Regulatory and Association News

Feb 28, 2007
By PharmTech Editors

The latest regulatory and association news for pharmaceutical manufacturers and contract manufacturing organizations.

InformexUSA, San Francisco (Feb. 14)The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC, http://www.socma.org/) is launching a new sustainable chemistry initiative, the International Center for Sustainable Chemistry.SOCMA is the US-based trade association of batch and custom manufacturers, including contract manufacturing organizations supplying active pharmaceutical ingredients and intermediates to the pharmaceutical industry.

The International Center for Sustainable Chemistry is the result of a partnership and memorandum of understanding between SOCMA and the US Environmental Protection Agency (EPA, DC, http://www.epa.gov/). The EPA will serve a technical advisory role in the new center, which will act as an industry conduit for green-chemistry outreach and activities.

Washington, DC (Feb. 7)— The Synthetic Organic Chemical Manufacturers Association (SOCMA, http://www.socma.com/) submitted comments to the US Department of Homeland Security (DHS, Washington, DC, http://www.dhs.gov/) in response to proposed DHS regulations on chemical site security, asking DHS to take into consideration the unique nature of the specialty batch manufacturing sector.

SOCMA is the US-based trade association representing custom and batch manufacturers. The association includes contract manufacturing organizations supplying active pharmaceutical ingredients and intermediates to the pharmaceutical industry as well as contract manufacturers supplying specialty chemical sectors.

In late December, the DHS proposed regulations on site security for high-risk chemical facilities. The proposed regulations require that chemical facilities fitting certain profiles complete a secure online risk assessment to determine overall risk. High-risk facilities will then be required to conduct vulnerability assessments and submit site-security plans that meet the department's performance standards.

SOCMA's comments may be found at: http:// http://www.socma.org/PDFfiles/gr_pdf_files/Socma_Comments_on_Chemical_Facility_Anti-Terrorism_Standards_2-6-07.pdf