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

September 23, 2026 (Washington DC) – Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement about the warning letter the FDA issued today to Empower Clinic Services, LLC dba Empower Pharmacy for producing adulterated, misbranded, and unapproved drug products in violation of federal law.

"The FDA’s warning to Empower Pharmacy is welcome and overdue. The deadline for compounders to stop mass producing GLP-1s has long passed, and yet the nation’s largest compounding pharmacies continue to deliberately ignore the laws.

“In doing so, compounders, telehealth platforms, and med spas peddle unauthorized versions of injectable medicines that jeopardize Americans’ safety.

"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.

“This single finding reaches far beyond GLP-1s. The compounded peptide market, the med-spa injection industry, and the telehealth platforms supplying them are all built on exactly this model. Mass prescribing disguised as individualized care isn't permissible compounding.

“We applaud the FDA for formally reaffirming that premise. A warning letter, however, is just that – a warning. Are existing enforcement mechanisms sufficient deterrence for compounders who profit at the expense of patient safety?

“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.”