USP, FDA update quality standards for common drugs

The U.S. Pharmacopeial Convention is working with the FDA and the Consumer Healthcare Products Association to update the quality standards for common medicines. It's part of a USP plan to assess drug data in the USP and National Formulary compendia, with an eye toward updating test procedures to keep pace with technology. On the common-medication list is acetaminophen, among the highest-volume OTC drugs and also used in prescription meds.

The FDA has recommended a test for impurities and degradants in products containing the ingredient.

USP teaming with FDA and CHPA to apply modern test methods to acetaminophen, other common

As part of its ongoing mission to protect public health, the U.S. Pharmacopeial Convention (USP) is working with the Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) to update quality standards for widely used medicines and ingredients. Several years ago, USP put in place an ambitious, long-term effort to assess written (or documentary) standards for prescription and over-the-counter (OTC) drugs published in the United States Pharmacopeia and National Formulary (USP-NF) compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP's ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards.

The working relationships with FDA and CHPA fit into that overall initiative, focusing on an initial list of priority medicines and ingredients identified by FDA. The USP-NF provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by FDA in the United States. USP standards are used in more than 130 countries.

FDA Commissioner Margaret Hamburg, M.D., expressed support for USP's standards modernization project during her remarks at the USP Convention meeting in April of 2010, citing this effort as one of the most pressing tasks facing both USP and FDA given documented incidents of poor-quality prescription and OTC products. Updated test methodologies are crucial to help counter economically motivated adulteration (in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients), and also to address the challenge of impurities that may go undetected with older, non-specific assays and tests.

"FDA and USP have a long-standing partnership in law that helps ensure the quality of the American drug supply," said Roger L. Williams, M.D., USP's chief executive officer. "In the current effort, we are pleased to be joined by CHPA as well, as this initiative would not be possible without the active participation of industry. FDA has identified a number of medications and ingredients commonly used in prescription and OTC products that may be vulnerable to economically motivated adulteration or are associated with other concerns, which has helped focus our efforts. USP is working to make sure the quality standards for these products are based on the best current analytical procedures and allied reference materials to resolve such concerns. American patients, consumers and practitioners have a right to expect this."

In addition to the first list of products and ingredients for USP's priority attention, FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophen-one of the highest-volume OTC drugs and one that is also used in many prescription medications. Other commonly used ingredients to be updated include dextromethorphan (a cough suppressant) and diphenhydramine (an antihistamine).

USP will consider all recommendations for updates through its well-established process, in which volunteer experts evaluate standards, solicit commentary from the stakeholder community and ultimately decide on changes to incorporate. USP invites and encourages all stakeholders to provide input into the modernization initiative, and is seeking comment from manufacturers of products and ingredients included in the priority list of standards to be updated-as well as from the practitioner and consumer advocate communities.

FDA's priority list and background information on the standards modernization initiative may be found at www.usp.org/hottopics/monographs.html. Also on this Web page, USP has issued a call for volunteer experts for the Acetaminophen Monograph Expert Panel, which will provide recommendations for revisions to the Expert Committee.

NuSil Technology Acquires Pharmaceutical Antifoam (Simethicone) Business from Bluestar Silicones

Carpinteria, Calif. - NuSil Technology, a leading formulator and manufacturer of silicone compounds for the healthcare and pharmaceutical industries, announced a definitive agreement to acquire the pharmaceutical Antifoam (Simethicone) business from Bluestar Silicones effective 1-May-2009. As part of the acquisition, NuSil will begin transitioning the manufacturing of seven key Simethicone products used in pharmaceutical applications. Financial details of the transaction were not disclosed.

"The Bluestar Pharmaceutical Simethicone products are a great complement to the current NuSil Simethicone product line. NuSil's 30 years experience working with healthcare-related materials, including silicones for drug delivery systems and long-term implants, provides us with the working regulatory knowledge needed to support the product line for our customers," said Richard Compton, CEO and co-founder of NuSil. "This acquisition, when combined with our ingestible Simethicone product line that we acquired from GE Advanced Materials in 2004, strengthens our position in the pharmaceutical industry as a leading Simethicone supplier with a broad product offering and global distribution capabilities."

Simethicones are wide spectrum antifoam and defoaming products which have been used successfully in various industries including pharmaceutical, food and cosmetics. In the pharmaceutical industry, Simethicones have shown efficacy as antifoams in processes such as biological fermentations and in the manufacture of antibiotics. Simethicones are also widely used as active pharmaceutical ingredients in anti-flatulent formulations. NuSil's current Simethicone products meet various monographs including the European Pharmacopeia for Simethicone and the United States Pharmacopeia for Simethicone Emulsion (contact NuSil for specific references). As part of this acquisition, NuSil will transfer the manufacturing of the Bluestar Silicones Pharmaceutical Simethicone business to NuSil's FDA registered facility in Bakersfield, California.

NuSil formulates standard and customized silicone products based on the vast, unique array of properties the material provides. Product quality is assured by the company's Quality System, which begins with an effective design protocol and continues up the supply chain from vendor qualification through re-inspection of finished product inventories.

Workshop to update standards for metals in pharmaceuticals and dietary supplements

Rockville, Md., April 14, 2009 As part of a process to help ensure the protection of the public health, the U.S. Pharmacopeial (USP) Convention will hold a "Workshop on Metals in Pharmaceuticals and Dietary Supplements," April 28-29, 2009, at its headquarters in Rockville, Md. In addition to discussing limits for metals such lead, mercury, arsenic and cadmium, the workshop will explore the use of new procedures based on modern analytical methods that can better detect the presence of a range of metal impurities in medicines and dietary supplements. USP is hosting this workshop to give all interested parties the opportunity to provide feedback and perspective as these standards are revised.

USP is a nonprofit scientific organization that sets federally recognized standards for the identity, strength, quality and purity of prescription and over-the-counter medications, which are enforced by the Food and Drug Administration (FDA). These standards are contained in its compendia, the United States PharmacopeiaNational Formulary (USPNF). USP also sets widely recognized standards for dietary supplements and food ingredients.

USP's current standards for metal impurities are included in General Chapter Heavy Metals <231> of the USPNF. Pharmaceutical manufacturers in the United States are required to comply with the chapter's requirements in testing their products for various metal impurities. These standards have been in place for many years. However, as science has evolved to allow more sensitive and specific tests for the presence of metals, and understanding of the health implications of certain metals for humans has advanced, USP launched a revision of this chapter under the leadership of the organization's Council of Experts, its scientific-decision making body.

Humans are exposed to metals from a variety of sources, and they can occur naturally in the environment. In setting these new limits for metal impurities in medicines and supplements, USP is considering total potential exposure that humans have to these impurities from all sources including foods, water and air. This approach provides a broader view of the typical consumer's risk.

"This is a challenging and ambitious activity that will affect all manufacturers that market drug products in the United States, but it is also an important one that will serve public health by helping to maintain the quality of medicines that patients receive," said Darrell Abernethy, M.D., Ph.D., USP chief science officer. "At this workshop, we are seeking to agree upon methodologies and limits that provide appropriate patient protection but that also can be reasonably deployed across industry laboratories. I think we can do both, and look forward to discussing these issues with colleagues across the board at this workshop."

The workshop is one of many activities USP has engaged in to seek scientific input on this standards revision. During the summer of 2008, at the behest of USP, the Institute of Medicine (IOM) convened a two-day international meeting to foster a discussion on the state of scientific knowledge on the toxicity of metal impurities, the appropriate limits for these impurities and issues regarding revisions to USP testing methodologies. The workshop provided part of the basis for USP to advance specifications and standards for metals testing.