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.
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.
Letter to Dr. Shawn Dressman regarding U.S. Pharmacopeia's Stimuli article: USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities.
Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).
