Outsourcing facilities must comply with specific labeling requirements, submit regular reports to the FDA, undergo inspections by the FDA, and report all adverse events to the FDA. Interestingly, outsourcing facilities cannot compound drugs that have been removed from the market by the FDA, compound demonstrably difficult preparations, and provide compounded preparations to wholesalers for resale.<\/p>\n
In summary, outsourcing facilities are legitimate entities that are able to fill a void for large-scale institutions such as hospitals or surgery centers. Outsourcing facilities can provide patient-specific and non-patient-specific medications. Traditional pharmacies, which may or may not register with the FDA, can continue providing patient-specific prescriptions pursuant to a valid prescription. As this relates to intrathecal drug therapy, traditional pharmacies can continue providing these medications to practices without FDA oversight. We will continue to remain vigilant to stay up-to-date and get the most current information that affects our practice “\u201c and we will have more to add as time goes on.<\/p>\n
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