USP Offers HHS Advice and Assistance

February 5, 2009
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

The United States Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration.

Rockville, MD (Feb. 5)-The US Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration. In a press release issued Feb. 2, 2009, USP said that chief executive officer Roger L. Williams sent letters to Tom Daschle, President Obama’s original choice to lead HHS (see related story), and Frank Torti, the acting commissioner of FDA. The letters outlined the areas in which USP could “offer scientific support and expertise as the new administration explores ways to better secure the nation’s supplies of medicines and foods.”

The letters cited recent contamination issues such as the heparin and melamine incidents of 2008 and noted that the “need for rigorous standards and practices is more urgent than ever,” according to the release. The letter to Torti specifically mentioned USP’s expertise in measurement science and how it could apply to FDA’s quality-by-design initiative. The letter to Williams discussed the goal of compendial harmonization.

Under the 1938 Food, Drug, and Cosmetic Act, all prescription and over-the-counter drugs sold in the US must comply with quality standards published in USP’s book of standards, the United States Pharmacopeia.

Click to view the letters to Daschle and Torti.