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.
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