Tuesday, March 5, 2013

TN drug compounding bill loses safeguard Meningitis culprit broke the same rule this bill would erase

March 5, 2013

Six months after moldy medicine caused an outbreak of a deadly new form of meningitis, Congress does not have a single bill before it to improve regulation of compounding pharmacies, and the only legislation proposed in Tennessee would strip away an important safeguard.
The one proposal pending before the Tennessee General Assembly would eliminate the requirement that compounded drugs be prepared only with a patient-specific prescription.
New England Compounding Center, the maker of the moldy medicine, violated this requirement when it mass-produced and sold steroid drugs that were injected into people’s spines as a pain treatment, federal and state regulators have charged.
The sponsor of the state legislation, Sen. Ferrell Haile, R-Gallatin, is a pharmacist.
“Right now I cannot compound for more than one individual at a time,” Haile said. “That’s why we had all this stuff coming in from other states.”
The effort by Haile is in direct contrast to the situation in California, where the state pharmacy board and some legislators are working to eliminate an existing provision in California law that mirrors the provision in Haile’s bill.
Virginia Herold of the California Pharmacy Board said a pending bill would eliminate a so-called prescriber’s exemption allowing production of compounded drugs without patient-specific prescriptions under certain circumstances.
Traditionally, compounding was used by pharmacists to create a custom medication specifically for one patient.
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