Monograph Modernization History

Summary: USP Over-the-Counter (OTC) Drug Substances and Drug Products Workshop, September 8–9, 2011

• Top officials from the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and the U.S. Pharmacopeial Convention (USP) expressed the need for modern scientific standards to help ensure the quality of over-the-counter (OTC) monograph medicines and their ingredients at a workshop, September 8-9. The workshop was attended by 187 people, representing 41 organizations.
• Opening the workshop, Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, noted that the public expects the same quality of OTC medicines as it does of prescription medicines. Having enjoyed a high-quality drug supply, Americans expect to encounter no problems with the medicines they take, and, collectively, "we have an obligation to keep it that way," she said.
• Representing the nation's manufacturers of OTC products, Mr. Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), pointed out that quality is critical given the prevalence of these medicines in the marketplace. Touching "millions of consumers each and every day," six of the 10 most widely used medicines are OTC products. He noted that "safe and effective products stem from sound science," and that this science does indeed evolve over time.
• The workshop was preceded by a specially developed USP Pharmacopeial Education class, covering key aspects of the compendial process, by which USP public standards are developed and updated. Forty-four workshop attendees also participated in the class.
• A USP Press Release covering the workshop includes a video interview with Dr. Woodcock.
• Additionally, a Workshop Summary includes highlight slides from the workshop speakers and the panel discussions.

Call for Povidone Methods
Posting Date: 26–Aug–2011
Closing Date: 17–Oct–2011

Concurrent with USP's Call for Candidates for the Povidones Expert Panel effort, USP invites industry to submit methods pertaining to Povidones. USP may also hold a public open microphone meeting to discuss these methods. All methods and discussions will be provided to the Povidones Expert Panel for their consideration. The expert panel is expected to be formed by October 10, 2011.

FDA issued a guidance document entitled "Pharmaceutical Components at Risk for Melamine Contamination" on August 6, 2009. In an effort to keep both FDA and stakeholders informed of USP's activities in this matter, USP launched a "Hot Topics" Web page on Pharmaceutical Components at Risk for Melamine Contamination. USP has offered to collaborate with FDA and industry stakeholders toward the development of appropriate analytical methods in order to address the concerns about economically motivated adulteration.>

To participate in this collaboration, send proposed Povidone methods to Kevin Moore, Ph.D. at ktm@usp.org.

For additional information, contact Kevin Moore, Ph.D., Senior Scientific Liaison, Excipients at ktm@usp.org or 301-816-8369.

Call for Candidates: USP Expert Panel on Povidones
Posting Date: 26–Aug–2011
Closing Date: 17–Oct–2011

USP invites qualified candidates to apply to serve as scientific experts on the Povidones Expert Panel. The current Povidones Nitrogen assay method (<461> Nitrogen Determination (by Kjeldahl method)) is non-specific. FDA prefers a more specific assay method due to concerns about economically motivated adulterants (e.g., melamine). USP will also initiate a separate Call for Methods to obtain all methods from industry and potentially hold a public, open microphone meeting to discuss methods.

The purpose of this Expert Panel is to review, evaluate, and generate proposals, procedures, and data for the replacement method to the Nitrogen Assay method in the three Povidone monographs (Povidone, Crospovidone, and Copovidone), in support of USP's monograph modernization initiative. The Expert Panel will make recommendations to and work at the direction of the Monographs—Excipients Expert Committee. Candidates interested in sharing their time and expertise should have in-depth knowledge of:

• Povidones testing
• Procedure development and validation
• Compendial procedures

Register now to participate in the Over-the-Counter (OTC) Drug Substances and Drug Products Workshop that will be held on September 8 & 9, 2011 at USP–U.S. in Rockville, MD. This workshop is co-sponsored by the U.S. Food and Drug Administration (FDA) and USP.

The keynote speaker at this event will be Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research (CDER). Mr. Scott Melville, CEO of the Consumer Healthcare Products Association (CHPA), will be a featured speaker.

The workshop will be preceded by a USP Pharmacopeial Education course, "Understanding the USP Compendial Process," which is open for registration to workshop attendees at a reduced rate. More information on this offering is also available at the above link.

Call for Candidates: USP invites qualified candidates to apply to serve as scientific experts on the Talc Expert Panel. The purpose of this Expert Panel is to review, evaluate and generate proposals, procedures and data for the test for Absence of Asbestos in the Talc monograph in support of USP's monograph modernization initiative. The Expert Panel will make recommendations to and work at the direction of the Monographs—Excipients (EXC) Expert Committee. Candidates interested in sharing their time and expertise should have in-depth knowledge of:

• Asbestos testing
• Procedure development and validation
• Compendial procedures

USP anticipates establishing the Expert Panel by May 1, 2011. Most of the work of the Expert Panel will be conducted via teleconference at a frequency to be determined. It is likely that there will be at least one face-to-face meeting at USP during the lifetime of the Expert Panel.

Monograph Modernization Web Meeting: The USP live web meeting on the monograph modernization initiative was held on February 25, 2011. There were over 100 participants representing about 70 organizations from the US and around the world. The meeting featured speakers from USP, FDA and CHPA and covered the following topics:

• Overview of the monograph modernization initiative
• Current status
• Strategies for modernization
• FDA priority monographs
• Stakeholder participation

Links to the presentations and a recording of the full webcast of the session are provided below.

1. Presentations from the February 25, 2011 web meeting
2. Recording of the February 25, 2011 web meeting [Recording currently unavailable]

Call for Candidates: USP is issuing a call for candidates to serve on an Acetaminophen Expert Panel to be established by May 1, 2011. The members of the Panel will review, evaluate and generate proposals, procedures and data for the modernization of acetaminophen-containing dosage form monographs (e.g., tablets, capsules, oral solutions) and provide recommendations to the relevant Expert Committee(s).

USP is seeking individuals with expertise in the following areas:

• Procedure development and validation
• Acetaminophen dosage forms/formulations (solid oral and oral liquids for single and/or multi-active products)
• Compendial procedures

Save the Date: Sept 8 & 9, 2011. USP is organizing an OTC Workshop at USP–U.S. in Rockville, MD. Further details will be posted on this Hot Topics page.

As part of USP's initiative to update and improve its monographs for drug substances and products in the United States Pharmacopeia and the National Formulary (USP–NF) compendia, USP is focusing on monographs identified recently as a priority by the U.S. Food and Drug Administration (FDA). USP is seeking active input from industry in this monograph modernization initiative via a live Open Microphone Web Meeting on Friday, February 25, 2011, 1:00 to 3:00 p.m. ET. See update on March 23 for webcast recording.

USP received an October 12, 2010 letter from FDA emphasizing th importance of up-to-date monographs and encouraging USP to continue its monograph modernization efforts. A subsequent November 16, 2010 letter to USP from FDA listed USP monographs for acetaminophen and diphenhydramine and for several related dosage forms as high priority for FDA for updating. Most of these monographs assist in controlling the quality of over-the-counter (OTC) medications. The letter also identified as high priority NF monographs for copovidone, crospovidone, povidone and talc for updating. The October 12, 2010 and November 16, 2010 FDA letters and USP's November 23, 2010 and December 20, 2010 responses are available below.