The U.S. Senate has approved a bill that would regulate compounding pharmacies more heavily in the wake of last year's outbreak of fungal meningitis traced to a compounding pharmacy in Massachusetts, according to an article in the New York Times.
The bill gives the Food and Drug Administration more power to "police" compounding pharmacies in an attempt to make the drug supply safer. Compounders were previously subject to state law with limited federal oversight.
Under the Drug Quality and Security Act, compounders would register with the FDA as "outsourcing facilities" and be subject to quality control and oversight rules. Companies that mix medications for individual patients based on prescriptions would not be subject to the new federal oversights, according to the report. Companies that mixed limited quantities "ahead of prescription" would also fall between the cracks.
Finally, the bill would set up a drug tracking system.
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The bill gives the Food and Drug Administration more power to "police" compounding pharmacies in an attempt to make the drug supply safer. Compounders were previously subject to state law with limited federal oversight.
Under the Drug Quality and Security Act, compounders would register with the FDA as "outsourcing facilities" and be subject to quality control and oversight rules. Companies that mix medications for individual patients based on prescriptions would not be subject to the new federal oversights, according to the report. Companies that mixed limited quantities "ahead of prescription" would also fall between the cracks.
Finally, the bill would set up a drug tracking system.
More Articles on Surgery Centers:
9 Statistics on Surgery Center Assets by Number of ORs
12 Focus Areas to Boost Surgery Center Case Volume & Revenue in 2014
235 People in the ASC Industry to Know