effective, and innovative OTC medicines.
In addition, 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 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 bipartisan legislation in 2020 that overhauled the system, which needs to be reauthorized by Congress every five years.
Today, the United States Senate Health, Education, Labor and Pensions (HELP) Committee approved S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act by a 22-1 vote.
CHPA released the following statement today by President and CEO, Scott Melville, applauding the introduction of The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use.
CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation.
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.
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.
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%.
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”.
