USP aims to establish public quality standards for all Over-the-Counter (OTC) medicines bearing the U.S. Food and Drug Administration's (FDA) Generally Recognized as Safe and Effective (GRASE) designation that come to market through the FDA's development and approval process.
Recognizing a need for standards that ensure good quality, while simultaneously allowing OTC manufacturers the flexibility to innovate and improve upon their nonprescription products, USP plans to meet the challenge of developing and sustaining current monographs for multi-active ingredient drug products.
Interested in supporting or participating in this effort? Visit our Call for Candidates Web site to learn more.
Or, contact Sujatha Ramakrishna, Principal Scientific Liaison, Chemical Medicines, at 301-816-8349
Review USP's OTC activities to-date:
NOTE: Initiative Completed
The purpose of this Project Team will be to continue a dialogue between stakeholders and USP regarding the process and framework for modernization of USP-NF monographs for OTC drug substance and drug products.
Specifically, the Project Team will:
- Work with FDA to develop a better understanding of the legal requirements, goals and flexibility that the agency is willing to consider while modernizing the USP OTC drug substance and drug product monographs.
- Consider and provide feedback on the proposed USP class monograph approach, and suggest new or novel approaches (i.e. FDA guidance).
- Advise USP on prioritization of monograph revisions.
- Consider communication of OTC-related initiatives to industry, regulatory, and other stakeholders.
Evaluate quality standards for OTC products regulated under the FDA OTC monograph system for which there are no existing quality standards or those which could be modernized.
The Project Team will continue until completion of its charge, which may include development and implementation of a framework for OTC monograph modernization.
Acetaminophen 2, Expert Panel; modernization of acetaminophen-containing OTC drug products (2014–2016)
NOTE: Initiative Completed 2016
Address the modernization of acetaminophen-containing drug product monographs. Address the need to include a modern and comprehensive impurities test (e.g. other known impurities, unspecified impurities, and total impurities).
Acetaminophen Expert Panel; development and implementation of <227> p-aminophenol (PAP) in acetaminophen-containing drug products (2010–2014)
NOTE: Initiative Completed 2014
Address the limit for PAP in acetaminophen containing drug products. Develop a procedure for the control of this impurity at the established limit.
- Completed procedure development and validation for PAP at a limit of 0.15% in 37 drug product monographs.
- <227> 4-aminophenol in acetaminophen containing drug products
Visit our Pharmacopeial Forum page to learn more about the free online journal, and to register.
- <321> Drug Product Assay – Organic Chemical Medicines - Not official
- <323> Drug Product Assay – Inorganic Chemical Medicines - Not published
- <327> Drug Product Impurity Tests - Not official
- PF 39(1) entitled USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities
- PF41(1) Medicines Marketed under the Food and Drug Administration Over-the-Counter Drug Monograph System Regulations: Strategy for Developing Compendial Quality Standards
FDA Letters and USP Replies for modernization and improvement of OTC monographs
- Letter from Dr. Janet Woodcock, CDER, dated October 12, 2010
- Letter from FDA Monograph Modernization Task Group dated November 16, 2010
- FDA letter to USP dated August 22, 2011
- FDA letter to USP dated October 7, 2016
Other USP public comments on OTC System