Regulatory and Association News - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory and Association News

PTSM: Pharmaceutical Technology Sourcing and Management
Volume 3, Issue 2

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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here