May 2007 - Pharmaceutical Technology

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May 2007

Pharmaceutical Technology

The report also shows that the number of Warning Letters issued by the two centers has declined during the past 10 years. In 2006, CDER issued 66 Warning Letters, and CBER issued 22 Warning Letters.

-Erik Greb


FDA Submits Final Proposals for PDUFA IV

Rockville, MD (Mar. 23)—The US Food and Drug Administration (FDA, submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user fee on September 30, 2007. The law provides user-fee funds paid by brand drug and biotechnology companies that help support the review of new drugs.

According to an FDA release, annual user fees under PDUFA IV would increase to $392.8 million, an $87.4 million increase over PDUFA III.

The funds would support "key goals," including enhancing premarket review and creating a modern postmarket drug safety system that follows products across their full life cycle.

"Our proposed recommendations for PDUFA IV aim to strengthen our drug safety system and upgrade resources to enhance FDA's information technology capability," said Commissioner of Food and Drugs Andrew C. von Eschenbach, MD.

-Maribel Rios


DHS Releases Interim Final Rule on Chemical Site Security

Washington, DC (Apr. 2)—The US Department of Homeland Security (DHS, released an interim final rule that imposes federal security regulations on high-risk chemical facilities. The new rule gives the department authority to seek compliance through the imposition of civil penalties of as much as $25,000 per day and the ability to shut down noncompliant facilities.

Under the rule, DHS will require owners of chemical facilities that house certain quantities of specified chemicals to complete a preliminary screening assessment that determines the level of risk associated with the facility. If a chemical facility preliminarily qualifies as high-risk, its owners will be required to prepare and submit a security vulnerability assessment (SVA) and site-security plan. Submissions will be validated through audits and site inspections. The department will provide technical assistance to facility owners and operators as needed. Security standards will be required to achieve specific outcomes such as securing the perimeter and critical targets, controlling access, deterring theft of potentially dangerous chemicals, and preventing internal sabotage.

Facilities contacted by the department will have 120 days from the publication of the regulation in the Federal Register to provide information for the risk-assessment process. Other requirements will follow that time period. Additional facilities will follow a similar timeframe after future Federal Register publications.

Some states have existing laws for regulating chemical facilities. Only state laws and requirements that conflict or interfere with these regulations or the purpose of the regulations will be preempted. DHS says the department currently has no reason to conclude that any existing state laws are applied in a way that would impede the federal rule.

DHS says the final regulation will be published in the Federal Register and also may be found at

SOCMA responds to new rule

The Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC,, the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates, outlined its concerns about the new rule.


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