Archive for April 2012

USP Will Hold Workshop on Supply Chain Integrity May 22-23

The United States Pharmacopeial Convention (USP) is hosting a two day workshop on good distribution practices and supply chain integrity in Rockville, MD. The objectives of the workshop are To discuss the breadth of current issues, regulations and solutions. Obtain additional  input for USP General Chapter <1083>. Identify opportunities for USP's role in supply chain…

[...]

MHRA Seizes £14 Million in Assets from Convicted UK Drug Counterfeiter

The United Kingdom’s Medicine & Healthcare Products Regulatory Agency (MHRA) has seized £14.4 million in assets from convicted counterfeit medicine dealer, Simon Martin Hickman. Hickman was sentenced to two years imprisonment in June 2009 following his conviction for both selling and supplying fake and unlicensed drugs,and money laundering. After an investigation of his assets, the…

[...]

Pillai DR., Lau R, Khairnar K, et al. Artemether resistance in vitro is linked to mutations in PfATP6 that also interact with mutations in PfMDR1 in travellers returning with Plasmodium falciparum infections. Malar J. 2012, 11:131.

Abstract Background Monitoring resistance phenotypes for Plasmodium falciparum, using in vitro growth assays, and relating findings to parasite genotype has proved particularly challenging for the study of resistance to artemisinins. Methods Plasmodium falciparum isolates cultured from 28 returning travellers diagnosed with malaria were assessed for sensitivity to artemisinin, artemether, dihydroartemisinin and artesunate and findings related…

[...]

Two Israeli Citizens Plead Guilty to Importing Counterfeit Drugs to US

View larger map Two Israeli citizens, Benny Carmi and Moshe Dahan, pleaded guilty to smuggling counterfeit and misbranded drugs in the US. The Food and Drug Administration Office of Criminal Investigations (OCI) explained that “both men operated an Internet business in Israel that used multiple websites, including ‘allpillsrx.com,’ ‘newpharm.net,’ and others to illegally sell large…

[...]

FDA Alert: Recall of X-Rock for Men Due to Undeclared Active Ingredient

This is a reprint of the FDA alert. XROCK INDUSTRIES, LLC Issues a Voluntary Nationwide Recall of X-ROCK, a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Unlisted, Potentially Hazardous Ingredient XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold…

[...]

NABP Release Year End 2011 Data: Fake Pharmacies Proliferate, the Many Controlled by the Few

The National Association of Boards of Pharmacy has released year end data on safe online pharmacies showing the rise of the “affiliate network.”

While the number of legitimate online pharmacies safe for Americans remains at 4% of all, the growth of fake online pharmacies out of compliance with U.S. pharmacy laws and practice standards appears to be strongly linked to the spread of underlying source organizations called “affiliate networks” that proliferate the internet with copies of their websites.

The NABP has published a report, “Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2012” which identifies 8,456 so-called online pharmacies that are out of compliance with U.S. pharmacy laws and practice standards. Of those, 8,265 appear to be network affiliated, 98%.

The NABP staff identified websites that use the same phone number, physical address, domain name registrant, website design or web business name as those being part of a rogue affiliate network. A rogue affiliate network is a group of internet drug outlets operated by one organization, which are frequently operated outside of the U.S.

“The common perception in America is that a discount retailer out there on the internet can, because of lower costs of business elsewhere, provide medication at below U.S. market rates. What they don’t know is that the medications are all coming from the same counterfeiters in India and China, and that a giant conglomerate of organized crime runs these hundreds of millions of websites that advertise as if they were ‘mom and pop’ small pharmacies on the internet,” said Carmen Catizone, NABP’s Executive Director.

[...]