Compounding pharmacies in Michigan may soon operate under a system of tighter controls and regulations, and employees could face felony charges and prison sentences if patients are injured or die because the new rules are not followed.
The aim behind Senate bills 704 and 904, sponsored by Sen. Joe Hune, R-Hamburg, is to prevent the kind of injuries and deaths suffered in the state two years ago when the Framingham, Mass.-based New England Compounding Center allegedly sent tainted medicine to clinics around the country.
Michigan was the hardest hit when the tainted steroids were delivered to clinics in the state, resulting in 264 infections and 19 deaths. Nationwide, the death count hit 64 with 751 cases of fungal infections or meningitis, according to the Centers for Disease Control and Prevention.
"Hearing from constituents that have been so adversely impacted by these tainted steroids, it's the least we can do," Hune said.
Compounding pharmacies mix and assemble pharmaceuticals to create a drug or form of medicine needed by a patient.
Hune's bills would add a series of requirements for these businesses, including that accurate records of its procedures are maintained, that the pharmacies are subject to a physical state inspection once every two years and that all compounding pharmacies designate a "pharmacist-in-charge" responsible for making sure the business follows the state regulations.
The criminal penalties for violating the rules that result in personal injury include a maximum of a four-year prison sentence. A violation that resulted in a patient death would carry a maximum 15-year sentence.
The legislation would also give the state the ability to immediately suspend the pharmacy license of the business if notice was received by the CDC or the Food and Drug Administration of imminent risk to public health or safety.
Attorney General Bill Schuette's office has been working with Hune on the bill, and supports the legislation he says will protect patients and hold pharmacists accountable
continue to read here
The aim behind Senate bills 704 and 904, sponsored by Sen. Joe Hune, R-Hamburg, is to prevent the kind of injuries and deaths suffered in the state two years ago when the Framingham, Mass.-based New England Compounding Center allegedly sent tainted medicine to clinics around the country.
Michigan was the hardest hit when the tainted steroids were delivered to clinics in the state, resulting in 264 infections and 19 deaths. Nationwide, the death count hit 64 with 751 cases of fungal infections or meningitis, according to the Centers for Disease Control and Prevention.
"Hearing from constituents that have been so adversely impacted by these tainted steroids, it's the least we can do," Hune said.
Compounding pharmacies mix and assemble pharmaceuticals to create a drug or form of medicine needed by a patient.
Hune's bills would add a series of requirements for these businesses, including that accurate records of its procedures are maintained, that the pharmacies are subject to a physical state inspection once every two years and that all compounding pharmacies designate a "pharmacist-in-charge" responsible for making sure the business follows the state regulations.
The criminal penalties for violating the rules that result in personal injury include a maximum of a four-year prison sentence. A violation that resulted in a patient death would carry a maximum 15-year sentence.
The legislation would also give the state the ability to immediately suspend the pharmacy license of the business if notice was received by the CDC or the Food and Drug Administration of imminent risk to public health or safety.
Attorney General Bill Schuette's office has been working with Hune on the bill, and supports the legislation he says will protect patients and hold pharmacists accountable
continue to read here
