The United States: Federal judge enters consent decree against Cantrell Drug Company (English Only)
 
The United States (US) District Judge Kristine G. Baker for the Eastern District of Arkansas entered a consent decree of permanent injunction on 19 April 2018 between US and Cantrell Drug Company of Little Rock, Arkansas, and the company’s Chief Executive Officer and co-owner, James L. McCarley, Jr. 

The consent decree prohibits Cantrell and McCarley from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Food and Drug Administration (FDA) regulations, in addition to other requirements. 

The complaint filed with the consent decree alleges that Cantrell manufactured and distributed purportedly sterile drug products, such as injectable opioids and antibiotics, that were adulterated under the FD&C Act because the drugs were made under insanitary conditions and in violation of current good manufacturing practice (CGMP) requirements. Drugs that are prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health are adulterated under the FD&C Act. 

The consent decree requires Cantrell to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company is complying with the FD&C Act and CGMP requirements. Under the consent decree, Cantrell cannot resume operations until it receives authorization from the FDA. 

Cantrell is registered as an outsourcing facility under section 503B of the FD&C Act. The Drug Quality and Security Act, signed into law on 27 November 2013, added a new section -- 503B – to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility. Outsourcing facilities must comply with CGMP requirements, are inspected by the FDA according to a risk-based schedule and must meet certain other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound. 

The complaint was filed by the US Department of Justice on behalf of the FDA. 

Please refer to the following website in FDA for details: http://www.fda.gov/NewsEvents/Newsroom/../ucm605199.htm 

In Hong Kong, there is no registered pharmaceutical product manufactured by the above company. Related news has been issued by US FDA, and was posted on the Drug Office website on 22 November 2016, 26 July 2017 and 2 March 2018. 

Ends/ Friday, April 20, 2018 
Issued at HKT 17:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/ 
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