Statement on FDA’s Warning Letter to Empower Pharmacy for producing drug products in violation of federal law

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“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.”

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Pill press update: February to July 2026

Between February and July, the media covered pill press seizures in 13 states and customs forfeiture records reported seizures of 16 pill presses, six capsule-filling machines, and over 300 pill press parts, dies, and molds. Learn more about the last six months in pill press news.

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