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.
House and Senate negotiators are at odds over how to move forward with the FDA user fee reauthorization now that Senate HELP Committee Ranking Member, Senator Richard Burr (R-N.C.) is pushing a significantly pared-down version of the user fee reauthorization bill.
Now that the House of Representatives and the Senate HELP Committee have passed their respective FDA user fee bills, House and Senate negotiators have been working to conference and reconcile differences in both bills.
While this week both the House and Senate are on recess, last week the Senate HELP Committee began the process of meeting to discuss and ultimately pass the Prescription Drug User Fee Act (PDUFA).
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
The Senate HELP Committee will vote next Wednesday, January, 12, on whether to send Dr. Robert Califf’s nomination as FDA commissioner to the Senate floor for a confirmation vote.
