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.

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval Unapproved Drugs Initiative

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval Unapproved Drugs Initiative

Consumer Updates Use Caution with Over-the-Counter Creams, Ointments

Consumer Updates Use Caution with Over-the-Counter Creams, Ointments

Stop online sales of counterfeit drugs, say industry big boys

Stop online sales of counterfeit drugs, say industry big boys

Eu's Newly-Changed Rules On Cgmp Certificate For Bulk Drug Exports

Eu's Newly-Changed Rules On Cgmp Certificate For Bulk Drug Exports

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.

USA: Prescription drug case; ex-Cabell County doctor enters guilty plea

USA: Prescription drug case; ex-Cabell County doctor enters guilty plea

Gustavo Buenrostro in Scandal Involving Prescription Medication Services Company

An indictment returned charges Gustavo Buenrostro, 49, of Arlington Heights with conspiracy to commit bribery in a scandal involving a prescription medication services company. To read entire article, click here.

High Drug Prices Fuel Medicaid Fraud and U.S. Drug Safety Problems

High Drug Prices Fuel Medicaid Fraud and U.S. Drug Safety Problems

Additional Briefs That Have Been Filed in U.S. v. Gary D. Osborn and Apothecure

To view Gary D. Osborn's Brief Relating to Apprendi/Fine argument click here.
To view Government's Response Brief to Osborn's Apprendi/Fine argument click here.
To view Government's Reply Brief click here.

APhA Publishes Fourth Edition of The Art, Science and Technology of Pharmaceutical Compounding

July 25, 2012
WASHINGTON, DC – The American Pharmacists Association (APhA) recently published the fourth edition of the leading textbook on pharmaceutical compounding, The Art, Science and Technology of Pharmaceutical Compounding.
The book is geared to both student pharmacists taking laboratory classes and practicing pharmacists. In a logical and progressive format, it presents all the information a student needs to understand the purpose and processes of compounding. It includes the essential information on establishing, equipping and operating a compounding pharmacy. It discusses all aspects of good manufacturing practices for compounded medications and it features quality control measures for all aspects of compounding.
For practitioners who already compound prescription medications, the hardbound book is a ready reference featuring more than 200 sample formulations, including bases, vehicles and ingredient-specific preparations. Each formulation lists the necessary ingredients and gives step-by-step instructions for preparing the product. A new chapter emphasizes the importance of knowing the purity and form of all ingredients to ensure that the proper dose of a compounded product is delivered.
The book is authored by Loyd V. Allen Jr., PhD, Editor in Chief of the International Journal of Pharmaceutical Compounding, Edmond, OK, and Professor Emeritus at the College of Pharmacy, University of Oklahoma, Oklahoma City. Allen has written more than 200 refereed publications and abstracts in the scientific and professional literature. He is a principal author of Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems and he has written a monthly compounding column since 1988 for the trade journal U.S. Pharmacist.
To read remainder of news article and for information on ordering click here.