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Massachusetts seeks compliance statements from pharmacies

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Wed Oct 10, 2012 5:18pm EDT

(Reuters) - After a nationwide meningitis outbreak was tied to drugs shipped from a plant in Massachusetts, the state is requiring all pharmacy compounders to sign a statement saying they are complying with regulations on their work, officials said on Wednesday.

The Massachusetts Department of Public Health also confirmed that compounder Ameridose LLC has agreed to close temporarily. Ameridose shares ownership with the New England Compounding Center that shipped thousands of vials of steroid drugs linked to the meningitis outbreak.

The actions follow concerns that NECC and other compounding pharmacies, which produce custom-made versions of medications for doctors, hospitals and clinics, have violated laws that allow them to alter drugs based on the needs of individual patients rather than produce large batches of medication for sale.

NECC shipped more than 17,000 vials of the steroid methylprednisolone acetate to healthcare facilities in a number of states. The medication, used mostly for back pain, has infected 137 people across 10 states, killing 12, according to the Centers for Disease Control and Prevention.

(Reporting by Sharon Begley; Editing by Gary Hill)
U.S.
Health
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Comments (1)
tyg wrote:
It seems the State of Massachusetts questions their pharmacists are capable of following the law. Why does the state need a statement after it licenses these pharmacies, which appear to be manufacturing more than some small drug companies, to re-state they are following the laws. It is too little too late for the people affected by pharmacy compounding which is more than it was traditionally meant to be, specialized doses to complement drugs approved by the federal authorities. Pharmacy compounding is virtually an unregulated area of drug manufacturing, which will continue to be an extremely lucrative venture where the pharmaceutical industry may set its sights. How can you explain the demand for distributing over 17,000 doses to 23 states? Are there no approved drugs for this kind of pain? I remember when a dermatologist told me that he had to design a specific type of drug for me and that I can have it filled it at the door before leaving her practice. I was surprised at the speed of the pharmacy compounding of my special and tailored medicine as the cashier pulled it already labeled and packaged.

Oct 10, 2012 9:19pm EDT  --  Report as abuse
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