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.
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).
The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
