The Law of Compounding Medications And Drugs

Marketed Unapproved Drugs and False Claims Act Activities

Forest Laboratories (Levothroid): FDA Press Release (issued September 15, 2010)⁶
Drug Maker Forest Pleads Guilty; Will Pay More Than $313 Million To Resolve Criminal Charges And False Claims Act Allegations
Forest Laboratories (Levothroid): FDA Press Release (issued March 2, 2011)⁷
Forest Pharmaceuticals To Pay $164 Million for Criminal Violations
Healthpoint, LTC (Xenaderm): Press Release (issued April 1, 2011)⁸
U.S. Files Complaint Against Texas-Based Healthpoint Ltd. Under the False Claims Act
Schwarz Pharma (Deponit and Hysocyamine Sulfate ER): Press Release (issued April 28, 2010)⁹
Schwarz Pharma Pays $22 Million to Settle False Claims Allegations Concerning Reimbursement for Unapproved Drugs

Information is found at FDA website located here.

Date :	31-Jul-2012
Subject :	EU's newly-changed rules on cGMP certificate for bulk drug exports
With the European Union (EU) changing the rules for importing active substances into EU for medicinal products for human use, India may convey the apprehensions of the Indian active pharmaceutical ingredients (API) exporters about the rising cost of transaction costs and seek exemption. The Commerce Ministry is learnt to have taken note of the changed rules by the EU to be made effective from January 2013 on making mandatory the current good manufacturing practices (cGMP) certificate from the local regulatory authority for all bulk drug exports. The industry had also apprised the Drug Controller General of India (DCGI) about the hardships including the increase in transaction costs due to the amended laws. Industry leaders, terming the new laws as another non-tariff trade barrier, had urged the Commerce Ministry and the DCGI to take up the matter with the European Union. Sources said India may convey these apprehensions to the EU in a formal way and seek exemption as sought by some countries like Israel and Switzerland. “The matter is under consideration of the authorities,”a senior official from the Commerce Department said. To read the remainder of the article click here.