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.
The Consumer Healthcare Products Association (CHPA) issued the following statement today following the introduction of S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act.
CHPA issued the following statement today following the introduction of S. 2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, sponsored by Senators Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.).
Today, the House Ways and Means Committee took an important step toward reinstating consumers’ ability to purchase OTC medicines with tax-preferred savings accounts, including FSAs and HSAs.
CHPA thanks Senator Isakson for his decades of service to the country and the U.S. Senate. We offer him our deepest gratitude for his steadfast dedication to better healthcare for millions of American consumers.
Today, the Consumer Healthcare Products Association (CHPA) issued the following statement upon submitting comments to the Food and Drug Administration (FDA) regarding its draft guidance titled, “Innovative Approaches for Nonprescription Drug Products.”
CHPA is pleased to see FDA’s long-awaited draft guidance on innovative approaches for greater consumer access to nonprescription medicines, and applauds FDA’s focus on patient safety as a top priority.
CHPA is pleased to see FDA’s long-awaited draft guidance on innovative approaches for greater consumer access to nonprescription medicines, and applauds FDA’s focus on patient safety as a top priority.
We are encouraged by the ongoing, bipartisan momentum behind this reform and look forward to seeing the legislation move forward in the House as well as the Senate.
