With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The Alabama Department of Public Health (ADPH) released a list of 44 health care facilities in Alabama that received products from the compounding pharmacy, and nineteen Alabama residents have received contaminated steroid products from procedures performed in Tennessee and Florida. Although Dr. Don Williamson, State Health Officer, emphasized that the products shipped to Alabama facilities have no known association with the meningitis, nor have they been proven to be contaminated, both physician and patient alike have examined their use of compounded medications and whether or not they should be brought under greater regulatory scrutiny.
According to reports, there are approximately 3,000 compounding pharmacies across the country. Drugs made by these facilities represent as much as 3% of the roughly $300 billion in prescription drugs sold in the U.S. each year, according to the International Academy of Compounding Pharmacists.
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Topics: Drug Compounding, FDA, FDAMA, FDCA, Meningitis, Pharmacies
Administrative Law Updates, Health Law Updates, Products Liability Updates, Science, Computers & Technology Updates
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