Keeping you updated on the latest Medicare and Part D news

New FDA Oversight of Compounding Pharmacies

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Under the new Drug Quality and Security Act, the FDA gained the authority to regulate large-scale compounding pharmacies. After contaminated drugs from a compounding pharmacy in Massachusetts led to a deadly fungal meningitis outbreak in September 2012, the FDA demanded new regulations for large-scale compounding pharmacies. Traditional compounding pharmacies are allowed to mix and distribute individual prescriptions to order, and are regulated by the state. However, some compounding pharmacies now make specialized drugs on a large scale and distribute nationally. For example, the Massachusetts pharmacy responsible for the fungal meningitis outbreak had shipped over 17,600 potentially contaminated doses to 23 states. The FDA believes that these entities resemble drug manufacturers and cannot be regulated by state laws, which were written for small scale operations.

Large-scale compounding facilities can now register as “outsourcing facilities” with the FDA and submit to federal inspections and quality standards similar to those for drug manufacturers. This process is voluntary, so compounding pharmacies who chose not to register can continue to exist in a legal grey area between state and federal regulations. Currently, the FDA does not know how many compounding pharmacies exist in the US (the estimate is 700-1,000 operations), but plans to use complaints and state regulators to identify compounding pharmacies who do not register. The FDA also hopes that health care providers and hospitals will favor purchasing compounded products from registered pharmacies to encourage more facilities to accept FDA oversight.



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