On Monday, U.S. health officials warned that up to 13,000 Americans across 23 states could have been exposed to a strain of fungal meningitis that has been traced to contaminated steroid shots produced by a Massachusetts-based compounding pharmacy. The deadly meningitis outbreak — causing a potentially fatal inflammation of the brain or central nervous system — has already resulted in over 100 cases and eight deaths.
Although more than half of the estimated 56,000 U.S. pharmacies across the country practice compounding — repackaging or recombining medications on a large scale, in an attempt to keep down the costs of filling prescriptions — the FDA cannot oversee this sector of the pharmaceutical industry. The FDA has authority over drug manufacturers, not pharmacies, so drugs that are compounded at pharmacies do not currently have to meet the agency’s guidelines to ensure they are safe or effective.
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