Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Sunday, August 5, 2012
Market Research Estimates European Active Pharmaceutical Ingredients (API) Market Growth at 6% CAGR Through 2017
To review this World News Article click here.
Cipla to set up API facilities
To read the article in the Economic Times, date August 5, 2012, click here.
K-V Pharmaceutical Files for Bankruptcy Protection
To read the article in Bloomberg Business week written by David E. Rovella on August 04, 2012, click here.
Friday, August 3, 2012
American Society for Pharmacy Law 2012--Session on Veterinary & Human Compounding
The American Society for Pharmacy Law 2012 Developments in Pharmacy Law Seminar XXIII in conjunction with National Alliance of State Pharmacy Associations, November 15-18, 2012 at Ventana Canyon Resort, Tucscon, Arizona, will include a session on Veterinary and Human Compounding. Click here for registration.
Drug Manufacturing or Compounding?
Thursday, August 2, 2012
Another Example of a Federal Prosecution Involving Compounded Drugs
Former Vice-President Of Pharmacutical Company Pleads Guilty To FDA Violations And Health Care Fraud
– Company received more than $2 million in payments from Medicare for misbranded, adulterated and contaminated inhalation medications
February 7, 2012
Johnny Perry, age 62, of Mt. Washington, Kentucky, was indicted by a federal grand jury in Louisville on August 3, 2011. The five count indictment alleged that between June of 2006 and June of 2008, Perry, as vice-president of NRS, provided compounded medications to patients, but led both Medicare and the patients’ doctors to believe that the pharmaceutical company was providing non-compounded medications (FDA approved-commercially manufactured). Compounded medications are not FDA approved, but FDA regulations permit pharmacists to make compounded drugs, including prescription drugs, in limited amounts and under narrow circumstances, for particular patients, and at the direction of a physician when other available drugs cannot be prescribed.
The defendant, through the NRS Corporation submitted false and fraudulent claims to Medicare for the cost of FDA-approved, commercially manufactured, prescription inhalation drugs, when they were not. As a result of this conduct, NRS received approximately $2,030,343 in payments from Medicare to which they were not legally entitled.
It is further alleged that Ms. Perry, aided and abetted by others, from November 2006 through June 2008, misbranded inhalation drugs in that they contained false and misleading labeling that misrepresented the strength and potency of their active ingredients or the type of drug actually provided. During the same period it is alleged that Perry, aided and abetted by others, adulterated inhalation drugs in that the strength differed from what it was purported or represented to possess and that the drugs were contaminated and non-sterile.
“This case should send a clear message that offenses endangering public health will be vigorously prosecuted,” stated U.S. Attorney David J. Hale. “Misrepresenting the strength and potency of a prescribed medication and delivering contaminated products to patients are unconscionable crimes.”
“The Office of Inspector General is committed to protecting the health of patients covered by Medicare and Medicaid,” said Derrick L. Jackson, Special Agent in Charge of the U.S. Department of Health and Human Services in Atlanta, Georgia, “This company billed for medications that never should have been dispensed in the first place which created serious quality of care concerns.”
The maximum potential penalties are 46 years in prison, a $770,000 fine, and supervised release for a period of 3 years.
The case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and Assistant United States Attorney James Lesousky, and it was investigated by the Food and Drug Administration, Health and Human Services Office of Inspector General, United States Postal Inspection Service, and the Federal Bureau of Investigation.
Press Release Found here.
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