More Cases That Show the Problems With Compounded Medications Are Not As Isolated ast he Compounding Pharmacists Would Want You to Believe

March 6, 2006: An Alabama pharmacist pleads guilty to health fraud and drug misbranding in the case referenced below. The pharmacist could receive a maximum of 13 years in prison and fines totalling $260,000.00. The DOJ press release reads:

HALEYVILLE PHARMACIST PLEADS GUILTY TO HEALTH CARE FRAUD AND DRUG MISBRANDING

BIRMINGHAM, AL - GERALD BURLESON pled guilty today to two counts of a Federal Information charging him with Health Care Fraud and Drug Misbranding. The guilty plea is announced today by U.S. Attorney Alice H. Martin, Special Agent in Charge Federal Bureau of Investigation, Carmen Adams, and Special Agent in Charge U.S. Department of Health and Human Services, Linda Little.

According to U.S. Attorney Alice H. Martin, BURLESON, 63, of Haleyville pled guilty to defrauding Medicare in connection with drugs dispensed to Medicare patients by City Pharmacy of Haleyville. BURLESON, who operated the pharmacy, received orders from physicians prescribing medications which were commercially available in the strengths prescribed. Instead of dispensing medications as ordered by the physicians, BURLESON dispensed medication that he had compounded from ingredients acquired by him, and billed Medicare more than the cost of commercially available doses. BURLESON then placed his compound medication into vials which were dispensed to patients, without the physicians’ knowledge, and at an unlicensed location. BURLESON filed claims with Medicare and received reimbursement for the medications he dispensed. BURLESON also pled guilty to Drug Misbranding which related to dispensing the compounded medications to a specific patient.

“Cheating Medicare won’t be tolerated,” stated U.S. Attorney Alice H. Martin. “Health Care Providers who use fraud and deceit to abuse the system will be prosecuted to the fullest extent of the law,” added U.S. Attorney Martin.

BURLESON could receive a maximum of 13 years in prison and files totaling $260,000. Sentencing will be scheduled by U.S. District Judge Scott Coogler for a later date.

Special Agents of the Office of Inspector General, Department of Health and Human Services, the Office of Criminal Investigations, Food and Drug Administration; and the Federal Bureau of Investigation have investigated this case. Assistant United States Attorney Hubert H. Henry is prosecuting this case on behalf of the U.S. Government.

2006 : An Alabama pharmacist has been charged with one count of Health Care Fraud and one count of Drug Misbranding in a case alleging the pharmacist “defrauded Medicare in connection with drugs dispensed to Medicare patients”. Instead of dispensing medications as ordered by the physicians, the pharmacist is alleged to have dispensed medication that he compounded from ingredients he had acquired, without the physicians' knowledge. According to the DOJ press release, the Drug Misbranding charge “alleges acts related to dispensing the compounded medications to a specific patient” [see press release].

2005 : In a scheme to defraud Medicaid, two individuals were arrested for allegedly making a “rudimentary homemade mixture of chemicals” found in FDA-approved medications and using their pharmacy to sell counterfeit drugs to patients with serious medical conditions including cystic fibrosis. On chemical analysis, FDA found one of the chemicals used in compounding was contaminated with bacteria and did not conform with standards that apply to starting materials used in FDA-approved products.

2003: A home-care pharmacy in Missouri distributed more than 1.3 million doses of compounded nebulizer medicines to an estimated 18,000 patients nationwide—samples of the drugs were found to be contaminated with a pathogenic lung bacteria. The Missouri State Board of Pharmacy found the pharmacy failed to completely recall the medicines and did not adequately inform physicians and patients to the contamination risk.

2002 : Two Florida pharmacists were convicted of Medicare Fraud in July of 2002 for their role in the large-scale compounding of adulterated respiratory medicines by unlicensed individuals under unsanitary conditions. During the trial, testimony from an expert witness for the defense highlighted larger respiratory compounding operations throughout the U.S., hinting at the prevalence of respiratory drug compounding operations.

2001: A pharmacy in California issued a Class I Recall of thousands of doses of compounded respiratory medications distributed to managed care patients because they were contaminated with Serratia Liquiformins. A subsequent Warning Letter issued by the FDA noted the agency’s serious concern about the public health risks associated with “large-scale production of massive quantities of inhalation solutions without these products being required to meet all the laws and regulations applicable to a drug manufacturer". After a joint inspection with the California Board of Pharmacy, the FDA found the pharmacy did not have the proper training, equipment or control procedures in place to ensure the quality of dosage forms produced, and testing of finished drug products was inadequate to ensure the drugs’ potency, purity and sterility. The FDA found the next batch of medication made at the firm was also contaminated.

quoted from here