“Don’t overlook the most consequential finding in this letter. The FDA flagged prescriber determinations that appeared verbatim across hundreds of patient records – like copy-pasted language, pre-loaded for selection, never actually written for an individual patient. The FDA made clear that approach does not meet the bar for prescribing a compounded drug, which must be tailored to the needs of an individual patient.
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“The FDA must follow this letter with action – seizures and injunctions where warranted – and Congress should work quickly to close the policy gaps that have allowed this shadow drug supply to persist. Patients deserve medicines they can trust.”